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Should we abandon minimally invasive surgery for cervical cancer?
A minimally invasive approach for gynecologic surgery increasingly has become the surgical modality of choice (vs open surgery) due to decreased perioperative and postoperative morbidity for many gynecologic cancers.1-3 This has included radical hysterectomy for cervical cancers. Until recently, retrospective evidence supported its use, suggesting decreased perioperative and postoperative complications with similar survival outcomes between patients undergoing minimally invasive and open radical hysterectomy.4,5 In November 2018, two new studies were published in the New England Journal of Medicine, and another study was presented at the American Society of Clinical Oncology (ASCO) annual meeting challenging this practice paradigm. These studies reveal a higher risk of disease recurrence and decreased overall survival with minimally invasive surgery (MIS) compared with open surgery for Stages IA–IB1 cervical cancer. These findings have resulted in a change in practice nationwide.
RCT findings astonish specialty
The first study, the Laparoscopic Approach to Cervical Cancer (LACC) trial, authored by Ramirez and colleagues was a noninferiority randomized controlled trial evaluating MIS versus open radical hysterectomy for patients with cervical cancer (Stage 1A–1B1) conducted from 2008–2017.6 The primary outcome was disease-free survival at 4.5 years. Secondary outcomes included recurrence and overall survival rates. Power analysis suggested a sample size of 740 patients to provide greater than 80% power with a noninferiority margin of -7.2% between disease-free rates of the two groups. However, the study was closed prematurely at enrollment of 631 patients (85% recruitment) by the Data Safety Monitoring Committee due to the astounding differences in survival between the two groups.
The rate of disease-free survival at 4.5 years was 86.0% with MIS and 96% with open surgery. There were 27 recurrences (8.5%) in the MIS group and only 7 (2.2%) in the open-surgery group, accounting for a hazard ratio (HR) for disease recurrence or death from cervical cancer of 3.74 (95% confidence interval [CI], 1.63–8.58). This difference remained after adjusting for confounding variables. There were 22 deaths—19 (5.9%) in the MIS group and 3 (0.1%) in the open-surgery group (HR, 6.56). Although patient characteristics between groups appeared to be similar, more than one-third of patients in each group had missing data regarding histology at the time of surgery, grade, tumor size, lymphovascular space invasion, and depth of invasion. Interestingly, intraoperative, perioperative, and postoperative complications between the two groups were similar (with rates of 11%, about 40%, and about 25%, respectively).
Surprising findings continue in NEJM
The second study, by Melamed and colleagues, was a retrospective cohort study using data from the National Cancer Database (NCDB) and the Surveillance, Epidemiology, and End Results (SEER) database evaluating women with stage IA2 or IB1 cervical cancer who underwent either minimally invasive or open radical hysterectomy between 2010 and 2013.7 The primary outcome was time to death.
Participant characteristics. A total of 2,461 women were included: 49.8% underwent MIS and 50.2% underwent open surgery. According to the raw data, patients undergoing MIS were more likely to be white, privately insured, reside in an area associated with higher income, undergo surgery at a nonacademic institution, have adenocarcinoma, and have smaller, lower-grade tumors. After propensity-score weighting, demographic and clinical characteristics were similar between groups. Median follow-up was 45 months.
Results. A total of 164 deaths occurred: 94 in the MIS and 70 in the open-surgery group. The risk of death during study follow-up was 9.1% in the MIS group versus 5.3% in the open-surgery group, and women who underwent MIS had shorter overall survival (P = .002; HR, 1.65; 95% CI, 1.22–2.22). Mortality rates remained higher in the MIS group after adjusting for adjuvant therapy (HR, 1.62; 95% CI, 1.2–2.19). However, the HR for death with MIS was not statistically significant in a subgroup analysis evaluating tumors 2 cm in size or less (HR, 1.46; 95% CI, 0.70–3.02). The authors demonstrated that the adoption of MIS for radical hysterectomy corresponded to a drop in the 4-year survival rate of 0.8% per year (P = .01).
Continue to: ASCO meeting data emphasize lower...
ASCO meeting data emphasize lower mortality and survival rates for MIS
A third important, but less publicized study, is a retrospective cohort study by Marguland and colleagues that was presented at the ASCO annual meeting and is pending publication. This study evaluated the 5-year survival of women with stage IB1 cervical cancer after MIS or open radical hysterectomy from 2010 to 2013.8 The findings demonstrated similar results to the above studies with decreased 5-year survival rates in patients with a tumor size of 2 cm or greater in the MIS group (81.3% vs 90.8; HR, 2.14; 95% CI, 1.36–3.38; P<.001). These results hold true when controlling for confounding clinical variables. Interestingly, in a subset analysis evaluating patients with tumors less than 2 cm, survival rates were similar between groups. This study confirms decreased morbidity and cost associated with MIS radical hysterectomy.
A consistent message emerges from 3 independent studies
We must take the study findings seriously and evaluate the quality of the evidence. There are many strengths to the above studies. First and most importantly, the LACC study is the only prospective randomized controlled trial (RCT) to evaluate this very important clinical question. RCTs are the gold standard for understanding the effectiveness and safety of an intervention compared with an established treatment. The study was well designed in that the study population was clearly defined with detailed inclusion and exclusion criteria. The intention to treat analysis was similar to the per-protocol analysis, and the study followed Consolidated Standards of Reporting Trials (CONSORT) guidelines. While the study was stopped early, there was still 84% power for the primary outcome. Therefore, when it comes to MIS for cervical cancer, this study provides the soundest data we have available. It is also extremely noteworthy that two additional large retrospective studies evaluating this question separately found similar results.
Criticisms remain, but older research has drawbacks
A main concern with these studies is that the findings challenge previously published research, which overall suggest similar survival outcomes between MIS and open surgical approaches. However, in evaluating the previously published retrospective data it is clear that the studies have considerable limitations.
Long-term survival not always evaluated in research. First, the majority of studies comparing MIS and open treatment modalities specifically evaluated perioperative complications and did not consider long-term survival.4,9,10 Of those studies that did consider survival outcomes, the groups often were not balanced and were skewed toward the open surgery patients having larger tumors and higher-stage disease.5
Difficult to compare “apples to apples.” These findings are complicated by the fact that open radical hysterectomies were essentially replaced by MIS radical hysterectomies, and therefore, the comparisons are not equivalent since they are comparing different treatment times. For instance, throughout the time period many of these studies were conducted, the treatment paradigm for early-stage cervical cancer changed regarding who received adjuvant therapy and imaging techniques. Therefore, these studies are not comparing apples to apples.11,12
Are we going to increase morbidity? Another common concern when considering abandoning MIS for cervical cancer is the increase in morbidity that our patients may incur immediately postoperatively due to open surgery. Multiple studies have associated minimally invasive radical hysterectomies with decreased blood loss, shorter hospital stay, lower transfusion rates, and decreased time until return of bowel function.4,10,13
Continue to: While we recognize that...
While we recognize that open surgery is associated with increased morbidity, we do argue that, with the almost-universal implementation of Enhanced Recovery Pathways (ERP) in gynecologic oncology, the disparities between the two groups will be minimized and likely are much smaller than that reported in historical literature.14 Notably, there were no differences in peri-, intra-, or postoperative complications between the two groups in the LACC study, indicating that MIS may not be saving our patients as much morbidity as we think.
Surgical ability differences. Despite the vast strengths associated with the studies we have discussed they certainly embody limitations as well. First, surgical aptitude is difficult to evaluate and tease out. This is extremely pertinent given perioperative, and postoperative, outcomes in cervical cancer, as well as survival outcomes, in multiple surgically managed cancers, which are directly associated with the volume and proficiency of the surgeon.15-19 Additionally, the mode of minimally invasive surgery that was most commonly utilized was different from practice in the United States. Eighty four percent of the patients in the MIS group of the LACC study underwent laparoscopic and 13.6% underwent robot-assisted radical hysterectomy. This is starkly different from US practice, where 75% of gynecologic oncologists report performing radical hysterectomies only robotically.20
Take-home points
Consider this latest evidence in your surgical planning. Most importantly, the evidence is the evidence. In other words, we can attempt to explain away the findings, but despite arguments against these studies, these data are the most reliable evidence we have to date regarding outcomes for cervical cancer with MIS versus open approaches. These data demonstrate that MIS may be harming our patients and so we must take this into careful consideration during surgical planning.
For small cancers, MIS may be the best option. MIS radical hysterectomy may still be the best approach for patients with tumors less than 2 cm in size. The LACC study is not powered to evaluate oncologic outcomes in this subset of patients and the two retrospective studies suggest no difference in survival in this cohort.
We must work to understand the driving force between the disparate outcomes. Are the increased rates due to the open surgical approach, the uterine manipulator, circulating CO2 gas, or tumor exposure to the intraperitoneal cavity as the authors suggest? Or is it due to surgical expertise, tumor biology, tumor size, or mode of MIS? At this point the impelling cause is unknown.
New NCCN guidelines are to come. Up to this point the National Comprehensive Cancer Network (NCCN) guidelines stated that “radical hysterectomy procedure may be performed either via laparotomy or laparoscopy.” Given these recent studies, however, new NCCN guidelines will be released cautioning the use of the MIS approach. In short, these data have transformed the standard of care.
At our institution, the majority of radical hysterectomies will be performed open. Continued discussion remains regarding small lesions, but even in these cases most surgeons will proceed with open surgery in an attempt to maximize survival.
As providers, it is our duty to honestly reflect on published data and comprehensively counsel patients about the risks and benefits associated with each approach, including the fact that recurrence may be higher with a minimally invasive approach. Patients and providers must then collectively decide what is best for each individual case.
- Walker JL, Piedmonte MR, Spirtos NM, et al. Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study LAP2. J Clin Oncol. 2009;27:5331-5336.
- Zanagnolo V, Minig L, Rollo D, et al. Clinical and oncologic outcomes of robotic versus abdominal radical hysterectomy for women with cervical cancer: experience at a referral cancer center. Int J Gynecol Cancer. 2016;26:568-574.
- Wallin E, Floter Radestad A, et al. Introduction of robot-assisted radical hysterectomy for early stage cervical cancer: impact on complications, costs and oncologic outcome. Acta Obstet Gynecol Scand. 2017;96:536-542.
- Sert BM, Boggess JF, Ahmad S, et al. Robot-assisted versus open radical hysterectomy: a multi-institutional experience for early-stage cervical cancer. Euro J Surg Oncol. 2016;42:513-522.
- Shah CA, Beck T, Liao JB, et al. Surgical and oncologic outcomes after robotic radical hysterectomy as compared to open radical hysterectomy in the treatment of early cervical cancer. J Gynecol Oncol. 2017;28:e82.
- Ramirez PT, Frumovitz M, Pareja R, et al. Minimally invasive versus abdominal radical hysterectomy for cervical cancer. N Engl J Med. 2018;379:1895-1904.
- Melamed A, Margul DJ, Chen L, et al. Survival after minimally invasive radical hysterectomy for early stage cervical cancer. N Engl J Med. 2018;379:1905-1914.
- Margul DJ, Yang J, Seagle BL, et al. Outcomes and costs of open, robotic, and laparoscopic radical hysterectomy for stage IB1 cervical cancer. J Clin Oncol. 2018;36(15 suppl):5502.
- Geetha P, Nair MK. Laparoscopic, robotic and open method of radical hysterectomy for cervical cancer: a systematic review. J Minim Access Surg. 2012;8:67-73.
- Jin YM, Liu SS, Chen J, et al. Robotic radical hysterectomy is superior to laparoscopic radical hysterectomy and open radical hysterectomy in the treatment of cervical cancer. PloS One. 2018;13:e0193033.
- Rotman M, Sedlis A, Piedmonte MR, et al. A phase III randomized trial of postoperative pelvic irradiation in Stage IB cervical carcinoma with poor prognostic features: follow-up of a gynecologic oncology group study. Int J Radiation Oncol, Biol, Phys. 2006;65:169-176.
- Peters WA 3rd, Liu PY, Barrett RJ 2nd, et al. Concurrent chemotherapy and pelvic radiation therapy compared with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cancer of the cervix. J Clin Oncol. 2000;18:1606-1613.
- Uppal S, Liu RJ, Reynolds KR, et al. Trends and comparative effectiveness of inpatient radical hysterectomy for cervical cancer in the United States (2012-2015). Gynecol Oncol. 2018. pii: S0090-8258(18)31246-0.
- Barber EL, Van Le L. Enhanced Recovery Pathways in Gynecology and Gynecologic Oncology. Obstetr Gynecol Surv. 2015;70:780-792.
- Morche J, Mathes T, Pieper D. Relationship between surgeon volume and outcomes: a systematic review of systematic reviews. Syst Rev. 2016;5:204.
- Persson J, Reynisson P, Borgfeldt C, et al. Robot assisted laparoscopic radical hysterectomy and pelvic lymphadenectomy with short and long term morbidity data. Gynecol Oncol. 2009;113:185-190.
- Woelk JL, Casiano ER, Weaver AL, et al. The learning curve of robotic hysterectomy. Obstetr Gynecol. 2013;121:87-95.
- Yim GW, Kim SW, Nam EJ, et al. Learning curve analysis of robot-assisted radical hysterectomy for cervical cancer: initial experience at a single institution. J Gynecol Oncol. 2013;24:303-312.
- Vickers AJ, Bianco FJ, Serio AM, et al. The surgical learning curve for prostate cancer control after radical prostatectomy. J Natl Can Inst. 2007;99:1171-1177.
- Conrad LB, Ramirez PT, Burke W, et al. Role of minimally invasive surgery in gynecologic oncology: an updated survey of members of the Society of Gynecologic Oncology. Int J Gynecol Cancer. 2015;25:1121-1127.
A minimally invasive approach for gynecologic surgery increasingly has become the surgical modality of choice (vs open surgery) due to decreased perioperative and postoperative morbidity for many gynecologic cancers.1-3 This has included radical hysterectomy for cervical cancers. Until recently, retrospective evidence supported its use, suggesting decreased perioperative and postoperative complications with similar survival outcomes between patients undergoing minimally invasive and open radical hysterectomy.4,5 In November 2018, two new studies were published in the New England Journal of Medicine, and another study was presented at the American Society of Clinical Oncology (ASCO) annual meeting challenging this practice paradigm. These studies reveal a higher risk of disease recurrence and decreased overall survival with minimally invasive surgery (MIS) compared with open surgery for Stages IA–IB1 cervical cancer. These findings have resulted in a change in practice nationwide.
RCT findings astonish specialty
The first study, the Laparoscopic Approach to Cervical Cancer (LACC) trial, authored by Ramirez and colleagues was a noninferiority randomized controlled trial evaluating MIS versus open radical hysterectomy for patients with cervical cancer (Stage 1A–1B1) conducted from 2008–2017.6 The primary outcome was disease-free survival at 4.5 years. Secondary outcomes included recurrence and overall survival rates. Power analysis suggested a sample size of 740 patients to provide greater than 80% power with a noninferiority margin of -7.2% between disease-free rates of the two groups. However, the study was closed prematurely at enrollment of 631 patients (85% recruitment) by the Data Safety Monitoring Committee due to the astounding differences in survival between the two groups.
The rate of disease-free survival at 4.5 years was 86.0% with MIS and 96% with open surgery. There were 27 recurrences (8.5%) in the MIS group and only 7 (2.2%) in the open-surgery group, accounting for a hazard ratio (HR) for disease recurrence or death from cervical cancer of 3.74 (95% confidence interval [CI], 1.63–8.58). This difference remained after adjusting for confounding variables. There were 22 deaths—19 (5.9%) in the MIS group and 3 (0.1%) in the open-surgery group (HR, 6.56). Although patient characteristics between groups appeared to be similar, more than one-third of patients in each group had missing data regarding histology at the time of surgery, grade, tumor size, lymphovascular space invasion, and depth of invasion. Interestingly, intraoperative, perioperative, and postoperative complications between the two groups were similar (with rates of 11%, about 40%, and about 25%, respectively).
Surprising findings continue in NEJM
The second study, by Melamed and colleagues, was a retrospective cohort study using data from the National Cancer Database (NCDB) and the Surveillance, Epidemiology, and End Results (SEER) database evaluating women with stage IA2 or IB1 cervical cancer who underwent either minimally invasive or open radical hysterectomy between 2010 and 2013.7 The primary outcome was time to death.
Participant characteristics. A total of 2,461 women were included: 49.8% underwent MIS and 50.2% underwent open surgery. According to the raw data, patients undergoing MIS were more likely to be white, privately insured, reside in an area associated with higher income, undergo surgery at a nonacademic institution, have adenocarcinoma, and have smaller, lower-grade tumors. After propensity-score weighting, demographic and clinical characteristics were similar between groups. Median follow-up was 45 months.
Results. A total of 164 deaths occurred: 94 in the MIS and 70 in the open-surgery group. The risk of death during study follow-up was 9.1% in the MIS group versus 5.3% in the open-surgery group, and women who underwent MIS had shorter overall survival (P = .002; HR, 1.65; 95% CI, 1.22–2.22). Mortality rates remained higher in the MIS group after adjusting for adjuvant therapy (HR, 1.62; 95% CI, 1.2–2.19). However, the HR for death with MIS was not statistically significant in a subgroup analysis evaluating tumors 2 cm in size or less (HR, 1.46; 95% CI, 0.70–3.02). The authors demonstrated that the adoption of MIS for radical hysterectomy corresponded to a drop in the 4-year survival rate of 0.8% per year (P = .01).
Continue to: ASCO meeting data emphasize lower...
ASCO meeting data emphasize lower mortality and survival rates for MIS
A third important, but less publicized study, is a retrospective cohort study by Marguland and colleagues that was presented at the ASCO annual meeting and is pending publication. This study evaluated the 5-year survival of women with stage IB1 cervical cancer after MIS or open radical hysterectomy from 2010 to 2013.8 The findings demonstrated similar results to the above studies with decreased 5-year survival rates in patients with a tumor size of 2 cm or greater in the MIS group (81.3% vs 90.8; HR, 2.14; 95% CI, 1.36–3.38; P<.001). These results hold true when controlling for confounding clinical variables. Interestingly, in a subset analysis evaluating patients with tumors less than 2 cm, survival rates were similar between groups. This study confirms decreased morbidity and cost associated with MIS radical hysterectomy.
A consistent message emerges from 3 independent studies
We must take the study findings seriously and evaluate the quality of the evidence. There are many strengths to the above studies. First and most importantly, the LACC study is the only prospective randomized controlled trial (RCT) to evaluate this very important clinical question. RCTs are the gold standard for understanding the effectiveness and safety of an intervention compared with an established treatment. The study was well designed in that the study population was clearly defined with detailed inclusion and exclusion criteria. The intention to treat analysis was similar to the per-protocol analysis, and the study followed Consolidated Standards of Reporting Trials (CONSORT) guidelines. While the study was stopped early, there was still 84% power for the primary outcome. Therefore, when it comes to MIS for cervical cancer, this study provides the soundest data we have available. It is also extremely noteworthy that two additional large retrospective studies evaluating this question separately found similar results.
Criticisms remain, but older research has drawbacks
A main concern with these studies is that the findings challenge previously published research, which overall suggest similar survival outcomes between MIS and open surgical approaches. However, in evaluating the previously published retrospective data it is clear that the studies have considerable limitations.
Long-term survival not always evaluated in research. First, the majority of studies comparing MIS and open treatment modalities specifically evaluated perioperative complications and did not consider long-term survival.4,9,10 Of those studies that did consider survival outcomes, the groups often were not balanced and were skewed toward the open surgery patients having larger tumors and higher-stage disease.5
Difficult to compare “apples to apples.” These findings are complicated by the fact that open radical hysterectomies were essentially replaced by MIS radical hysterectomies, and therefore, the comparisons are not equivalent since they are comparing different treatment times. For instance, throughout the time period many of these studies were conducted, the treatment paradigm for early-stage cervical cancer changed regarding who received adjuvant therapy and imaging techniques. Therefore, these studies are not comparing apples to apples.11,12
Are we going to increase morbidity? Another common concern when considering abandoning MIS for cervical cancer is the increase in morbidity that our patients may incur immediately postoperatively due to open surgery. Multiple studies have associated minimally invasive radical hysterectomies with decreased blood loss, shorter hospital stay, lower transfusion rates, and decreased time until return of bowel function.4,10,13
Continue to: While we recognize that...
While we recognize that open surgery is associated with increased morbidity, we do argue that, with the almost-universal implementation of Enhanced Recovery Pathways (ERP) in gynecologic oncology, the disparities between the two groups will be minimized and likely are much smaller than that reported in historical literature.14 Notably, there were no differences in peri-, intra-, or postoperative complications between the two groups in the LACC study, indicating that MIS may not be saving our patients as much morbidity as we think.
Surgical ability differences. Despite the vast strengths associated with the studies we have discussed they certainly embody limitations as well. First, surgical aptitude is difficult to evaluate and tease out. This is extremely pertinent given perioperative, and postoperative, outcomes in cervical cancer, as well as survival outcomes, in multiple surgically managed cancers, which are directly associated with the volume and proficiency of the surgeon.15-19 Additionally, the mode of minimally invasive surgery that was most commonly utilized was different from practice in the United States. Eighty four percent of the patients in the MIS group of the LACC study underwent laparoscopic and 13.6% underwent robot-assisted radical hysterectomy. This is starkly different from US practice, where 75% of gynecologic oncologists report performing radical hysterectomies only robotically.20
Take-home points
Consider this latest evidence in your surgical planning. Most importantly, the evidence is the evidence. In other words, we can attempt to explain away the findings, but despite arguments against these studies, these data are the most reliable evidence we have to date regarding outcomes for cervical cancer with MIS versus open approaches. These data demonstrate that MIS may be harming our patients and so we must take this into careful consideration during surgical planning.
For small cancers, MIS may be the best option. MIS radical hysterectomy may still be the best approach for patients with tumors less than 2 cm in size. The LACC study is not powered to evaluate oncologic outcomes in this subset of patients and the two retrospective studies suggest no difference in survival in this cohort.
We must work to understand the driving force between the disparate outcomes. Are the increased rates due to the open surgical approach, the uterine manipulator, circulating CO2 gas, or tumor exposure to the intraperitoneal cavity as the authors suggest? Or is it due to surgical expertise, tumor biology, tumor size, or mode of MIS? At this point the impelling cause is unknown.
New NCCN guidelines are to come. Up to this point the National Comprehensive Cancer Network (NCCN) guidelines stated that “radical hysterectomy procedure may be performed either via laparotomy or laparoscopy.” Given these recent studies, however, new NCCN guidelines will be released cautioning the use of the MIS approach. In short, these data have transformed the standard of care.
At our institution, the majority of radical hysterectomies will be performed open. Continued discussion remains regarding small lesions, but even in these cases most surgeons will proceed with open surgery in an attempt to maximize survival.
As providers, it is our duty to honestly reflect on published data and comprehensively counsel patients about the risks and benefits associated with each approach, including the fact that recurrence may be higher with a minimally invasive approach. Patients and providers must then collectively decide what is best for each individual case.
A minimally invasive approach for gynecologic surgery increasingly has become the surgical modality of choice (vs open surgery) due to decreased perioperative and postoperative morbidity for many gynecologic cancers.1-3 This has included radical hysterectomy for cervical cancers. Until recently, retrospective evidence supported its use, suggesting decreased perioperative and postoperative complications with similar survival outcomes between patients undergoing minimally invasive and open radical hysterectomy.4,5 In November 2018, two new studies were published in the New England Journal of Medicine, and another study was presented at the American Society of Clinical Oncology (ASCO) annual meeting challenging this practice paradigm. These studies reveal a higher risk of disease recurrence and decreased overall survival with minimally invasive surgery (MIS) compared with open surgery for Stages IA–IB1 cervical cancer. These findings have resulted in a change in practice nationwide.
RCT findings astonish specialty
The first study, the Laparoscopic Approach to Cervical Cancer (LACC) trial, authored by Ramirez and colleagues was a noninferiority randomized controlled trial evaluating MIS versus open radical hysterectomy for patients with cervical cancer (Stage 1A–1B1) conducted from 2008–2017.6 The primary outcome was disease-free survival at 4.5 years. Secondary outcomes included recurrence and overall survival rates. Power analysis suggested a sample size of 740 patients to provide greater than 80% power with a noninferiority margin of -7.2% between disease-free rates of the two groups. However, the study was closed prematurely at enrollment of 631 patients (85% recruitment) by the Data Safety Monitoring Committee due to the astounding differences in survival between the two groups.
The rate of disease-free survival at 4.5 years was 86.0% with MIS and 96% with open surgery. There were 27 recurrences (8.5%) in the MIS group and only 7 (2.2%) in the open-surgery group, accounting for a hazard ratio (HR) for disease recurrence or death from cervical cancer of 3.74 (95% confidence interval [CI], 1.63–8.58). This difference remained after adjusting for confounding variables. There were 22 deaths—19 (5.9%) in the MIS group and 3 (0.1%) in the open-surgery group (HR, 6.56). Although patient characteristics between groups appeared to be similar, more than one-third of patients in each group had missing data regarding histology at the time of surgery, grade, tumor size, lymphovascular space invasion, and depth of invasion. Interestingly, intraoperative, perioperative, and postoperative complications between the two groups were similar (with rates of 11%, about 40%, and about 25%, respectively).
Surprising findings continue in NEJM
The second study, by Melamed and colleagues, was a retrospective cohort study using data from the National Cancer Database (NCDB) and the Surveillance, Epidemiology, and End Results (SEER) database evaluating women with stage IA2 or IB1 cervical cancer who underwent either minimally invasive or open radical hysterectomy between 2010 and 2013.7 The primary outcome was time to death.
Participant characteristics. A total of 2,461 women were included: 49.8% underwent MIS and 50.2% underwent open surgery. According to the raw data, patients undergoing MIS were more likely to be white, privately insured, reside in an area associated with higher income, undergo surgery at a nonacademic institution, have adenocarcinoma, and have smaller, lower-grade tumors. After propensity-score weighting, demographic and clinical characteristics were similar between groups. Median follow-up was 45 months.
Results. A total of 164 deaths occurred: 94 in the MIS and 70 in the open-surgery group. The risk of death during study follow-up was 9.1% in the MIS group versus 5.3% in the open-surgery group, and women who underwent MIS had shorter overall survival (P = .002; HR, 1.65; 95% CI, 1.22–2.22). Mortality rates remained higher in the MIS group after adjusting for adjuvant therapy (HR, 1.62; 95% CI, 1.2–2.19). However, the HR for death with MIS was not statistically significant in a subgroup analysis evaluating tumors 2 cm in size or less (HR, 1.46; 95% CI, 0.70–3.02). The authors demonstrated that the adoption of MIS for radical hysterectomy corresponded to a drop in the 4-year survival rate of 0.8% per year (P = .01).
Continue to: ASCO meeting data emphasize lower...
ASCO meeting data emphasize lower mortality and survival rates for MIS
A third important, but less publicized study, is a retrospective cohort study by Marguland and colleagues that was presented at the ASCO annual meeting and is pending publication. This study evaluated the 5-year survival of women with stage IB1 cervical cancer after MIS or open radical hysterectomy from 2010 to 2013.8 The findings demonstrated similar results to the above studies with decreased 5-year survival rates in patients with a tumor size of 2 cm or greater in the MIS group (81.3% vs 90.8; HR, 2.14; 95% CI, 1.36–3.38; P<.001). These results hold true when controlling for confounding clinical variables. Interestingly, in a subset analysis evaluating patients with tumors less than 2 cm, survival rates were similar between groups. This study confirms decreased morbidity and cost associated with MIS radical hysterectomy.
A consistent message emerges from 3 independent studies
We must take the study findings seriously and evaluate the quality of the evidence. There are many strengths to the above studies. First and most importantly, the LACC study is the only prospective randomized controlled trial (RCT) to evaluate this very important clinical question. RCTs are the gold standard for understanding the effectiveness and safety of an intervention compared with an established treatment. The study was well designed in that the study population was clearly defined with detailed inclusion and exclusion criteria. The intention to treat analysis was similar to the per-protocol analysis, and the study followed Consolidated Standards of Reporting Trials (CONSORT) guidelines. While the study was stopped early, there was still 84% power for the primary outcome. Therefore, when it comes to MIS for cervical cancer, this study provides the soundest data we have available. It is also extremely noteworthy that two additional large retrospective studies evaluating this question separately found similar results.
Criticisms remain, but older research has drawbacks
A main concern with these studies is that the findings challenge previously published research, which overall suggest similar survival outcomes between MIS and open surgical approaches. However, in evaluating the previously published retrospective data it is clear that the studies have considerable limitations.
Long-term survival not always evaluated in research. First, the majority of studies comparing MIS and open treatment modalities specifically evaluated perioperative complications and did not consider long-term survival.4,9,10 Of those studies that did consider survival outcomes, the groups often were not balanced and were skewed toward the open surgery patients having larger tumors and higher-stage disease.5
Difficult to compare “apples to apples.” These findings are complicated by the fact that open radical hysterectomies were essentially replaced by MIS radical hysterectomies, and therefore, the comparisons are not equivalent since they are comparing different treatment times. For instance, throughout the time period many of these studies were conducted, the treatment paradigm for early-stage cervical cancer changed regarding who received adjuvant therapy and imaging techniques. Therefore, these studies are not comparing apples to apples.11,12
Are we going to increase morbidity? Another common concern when considering abandoning MIS for cervical cancer is the increase in morbidity that our patients may incur immediately postoperatively due to open surgery. Multiple studies have associated minimally invasive radical hysterectomies with decreased blood loss, shorter hospital stay, lower transfusion rates, and decreased time until return of bowel function.4,10,13
Continue to: While we recognize that...
While we recognize that open surgery is associated with increased morbidity, we do argue that, with the almost-universal implementation of Enhanced Recovery Pathways (ERP) in gynecologic oncology, the disparities between the two groups will be minimized and likely are much smaller than that reported in historical literature.14 Notably, there were no differences in peri-, intra-, or postoperative complications between the two groups in the LACC study, indicating that MIS may not be saving our patients as much morbidity as we think.
Surgical ability differences. Despite the vast strengths associated with the studies we have discussed they certainly embody limitations as well. First, surgical aptitude is difficult to evaluate and tease out. This is extremely pertinent given perioperative, and postoperative, outcomes in cervical cancer, as well as survival outcomes, in multiple surgically managed cancers, which are directly associated with the volume and proficiency of the surgeon.15-19 Additionally, the mode of minimally invasive surgery that was most commonly utilized was different from practice in the United States. Eighty four percent of the patients in the MIS group of the LACC study underwent laparoscopic and 13.6% underwent robot-assisted radical hysterectomy. This is starkly different from US practice, where 75% of gynecologic oncologists report performing radical hysterectomies only robotically.20
Take-home points
Consider this latest evidence in your surgical planning. Most importantly, the evidence is the evidence. In other words, we can attempt to explain away the findings, but despite arguments against these studies, these data are the most reliable evidence we have to date regarding outcomes for cervical cancer with MIS versus open approaches. These data demonstrate that MIS may be harming our patients and so we must take this into careful consideration during surgical planning.
For small cancers, MIS may be the best option. MIS radical hysterectomy may still be the best approach for patients with tumors less than 2 cm in size. The LACC study is not powered to evaluate oncologic outcomes in this subset of patients and the two retrospective studies suggest no difference in survival in this cohort.
We must work to understand the driving force between the disparate outcomes. Are the increased rates due to the open surgical approach, the uterine manipulator, circulating CO2 gas, or tumor exposure to the intraperitoneal cavity as the authors suggest? Or is it due to surgical expertise, tumor biology, tumor size, or mode of MIS? At this point the impelling cause is unknown.
New NCCN guidelines are to come. Up to this point the National Comprehensive Cancer Network (NCCN) guidelines stated that “radical hysterectomy procedure may be performed either via laparotomy or laparoscopy.” Given these recent studies, however, new NCCN guidelines will be released cautioning the use of the MIS approach. In short, these data have transformed the standard of care.
At our institution, the majority of radical hysterectomies will be performed open. Continued discussion remains regarding small lesions, but even in these cases most surgeons will proceed with open surgery in an attempt to maximize survival.
As providers, it is our duty to honestly reflect on published data and comprehensively counsel patients about the risks and benefits associated with each approach, including the fact that recurrence may be higher with a minimally invasive approach. Patients and providers must then collectively decide what is best for each individual case.
- Walker JL, Piedmonte MR, Spirtos NM, et al. Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study LAP2. J Clin Oncol. 2009;27:5331-5336.
- Zanagnolo V, Minig L, Rollo D, et al. Clinical and oncologic outcomes of robotic versus abdominal radical hysterectomy for women with cervical cancer: experience at a referral cancer center. Int J Gynecol Cancer. 2016;26:568-574.
- Wallin E, Floter Radestad A, et al. Introduction of robot-assisted radical hysterectomy for early stage cervical cancer: impact on complications, costs and oncologic outcome. Acta Obstet Gynecol Scand. 2017;96:536-542.
- Sert BM, Boggess JF, Ahmad S, et al. Robot-assisted versus open radical hysterectomy: a multi-institutional experience for early-stage cervical cancer. Euro J Surg Oncol. 2016;42:513-522.
- Shah CA, Beck T, Liao JB, et al. Surgical and oncologic outcomes after robotic radical hysterectomy as compared to open radical hysterectomy in the treatment of early cervical cancer. J Gynecol Oncol. 2017;28:e82.
- Ramirez PT, Frumovitz M, Pareja R, et al. Minimally invasive versus abdominal radical hysterectomy for cervical cancer. N Engl J Med. 2018;379:1895-1904.
- Melamed A, Margul DJ, Chen L, et al. Survival after minimally invasive radical hysterectomy for early stage cervical cancer. N Engl J Med. 2018;379:1905-1914.
- Margul DJ, Yang J, Seagle BL, et al. Outcomes and costs of open, robotic, and laparoscopic radical hysterectomy for stage IB1 cervical cancer. J Clin Oncol. 2018;36(15 suppl):5502.
- Geetha P, Nair MK. Laparoscopic, robotic and open method of radical hysterectomy for cervical cancer: a systematic review. J Minim Access Surg. 2012;8:67-73.
- Jin YM, Liu SS, Chen J, et al. Robotic radical hysterectomy is superior to laparoscopic radical hysterectomy and open radical hysterectomy in the treatment of cervical cancer. PloS One. 2018;13:e0193033.
- Rotman M, Sedlis A, Piedmonte MR, et al. A phase III randomized trial of postoperative pelvic irradiation in Stage IB cervical carcinoma with poor prognostic features: follow-up of a gynecologic oncology group study. Int J Radiation Oncol, Biol, Phys. 2006;65:169-176.
- Peters WA 3rd, Liu PY, Barrett RJ 2nd, et al. Concurrent chemotherapy and pelvic radiation therapy compared with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cancer of the cervix. J Clin Oncol. 2000;18:1606-1613.
- Uppal S, Liu RJ, Reynolds KR, et al. Trends and comparative effectiveness of inpatient radical hysterectomy for cervical cancer in the United States (2012-2015). Gynecol Oncol. 2018. pii: S0090-8258(18)31246-0.
- Barber EL, Van Le L. Enhanced Recovery Pathways in Gynecology and Gynecologic Oncology. Obstetr Gynecol Surv. 2015;70:780-792.
- Morche J, Mathes T, Pieper D. Relationship between surgeon volume and outcomes: a systematic review of systematic reviews. Syst Rev. 2016;5:204.
- Persson J, Reynisson P, Borgfeldt C, et al. Robot assisted laparoscopic radical hysterectomy and pelvic lymphadenectomy with short and long term morbidity data. Gynecol Oncol. 2009;113:185-190.
- Woelk JL, Casiano ER, Weaver AL, et al. The learning curve of robotic hysterectomy. Obstetr Gynecol. 2013;121:87-95.
- Yim GW, Kim SW, Nam EJ, et al. Learning curve analysis of robot-assisted radical hysterectomy for cervical cancer: initial experience at a single institution. J Gynecol Oncol. 2013;24:303-312.
- Vickers AJ, Bianco FJ, Serio AM, et al. The surgical learning curve for prostate cancer control after radical prostatectomy. J Natl Can Inst. 2007;99:1171-1177.
- Conrad LB, Ramirez PT, Burke W, et al. Role of minimally invasive surgery in gynecologic oncology: an updated survey of members of the Society of Gynecologic Oncology. Int J Gynecol Cancer. 2015;25:1121-1127.
- Walker JL, Piedmonte MR, Spirtos NM, et al. Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study LAP2. J Clin Oncol. 2009;27:5331-5336.
- Zanagnolo V, Minig L, Rollo D, et al. Clinical and oncologic outcomes of robotic versus abdominal radical hysterectomy for women with cervical cancer: experience at a referral cancer center. Int J Gynecol Cancer. 2016;26:568-574.
- Wallin E, Floter Radestad A, et al. Introduction of robot-assisted radical hysterectomy for early stage cervical cancer: impact on complications, costs and oncologic outcome. Acta Obstet Gynecol Scand. 2017;96:536-542.
- Sert BM, Boggess JF, Ahmad S, et al. Robot-assisted versus open radical hysterectomy: a multi-institutional experience for early-stage cervical cancer. Euro J Surg Oncol. 2016;42:513-522.
- Shah CA, Beck T, Liao JB, et al. Surgical and oncologic outcomes after robotic radical hysterectomy as compared to open radical hysterectomy in the treatment of early cervical cancer. J Gynecol Oncol. 2017;28:e82.
- Ramirez PT, Frumovitz M, Pareja R, et al. Minimally invasive versus abdominal radical hysterectomy for cervical cancer. N Engl J Med. 2018;379:1895-1904.
- Melamed A, Margul DJ, Chen L, et al. Survival after minimally invasive radical hysterectomy for early stage cervical cancer. N Engl J Med. 2018;379:1905-1914.
- Margul DJ, Yang J, Seagle BL, et al. Outcomes and costs of open, robotic, and laparoscopic radical hysterectomy for stage IB1 cervical cancer. J Clin Oncol. 2018;36(15 suppl):5502.
- Geetha P, Nair MK. Laparoscopic, robotic and open method of radical hysterectomy for cervical cancer: a systematic review. J Minim Access Surg. 2012;8:67-73.
- Jin YM, Liu SS, Chen J, et al. Robotic radical hysterectomy is superior to laparoscopic radical hysterectomy and open radical hysterectomy in the treatment of cervical cancer. PloS One. 2018;13:e0193033.
- Rotman M, Sedlis A, Piedmonte MR, et al. A phase III randomized trial of postoperative pelvic irradiation in Stage IB cervical carcinoma with poor prognostic features: follow-up of a gynecologic oncology group study. Int J Radiation Oncol, Biol, Phys. 2006;65:169-176.
- Peters WA 3rd, Liu PY, Barrett RJ 2nd, et al. Concurrent chemotherapy and pelvic radiation therapy compared with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cancer of the cervix. J Clin Oncol. 2000;18:1606-1613.
- Uppal S, Liu RJ, Reynolds KR, et al. Trends and comparative effectiveness of inpatient radical hysterectomy for cervical cancer in the United States (2012-2015). Gynecol Oncol. 2018. pii: S0090-8258(18)31246-0.
- Barber EL, Van Le L. Enhanced Recovery Pathways in Gynecology and Gynecologic Oncology. Obstetr Gynecol Surv. 2015;70:780-792.
- Morche J, Mathes T, Pieper D. Relationship between surgeon volume and outcomes: a systematic review of systematic reviews. Syst Rev. 2016;5:204.
- Persson J, Reynisson P, Borgfeldt C, et al. Robot assisted laparoscopic radical hysterectomy and pelvic lymphadenectomy with short and long term morbidity data. Gynecol Oncol. 2009;113:185-190.
- Woelk JL, Casiano ER, Weaver AL, et al. The learning curve of robotic hysterectomy. Obstetr Gynecol. 2013;121:87-95.
- Yim GW, Kim SW, Nam EJ, et al. Learning curve analysis of robot-assisted radical hysterectomy for cervical cancer: initial experience at a single institution. J Gynecol Oncol. 2013;24:303-312.
- Vickers AJ, Bianco FJ, Serio AM, et al. The surgical learning curve for prostate cancer control after radical prostatectomy. J Natl Can Inst. 2007;99:1171-1177.
- Conrad LB, Ramirez PT, Burke W, et al. Role of minimally invasive surgery in gynecologic oncology: an updated survey of members of the Society of Gynecologic Oncology. Int J Gynecol Cancer. 2015;25:1121-1127.
Don’t leave vaginal hysterectomies behind, surgeon urges
LAS VEGAS –
While “younger trainees are seeing fewer vaginal procedures being done and have less confidence to do the procedure,” research suggests that the vaginal approach can offer major benefits, compared with the alternatives, Rosanne M. Kho, MD, of the Cleveland Clinic, said at the Pelvic Anatomy and Gynecologic Surgery Symposium.
Dr. Kho pointed to several studies suggesting a decline in vaginal hysterectomies as laparoscopic and robot procedures become more common. One study compared hysterectomy surgery approaches during 2007-2010 and found a sharp rise in robotic procedures (0.5% to 10%) and a big decrease in abdominal procedures (from 54% to 40%). The rate of laparoscopic procedures grew (from 24% to 30%), while vaginal procedures dipped slightly (22% to 20%) (JAMA. 2013 Feb 20;309[7]:689-98). Another study tracked hysterectomy strategies at Pittsburgh’s Magee-Womens Hospital in almost 14,000 women during 2000-2010. It found that vaginal hysterectomy rates fell from 22% to 17% while laparoscopic rates grew remarkably from 3% to 43%. Open procedures fell dramatically from 75% to 36% (Am J Obstet Gynecol. 2013 Apr. doi: 10.1016/j.ajog.2013.01.022).
These findings are “telling me that surgeons are steering away from the vaginal approach because the laparoscopic and robotic approach are much more appealing,” Dr. Koh said at the meeting, which was jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.
Specifically, it appears that surgeons think the vaginal hysterectomy is more “challenging” and “cumbersome,” Dr. Kho said, and they lack inadequate training.
Why should vaginal hysterectomy still be considered? Dr. Kho pointed to two pieces of evidence:
- Expert opinion. A 2017 committee opinion from the American College of Obstetricians and Gynecologists examined routes of hysterectomy in benign disease and declared that, despite the decrease in its use, “evidence supports the opinion that [when feasible] vaginal hysterectomy is associated with better outcomes” than are laparoscopic or abdominal hysterectomy. Also, the decision to perform a salpingo-oophorectomy is not necessarily a contraindication to performing a vaginal hysterectomy, according to the committee opinion (Obstet Gynecol. 2017 Jun;129[6]:e155-e9).The opinion also says, “the vaginal approach is preferred among the minimally invasive approaches. Laparoscopic hysterectomy is a preferable alternative to open abdominal hysterectomy for those patients in whom a vaginal hysterectomy is not indicated or feasible. Although minimally invasive approaches to hysterectomy are the preferred route, open abdominal hysterectomy remains an important surgical option for some patients.”
- Randomized, controlled studies. A 2015 Cochrane Library systematic review examined 47 randomized, controlled trials and found that “vaginal hysterectomy should be performed whenever possible. Where vaginal hysterectomy is not possible, both a laparoscopic approach and abdominal hysterectomy have their pros and cons, and these should be incorporated in the decision-making process” (Cochrane Database Syst Rev. 2015 Aug 12. doi: 10.1002/14651858.CD003677.pub5).
What if a patient has an enlarged uterus? Dr. Kho coauthored a 2017 review that suggested that vaginal hysterectomy may be appropriate in this case. Her report found that in women with large uteri, “vaginal hysterectomy is preferred over laparoscopic and laparoscopic assistance with less operative time and hospital cost. In morbidly obese patients with large uteri, total laparoscopic hysterectomy is superior to vaginal hysterectomy with lesser odds of blood transfusion and lower length of hospital stay” (Clin Obstet Gynecol. 2017 Jun;60[2]:286-95).
What about the removal of fallopian tubes – salpingectomy – during vaginal hysterectomy? Dr. Kho highlighted a 2017 decision analysis that said these procedures are frequently performed for cancer prevention during laparoscopic and open hysterectomies “but [fallopian tubes] are not routinely removed during vaginal hysterectomy because of perceptions of increased morbidity, difficulty, or inadequate surgical training.”
The analysis, however, determined that “salpingectomy should routinely be performed with vaginal hysterectomy because it was the dominant and therefore cost-effective strategy. Complications are minimally increased, but the trade-off with cancer prevention is highly favorable.” (Am J Obstet Gynecol. 2017 Nov;217[5]:603.e1-603.e6).
Dr. Kho reported consulting for AbbVie, Olympus, and Applied Medical.
LAS VEGAS –
While “younger trainees are seeing fewer vaginal procedures being done and have less confidence to do the procedure,” research suggests that the vaginal approach can offer major benefits, compared with the alternatives, Rosanne M. Kho, MD, of the Cleveland Clinic, said at the Pelvic Anatomy and Gynecologic Surgery Symposium.
Dr. Kho pointed to several studies suggesting a decline in vaginal hysterectomies as laparoscopic and robot procedures become more common. One study compared hysterectomy surgery approaches during 2007-2010 and found a sharp rise in robotic procedures (0.5% to 10%) and a big decrease in abdominal procedures (from 54% to 40%). The rate of laparoscopic procedures grew (from 24% to 30%), while vaginal procedures dipped slightly (22% to 20%) (JAMA. 2013 Feb 20;309[7]:689-98). Another study tracked hysterectomy strategies at Pittsburgh’s Magee-Womens Hospital in almost 14,000 women during 2000-2010. It found that vaginal hysterectomy rates fell from 22% to 17% while laparoscopic rates grew remarkably from 3% to 43%. Open procedures fell dramatically from 75% to 36% (Am J Obstet Gynecol. 2013 Apr. doi: 10.1016/j.ajog.2013.01.022).
These findings are “telling me that surgeons are steering away from the vaginal approach because the laparoscopic and robotic approach are much more appealing,” Dr. Koh said at the meeting, which was jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.
Specifically, it appears that surgeons think the vaginal hysterectomy is more “challenging” and “cumbersome,” Dr. Kho said, and they lack inadequate training.
Why should vaginal hysterectomy still be considered? Dr. Kho pointed to two pieces of evidence:
- Expert opinion. A 2017 committee opinion from the American College of Obstetricians and Gynecologists examined routes of hysterectomy in benign disease and declared that, despite the decrease in its use, “evidence supports the opinion that [when feasible] vaginal hysterectomy is associated with better outcomes” than are laparoscopic or abdominal hysterectomy. Also, the decision to perform a salpingo-oophorectomy is not necessarily a contraindication to performing a vaginal hysterectomy, according to the committee opinion (Obstet Gynecol. 2017 Jun;129[6]:e155-e9).The opinion also says, “the vaginal approach is preferred among the minimally invasive approaches. Laparoscopic hysterectomy is a preferable alternative to open abdominal hysterectomy for those patients in whom a vaginal hysterectomy is not indicated or feasible. Although minimally invasive approaches to hysterectomy are the preferred route, open abdominal hysterectomy remains an important surgical option for some patients.”
- Randomized, controlled studies. A 2015 Cochrane Library systematic review examined 47 randomized, controlled trials and found that “vaginal hysterectomy should be performed whenever possible. Where vaginal hysterectomy is not possible, both a laparoscopic approach and abdominal hysterectomy have their pros and cons, and these should be incorporated in the decision-making process” (Cochrane Database Syst Rev. 2015 Aug 12. doi: 10.1002/14651858.CD003677.pub5).
What if a patient has an enlarged uterus? Dr. Kho coauthored a 2017 review that suggested that vaginal hysterectomy may be appropriate in this case. Her report found that in women with large uteri, “vaginal hysterectomy is preferred over laparoscopic and laparoscopic assistance with less operative time and hospital cost. In morbidly obese patients with large uteri, total laparoscopic hysterectomy is superior to vaginal hysterectomy with lesser odds of blood transfusion and lower length of hospital stay” (Clin Obstet Gynecol. 2017 Jun;60[2]:286-95).
What about the removal of fallopian tubes – salpingectomy – during vaginal hysterectomy? Dr. Kho highlighted a 2017 decision analysis that said these procedures are frequently performed for cancer prevention during laparoscopic and open hysterectomies “but [fallopian tubes] are not routinely removed during vaginal hysterectomy because of perceptions of increased morbidity, difficulty, or inadequate surgical training.”
The analysis, however, determined that “salpingectomy should routinely be performed with vaginal hysterectomy because it was the dominant and therefore cost-effective strategy. Complications are minimally increased, but the trade-off with cancer prevention is highly favorable.” (Am J Obstet Gynecol. 2017 Nov;217[5]:603.e1-603.e6).
Dr. Kho reported consulting for AbbVie, Olympus, and Applied Medical.
LAS VEGAS –
While “younger trainees are seeing fewer vaginal procedures being done and have less confidence to do the procedure,” research suggests that the vaginal approach can offer major benefits, compared with the alternatives, Rosanne M. Kho, MD, of the Cleveland Clinic, said at the Pelvic Anatomy and Gynecologic Surgery Symposium.
Dr. Kho pointed to several studies suggesting a decline in vaginal hysterectomies as laparoscopic and robot procedures become more common. One study compared hysterectomy surgery approaches during 2007-2010 and found a sharp rise in robotic procedures (0.5% to 10%) and a big decrease in abdominal procedures (from 54% to 40%). The rate of laparoscopic procedures grew (from 24% to 30%), while vaginal procedures dipped slightly (22% to 20%) (JAMA. 2013 Feb 20;309[7]:689-98). Another study tracked hysterectomy strategies at Pittsburgh’s Magee-Womens Hospital in almost 14,000 women during 2000-2010. It found that vaginal hysterectomy rates fell from 22% to 17% while laparoscopic rates grew remarkably from 3% to 43%. Open procedures fell dramatically from 75% to 36% (Am J Obstet Gynecol. 2013 Apr. doi: 10.1016/j.ajog.2013.01.022).
These findings are “telling me that surgeons are steering away from the vaginal approach because the laparoscopic and robotic approach are much more appealing,” Dr. Koh said at the meeting, which was jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.
Specifically, it appears that surgeons think the vaginal hysterectomy is more “challenging” and “cumbersome,” Dr. Kho said, and they lack inadequate training.
Why should vaginal hysterectomy still be considered? Dr. Kho pointed to two pieces of evidence:
- Expert opinion. A 2017 committee opinion from the American College of Obstetricians and Gynecologists examined routes of hysterectomy in benign disease and declared that, despite the decrease in its use, “evidence supports the opinion that [when feasible] vaginal hysterectomy is associated with better outcomes” than are laparoscopic or abdominal hysterectomy. Also, the decision to perform a salpingo-oophorectomy is not necessarily a contraindication to performing a vaginal hysterectomy, according to the committee opinion (Obstet Gynecol. 2017 Jun;129[6]:e155-e9).The opinion also says, “the vaginal approach is preferred among the minimally invasive approaches. Laparoscopic hysterectomy is a preferable alternative to open abdominal hysterectomy for those patients in whom a vaginal hysterectomy is not indicated or feasible. Although minimally invasive approaches to hysterectomy are the preferred route, open abdominal hysterectomy remains an important surgical option for some patients.”
- Randomized, controlled studies. A 2015 Cochrane Library systematic review examined 47 randomized, controlled trials and found that “vaginal hysterectomy should be performed whenever possible. Where vaginal hysterectomy is not possible, both a laparoscopic approach and abdominal hysterectomy have their pros and cons, and these should be incorporated in the decision-making process” (Cochrane Database Syst Rev. 2015 Aug 12. doi: 10.1002/14651858.CD003677.pub5).
What if a patient has an enlarged uterus? Dr. Kho coauthored a 2017 review that suggested that vaginal hysterectomy may be appropriate in this case. Her report found that in women with large uteri, “vaginal hysterectomy is preferred over laparoscopic and laparoscopic assistance with less operative time and hospital cost. In morbidly obese patients with large uteri, total laparoscopic hysterectomy is superior to vaginal hysterectomy with lesser odds of blood transfusion and lower length of hospital stay” (Clin Obstet Gynecol. 2017 Jun;60[2]:286-95).
What about the removal of fallopian tubes – salpingectomy – during vaginal hysterectomy? Dr. Kho highlighted a 2017 decision analysis that said these procedures are frequently performed for cancer prevention during laparoscopic and open hysterectomies “but [fallopian tubes] are not routinely removed during vaginal hysterectomy because of perceptions of increased morbidity, difficulty, or inadequate surgical training.”
The analysis, however, determined that “salpingectomy should routinely be performed with vaginal hysterectomy because it was the dominant and therefore cost-effective strategy. Complications are minimally increased, but the trade-off with cancer prevention is highly favorable.” (Am J Obstet Gynecol. 2017 Nov;217[5]:603.e1-603.e6).
Dr. Kho reported consulting for AbbVie, Olympus, and Applied Medical.
EXPERT ANALYSIS FROM PAGS
Black women more likely to have open hysterectomies
Black women were more likely than white women to undergo open hysterectomy, according to a recent analysis of national surgical data by Amy L. Alexander, MD, MS, of Northwestern University, Chicago, and her colleagues.
Even after the researchers controlled for many factors that might influence surgical approach, such as comorbidities and body mass index, black women had an odds ratio of 2.02 to receive open, rather than laparoscopic, hysterectomy (95% confidence interval, 1.85-2.20), according to a study in Obstetrics & Gynecology.
The analysis of the targeted hysterectomy file in the National Surgical Quality Improvement Program (NSQIP) database showed that, of 15,316 women who had hysterectomy for nonmalignant indications, the 25% who were black also were more likely to have major complications with open procedures. Such complications as sepsis, wound dehiscence, prolonged intubation, and death were seen in 4% of the black women, versus 2% of the white women receiving open hysterectomy (P less than .001). Minor complications, such as urinary tract infections, superficial wound infections, and blood transfusions, also were more common for black women having open procedures (11% vs. 7%; P less than .001).
The study used a large national database with detailed information about comorbidities and patient characteristics to look at racial disparities in surgical route and complications for the second-most-common surgical procedure women receive on the United States. The results, said Dr. Alexander and her coauthors, confirm and extend previous work showing these disparities.
Black women are known to have more diabetes and hypertension, as well as higher rates of obesity, compared with white women, wrote Dr. Alexander and her coauthors. Even after they controlled for all these variables, black women still had significantly higher odds of having complications from hysterectomy: The odds ratios for major and minor complications were 1.56 and 1.27, respectively.
Uterine weight was included and tracked as a binary variable, with large uteri considered those weighing 250 g or more. Making uterine weight a binary, rather than continuous or categorical variable, didn’t significantly change results, and realistically mirrors a surgeon’s assessment of a uterus as “large” or “small” when making treatment decisions, Dr. Alexander and her coauthors said.
Because the median weight of uteri from black women was more than double the weight of those from white women (262 g vs. 123 g), the investigators also performed an analysis looking just at women with uterine weight less than 250 g, to ensure that uterine weight alone was not accounting for much of the disparity. In this analysis, the black patients still had an adjusted odds ratio of 1.84 for receiving an open procedure.
“Some of the postoperative complications experienced by black women are likely attributable to the fact that black women are more likely to undergo an open hysterectomy,” noted Dr. Alexander and her colleagues. “However, because black race is still associated with a higher odds of complications, even when adjusting for hysterectomy route, there are other contributing factors that warrant further investigation.” Among these factors, they said, may be access to care and quality of care while hospitalized.
The study’s strengths include the use of the NSQIP database’s prospectively collected data to construct the cohort study; the data base included “important patient-level factors such as uterine size, obesity, and comorbidities not previously available in other secondary data set studies,” noted Dr. Alexander and her colleagues. But the possibility of unmeasured bias persists, they said, and such variables as regional practice patterns and surgeon experience and procedure volume could not be detected from the NSQIP data on hand.
“This study suggests that an important step to reduce the disparity in route of surgery and postoperative complications is to increase access to and use of minimally invasive surgery,” wrote Dr. Alexander and her coauthors.
The study was funded by the National Institutes of Health. Dr. Alexander and her colleagues reported no conflicts of interest.
koakes@mdedge.com
SOURCE: Alexander AL et al. Obstet Gynecol. 2018 Dec 4. doi: 10.1097/AOG.0000000000002990
The discrepancies reported by Dr. Alexander and her colleagues between black and white women undergoing hysterectomy for nonmalignant reasons mirror discrepancies found for other oncologic procedures, including colectomy and prostatectomy.
Findings of the current study show that black women continue to be less likely to receive more modern, minimally invasive procedures, and that outcomes are worse for these women, even after controlling for factors that may contribute to complications.
The American College of Obstetricians and Gynecologists (ACOG) has looked at this issue. In a 2015 opinion, an ACOG committee looked at three categories of factors contributing to racial disparities in women’s health care. Patient-level factors include such things as genetics, medical comorbidities, and patient preferences and adherence. Health care system–level factors include insurance status and geographic barriers to accessing care, while stereotyping and implicit bias on the part of practitioners constitute the third set of factors.
All these factors are likely in play for the discrepancies seen in hysterectomy rates. Those who care for black women need to understand the long, shameful history of how black Americans were mistreated, undertreated, and used for medical experimentation without consent. This past shapes present care and contributes to the difficulty black patients have trusting today’s health care systems.
The important question today is how individual health care providers will address their own biases, learn from the past, and move forward to do better for our black patients.
Shanna N. Wingo, MD , is an ob.gyn. and a gynecologic oncologist in private practice in Phoenix. She had no potential conflicts of interest. These remarks were drawn from an editorial accompanying the study by Dr. Alexander et al.( Obstet Gynecol. 2018 Dec 4;133[1]:4-5 ).
The discrepancies reported by Dr. Alexander and her colleagues between black and white women undergoing hysterectomy for nonmalignant reasons mirror discrepancies found for other oncologic procedures, including colectomy and prostatectomy.
Findings of the current study show that black women continue to be less likely to receive more modern, minimally invasive procedures, and that outcomes are worse for these women, even after controlling for factors that may contribute to complications.
The American College of Obstetricians and Gynecologists (ACOG) has looked at this issue. In a 2015 opinion, an ACOG committee looked at three categories of factors contributing to racial disparities in women’s health care. Patient-level factors include such things as genetics, medical comorbidities, and patient preferences and adherence. Health care system–level factors include insurance status and geographic barriers to accessing care, while stereotyping and implicit bias on the part of practitioners constitute the third set of factors.
All these factors are likely in play for the discrepancies seen in hysterectomy rates. Those who care for black women need to understand the long, shameful history of how black Americans were mistreated, undertreated, and used for medical experimentation without consent. This past shapes present care and contributes to the difficulty black patients have trusting today’s health care systems.
The important question today is how individual health care providers will address their own biases, learn from the past, and move forward to do better for our black patients.
Shanna N. Wingo, MD , is an ob.gyn. and a gynecologic oncologist in private practice in Phoenix. She had no potential conflicts of interest. These remarks were drawn from an editorial accompanying the study by Dr. Alexander et al.( Obstet Gynecol. 2018 Dec 4;133[1]:4-5 ).
The discrepancies reported by Dr. Alexander and her colleagues between black and white women undergoing hysterectomy for nonmalignant reasons mirror discrepancies found for other oncologic procedures, including colectomy and prostatectomy.
Findings of the current study show that black women continue to be less likely to receive more modern, minimally invasive procedures, and that outcomes are worse for these women, even after controlling for factors that may contribute to complications.
The American College of Obstetricians and Gynecologists (ACOG) has looked at this issue. In a 2015 opinion, an ACOG committee looked at three categories of factors contributing to racial disparities in women’s health care. Patient-level factors include such things as genetics, medical comorbidities, and patient preferences and adherence. Health care system–level factors include insurance status and geographic barriers to accessing care, while stereotyping and implicit bias on the part of practitioners constitute the third set of factors.
All these factors are likely in play for the discrepancies seen in hysterectomy rates. Those who care for black women need to understand the long, shameful history of how black Americans were mistreated, undertreated, and used for medical experimentation without consent. This past shapes present care and contributes to the difficulty black patients have trusting today’s health care systems.
The important question today is how individual health care providers will address their own biases, learn from the past, and move forward to do better for our black patients.
Shanna N. Wingo, MD , is an ob.gyn. and a gynecologic oncologist in private practice in Phoenix. She had no potential conflicts of interest. These remarks were drawn from an editorial accompanying the study by Dr. Alexander et al.( Obstet Gynecol. 2018 Dec 4;133[1]:4-5 ).
Black women were more likely than white women to undergo open hysterectomy, according to a recent analysis of national surgical data by Amy L. Alexander, MD, MS, of Northwestern University, Chicago, and her colleagues.
Even after the researchers controlled for many factors that might influence surgical approach, such as comorbidities and body mass index, black women had an odds ratio of 2.02 to receive open, rather than laparoscopic, hysterectomy (95% confidence interval, 1.85-2.20), according to a study in Obstetrics & Gynecology.
The analysis of the targeted hysterectomy file in the National Surgical Quality Improvement Program (NSQIP) database showed that, of 15,316 women who had hysterectomy for nonmalignant indications, the 25% who were black also were more likely to have major complications with open procedures. Such complications as sepsis, wound dehiscence, prolonged intubation, and death were seen in 4% of the black women, versus 2% of the white women receiving open hysterectomy (P less than .001). Minor complications, such as urinary tract infections, superficial wound infections, and blood transfusions, also were more common for black women having open procedures (11% vs. 7%; P less than .001).
The study used a large national database with detailed information about comorbidities and patient characteristics to look at racial disparities in surgical route and complications for the second-most-common surgical procedure women receive on the United States. The results, said Dr. Alexander and her coauthors, confirm and extend previous work showing these disparities.
Black women are known to have more diabetes and hypertension, as well as higher rates of obesity, compared with white women, wrote Dr. Alexander and her coauthors. Even after they controlled for all these variables, black women still had significantly higher odds of having complications from hysterectomy: The odds ratios for major and minor complications were 1.56 and 1.27, respectively.
Uterine weight was included and tracked as a binary variable, with large uteri considered those weighing 250 g or more. Making uterine weight a binary, rather than continuous or categorical variable, didn’t significantly change results, and realistically mirrors a surgeon’s assessment of a uterus as “large” or “small” when making treatment decisions, Dr. Alexander and her coauthors said.
Because the median weight of uteri from black women was more than double the weight of those from white women (262 g vs. 123 g), the investigators also performed an analysis looking just at women with uterine weight less than 250 g, to ensure that uterine weight alone was not accounting for much of the disparity. In this analysis, the black patients still had an adjusted odds ratio of 1.84 for receiving an open procedure.
“Some of the postoperative complications experienced by black women are likely attributable to the fact that black women are more likely to undergo an open hysterectomy,” noted Dr. Alexander and her colleagues. “However, because black race is still associated with a higher odds of complications, even when adjusting for hysterectomy route, there are other contributing factors that warrant further investigation.” Among these factors, they said, may be access to care and quality of care while hospitalized.
The study’s strengths include the use of the NSQIP database’s prospectively collected data to construct the cohort study; the data base included “important patient-level factors such as uterine size, obesity, and comorbidities not previously available in other secondary data set studies,” noted Dr. Alexander and her colleagues. But the possibility of unmeasured bias persists, they said, and such variables as regional practice patterns and surgeon experience and procedure volume could not be detected from the NSQIP data on hand.
“This study suggests that an important step to reduce the disparity in route of surgery and postoperative complications is to increase access to and use of minimally invasive surgery,” wrote Dr. Alexander and her coauthors.
The study was funded by the National Institutes of Health. Dr. Alexander and her colleagues reported no conflicts of interest.
koakes@mdedge.com
SOURCE: Alexander AL et al. Obstet Gynecol. 2018 Dec 4. doi: 10.1097/AOG.0000000000002990
Black women were more likely than white women to undergo open hysterectomy, according to a recent analysis of national surgical data by Amy L. Alexander, MD, MS, of Northwestern University, Chicago, and her colleagues.
Even after the researchers controlled for many factors that might influence surgical approach, such as comorbidities and body mass index, black women had an odds ratio of 2.02 to receive open, rather than laparoscopic, hysterectomy (95% confidence interval, 1.85-2.20), according to a study in Obstetrics & Gynecology.
The analysis of the targeted hysterectomy file in the National Surgical Quality Improvement Program (NSQIP) database showed that, of 15,316 women who had hysterectomy for nonmalignant indications, the 25% who were black also were more likely to have major complications with open procedures. Such complications as sepsis, wound dehiscence, prolonged intubation, and death were seen in 4% of the black women, versus 2% of the white women receiving open hysterectomy (P less than .001). Minor complications, such as urinary tract infections, superficial wound infections, and blood transfusions, also were more common for black women having open procedures (11% vs. 7%; P less than .001).
The study used a large national database with detailed information about comorbidities and patient characteristics to look at racial disparities in surgical route and complications for the second-most-common surgical procedure women receive on the United States. The results, said Dr. Alexander and her coauthors, confirm and extend previous work showing these disparities.
Black women are known to have more diabetes and hypertension, as well as higher rates of obesity, compared with white women, wrote Dr. Alexander and her coauthors. Even after they controlled for all these variables, black women still had significantly higher odds of having complications from hysterectomy: The odds ratios for major and minor complications were 1.56 and 1.27, respectively.
Uterine weight was included and tracked as a binary variable, with large uteri considered those weighing 250 g or more. Making uterine weight a binary, rather than continuous or categorical variable, didn’t significantly change results, and realistically mirrors a surgeon’s assessment of a uterus as “large” or “small” when making treatment decisions, Dr. Alexander and her coauthors said.
Because the median weight of uteri from black women was more than double the weight of those from white women (262 g vs. 123 g), the investigators also performed an analysis looking just at women with uterine weight less than 250 g, to ensure that uterine weight alone was not accounting for much of the disparity. In this analysis, the black patients still had an adjusted odds ratio of 1.84 for receiving an open procedure.
“Some of the postoperative complications experienced by black women are likely attributable to the fact that black women are more likely to undergo an open hysterectomy,” noted Dr. Alexander and her colleagues. “However, because black race is still associated with a higher odds of complications, even when adjusting for hysterectomy route, there are other contributing factors that warrant further investigation.” Among these factors, they said, may be access to care and quality of care while hospitalized.
The study’s strengths include the use of the NSQIP database’s prospectively collected data to construct the cohort study; the data base included “important patient-level factors such as uterine size, obesity, and comorbidities not previously available in other secondary data set studies,” noted Dr. Alexander and her colleagues. But the possibility of unmeasured bias persists, they said, and such variables as regional practice patterns and surgeon experience and procedure volume could not be detected from the NSQIP data on hand.
“This study suggests that an important step to reduce the disparity in route of surgery and postoperative complications is to increase access to and use of minimally invasive surgery,” wrote Dr. Alexander and her coauthors.
The study was funded by the National Institutes of Health. Dr. Alexander and her colleagues reported no conflicts of interest.
koakes@mdedge.com
SOURCE: Alexander AL et al. Obstet Gynecol. 2018 Dec 4. doi: 10.1097/AOG.0000000000002990
FROM OBSTETRICS & GYNECOLOGY
Key clinical point: Black women were more likely than white women were to have open hysterectomies.
Major finding:
Study details: Analysis of prospectively collected hysterectomy data of 15,136 women in the NSQIP database.
Disclosures: The study was funded by the National Institutes of Health. Dr. Alexander and her coauthors reported no conflicts of interest.
Source: Alexander AL et al. Obstet Gynecol. 2018 Dec 4. doi: 10.1097/AOG0000000000002990.
Uterine tissue extraction: An update, with a look at tools and techniques
At the 2018 Pelvic Anatomy and Gynecologic Surgery Symposium meeting in Las Vegas, Nevada, Tommaso Falcone, MD, Chief of Staff, Chief Academic Officer, and Medical Director at Cleveland Clinic London, England, addressed the status of tissue morcellation in hysterectomy and myomectomy after several years’ controversy—noting that the specialty’s professional societies all support use of the technique, with precautions and in selected patients.
Morcellation history
Should electromechanical (‘power’) morcellation of tissue be a tool for performing minimally invasive hysterectomy and myomectomy? If so, what are the risks and benefits of using this tool, first approved by the US Food and Drug Administration (FDA) in 1995?
The matter came under intense scrutiny and debate in 2014 as concerns rose about the potential of power morcellation to disseminate intraperitoneal malignancy in women with occult cancer (an estimated 1 in 370 women who undergo power morcellation during a minimally invasive hysterectomy have uterine cancer1). Early that year, the FDA moved to strongly discourage use of power morcellators for removing uterine fibroids.2
The aftermath, however, was that there were problems with the FDA’s [2014] statement, Dr. Falcone pointed out. In a study by Siedhoff and colleagues of a hypothetical cohort of 100,000 women with fibroids, for example, an abdominal approach resulted in more hysterectomy-related deaths and surgery-related complications than did a laparoscopic procedure with morcellation.3
Balancing risks and benefits of MIS
After continuing study of the risks presented by morcellation, the question today is: How do we balance preventing dissemination of cancer against diminishing the significant benefits of minimally invasive surgery, as surgical technique has been modified to avoid morcellation—including, Dr. Falcone said, by increased use of mini lap (i.e., extending the laparoscopy incision) tissue extraction, decreased use of supracervical hysterectomy, and a move to open approaches.
In fact, Dr. Falcone noted, power morcellation is banned in many institutions, having been replaced by scalpel, extraperitoneal, or in-bag morcellation. Last year, after further analysis, the FDA reiterated its recommendation against use of power morcellators to remove fibroids in most women.4
Continue to: Morcellation decisions
Morcellation decisions
Dr. Falcone pointed out that, at the Cleveland Clinic, morcellation is not performed in postmenopausal women, and for several other contraindications, including a history of >2 years of tamoxifen therapy; history of pelvic radiation; history of childhood retinoblastoma; personal history of hereditary leiomyomatosis or renal cell carcinoma; and the presence of a cancer-positive tissue specimen. Morcellation is not performed unless endometrial adenocarcinoma has been ruled out. The decision-making process when electing to use tissue extraction includes whether to use contained or noncontained morcellation; whether to favor knife excision over power morcellation; and, when using a mini lap approach, whether to proceed via the umbilicus or suprapubically.
Complications of morcellation include direct injury by the morcellator; dissemination, as noted, of tissue; ‘upstaging’ of uterine sarcoma, with a worsening prognosis; seeding of parasitic fibroids; and reoperation with laparotomy and extensive multi-organ resection to clear disease (3 patients in a published report).5
An important advancement in the use of morcellation in minimally invasive hysterectomy or myomectomy has been the development of contained systems for morcellating—generally a plastic specimen bag, sometimes pulled through the port and insufflated. Dr. Falcone’s presentation included video presentations of this important, and still evolving, technology. Whether these contained systems improve survival, and whether using them in a vaginal approach makes any difference, remain uncertain, however. Furthermore, some spillage from bags is inevitable—although how much spillage is clinically significant is open to question.
Takeaways
Dr. Falcone concluded with key points to guide the surgeon’s decision on whether to proceed with morcellation:
- There are no comparative data on which technique [of tissue removal] is best.
- Tissue spill will occur in uncontained morcellation—this is intrinsic to the device.
- Even with the current generation of tissue bags, leakage is common and puncture is possible.
If you choose to continue to use power morcellation, your decision is supported by the fact that all the professional societies still support it, Dr. Falcone noted. Furthermore, he pointed out that it is important to look to the standard of care in your community regarding risks and benefits before proceeding.
Last, the advantages and risks of morcellation in hysterectomy and myomectomy should be part of an in-depth discussion between patient and surgeon prior to the procedure. And you must, Dr. Falcone emphasized, obtain specific informed consent.
- Wright JD, Tergas AI, Burke WM, et al. Uterine pathology in women undergoing minimally invasive hysterectomy using morcellation. JAMA. Published online July 22, 2014. Accessed December 10, 2018.
- US Food and Drug Administration. Laparoscopic uterine power morcellation in hysterectomy and myomectomy: FDA safety communication. November 24, 2014. http://wayback.archive-it.org/7993/20170722215727/https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm. Updated June 6, 2017. Accessed December 10, 2018.
- Siedhoff MT, Wheeler SB, Rutstein SE, et al. Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroid tumors in premenopausal women: a decision analysis. Am J Obstet Gynecol. 2015;212:591.e1–e8.
- FDA In Brief: FDA releases new findings on the risks of spreading hidden uterine cancer through the use of laparoscopic power morcellators. https://www.fda.gov/newsevents/newsroom/fdainbrief/ucm589137.htm. Updated December 14, 2017. Accessed December 10, 2018.
- Ramos A, Fader AN, Roche KL. Surgical cytoreduction for disseminated benign disease after open power uterine morcellation. Obstet Gynecol. 2015;125:99-102.
At the 2018 Pelvic Anatomy and Gynecologic Surgery Symposium meeting in Las Vegas, Nevada, Tommaso Falcone, MD, Chief of Staff, Chief Academic Officer, and Medical Director at Cleveland Clinic London, England, addressed the status of tissue morcellation in hysterectomy and myomectomy after several years’ controversy—noting that the specialty’s professional societies all support use of the technique, with precautions and in selected patients.
Morcellation history
Should electromechanical (‘power’) morcellation of tissue be a tool for performing minimally invasive hysterectomy and myomectomy? If so, what are the risks and benefits of using this tool, first approved by the US Food and Drug Administration (FDA) in 1995?
The matter came under intense scrutiny and debate in 2014 as concerns rose about the potential of power morcellation to disseminate intraperitoneal malignancy in women with occult cancer (an estimated 1 in 370 women who undergo power morcellation during a minimally invasive hysterectomy have uterine cancer1). Early that year, the FDA moved to strongly discourage use of power morcellators for removing uterine fibroids.2
The aftermath, however, was that there were problems with the FDA’s [2014] statement, Dr. Falcone pointed out. In a study by Siedhoff and colleagues of a hypothetical cohort of 100,000 women with fibroids, for example, an abdominal approach resulted in more hysterectomy-related deaths and surgery-related complications than did a laparoscopic procedure with morcellation.3
Balancing risks and benefits of MIS
After continuing study of the risks presented by morcellation, the question today is: How do we balance preventing dissemination of cancer against diminishing the significant benefits of minimally invasive surgery, as surgical technique has been modified to avoid morcellation—including, Dr. Falcone said, by increased use of mini lap (i.e., extending the laparoscopy incision) tissue extraction, decreased use of supracervical hysterectomy, and a move to open approaches.
In fact, Dr. Falcone noted, power morcellation is banned in many institutions, having been replaced by scalpel, extraperitoneal, or in-bag morcellation. Last year, after further analysis, the FDA reiterated its recommendation against use of power morcellators to remove fibroids in most women.4
Continue to: Morcellation decisions
Morcellation decisions
Dr. Falcone pointed out that, at the Cleveland Clinic, morcellation is not performed in postmenopausal women, and for several other contraindications, including a history of >2 years of tamoxifen therapy; history of pelvic radiation; history of childhood retinoblastoma; personal history of hereditary leiomyomatosis or renal cell carcinoma; and the presence of a cancer-positive tissue specimen. Morcellation is not performed unless endometrial adenocarcinoma has been ruled out. The decision-making process when electing to use tissue extraction includes whether to use contained or noncontained morcellation; whether to favor knife excision over power morcellation; and, when using a mini lap approach, whether to proceed via the umbilicus or suprapubically.
Complications of morcellation include direct injury by the morcellator; dissemination, as noted, of tissue; ‘upstaging’ of uterine sarcoma, with a worsening prognosis; seeding of parasitic fibroids; and reoperation with laparotomy and extensive multi-organ resection to clear disease (3 patients in a published report).5
An important advancement in the use of morcellation in minimally invasive hysterectomy or myomectomy has been the development of contained systems for morcellating—generally a plastic specimen bag, sometimes pulled through the port and insufflated. Dr. Falcone’s presentation included video presentations of this important, and still evolving, technology. Whether these contained systems improve survival, and whether using them in a vaginal approach makes any difference, remain uncertain, however. Furthermore, some spillage from bags is inevitable—although how much spillage is clinically significant is open to question.
Takeaways
Dr. Falcone concluded with key points to guide the surgeon’s decision on whether to proceed with morcellation:
- There are no comparative data on which technique [of tissue removal] is best.
- Tissue spill will occur in uncontained morcellation—this is intrinsic to the device.
- Even with the current generation of tissue bags, leakage is common and puncture is possible.
If you choose to continue to use power morcellation, your decision is supported by the fact that all the professional societies still support it, Dr. Falcone noted. Furthermore, he pointed out that it is important to look to the standard of care in your community regarding risks and benefits before proceeding.
Last, the advantages and risks of morcellation in hysterectomy and myomectomy should be part of an in-depth discussion between patient and surgeon prior to the procedure. And you must, Dr. Falcone emphasized, obtain specific informed consent.
At the 2018 Pelvic Anatomy and Gynecologic Surgery Symposium meeting in Las Vegas, Nevada, Tommaso Falcone, MD, Chief of Staff, Chief Academic Officer, and Medical Director at Cleveland Clinic London, England, addressed the status of tissue morcellation in hysterectomy and myomectomy after several years’ controversy—noting that the specialty’s professional societies all support use of the technique, with precautions and in selected patients.
Morcellation history
Should electromechanical (‘power’) morcellation of tissue be a tool for performing minimally invasive hysterectomy and myomectomy? If so, what are the risks and benefits of using this tool, first approved by the US Food and Drug Administration (FDA) in 1995?
The matter came under intense scrutiny and debate in 2014 as concerns rose about the potential of power morcellation to disseminate intraperitoneal malignancy in women with occult cancer (an estimated 1 in 370 women who undergo power morcellation during a minimally invasive hysterectomy have uterine cancer1). Early that year, the FDA moved to strongly discourage use of power morcellators for removing uterine fibroids.2
The aftermath, however, was that there were problems with the FDA’s [2014] statement, Dr. Falcone pointed out. In a study by Siedhoff and colleagues of a hypothetical cohort of 100,000 women with fibroids, for example, an abdominal approach resulted in more hysterectomy-related deaths and surgery-related complications than did a laparoscopic procedure with morcellation.3
Balancing risks and benefits of MIS
After continuing study of the risks presented by morcellation, the question today is: How do we balance preventing dissemination of cancer against diminishing the significant benefits of minimally invasive surgery, as surgical technique has been modified to avoid morcellation—including, Dr. Falcone said, by increased use of mini lap (i.e., extending the laparoscopy incision) tissue extraction, decreased use of supracervical hysterectomy, and a move to open approaches.
In fact, Dr. Falcone noted, power morcellation is banned in many institutions, having been replaced by scalpel, extraperitoneal, or in-bag morcellation. Last year, after further analysis, the FDA reiterated its recommendation against use of power morcellators to remove fibroids in most women.4
Continue to: Morcellation decisions
Morcellation decisions
Dr. Falcone pointed out that, at the Cleveland Clinic, morcellation is not performed in postmenopausal women, and for several other contraindications, including a history of >2 years of tamoxifen therapy; history of pelvic radiation; history of childhood retinoblastoma; personal history of hereditary leiomyomatosis or renal cell carcinoma; and the presence of a cancer-positive tissue specimen. Morcellation is not performed unless endometrial adenocarcinoma has been ruled out. The decision-making process when electing to use tissue extraction includes whether to use contained or noncontained morcellation; whether to favor knife excision over power morcellation; and, when using a mini lap approach, whether to proceed via the umbilicus or suprapubically.
Complications of morcellation include direct injury by the morcellator; dissemination, as noted, of tissue; ‘upstaging’ of uterine sarcoma, with a worsening prognosis; seeding of parasitic fibroids; and reoperation with laparotomy and extensive multi-organ resection to clear disease (3 patients in a published report).5
An important advancement in the use of morcellation in minimally invasive hysterectomy or myomectomy has been the development of contained systems for morcellating—generally a plastic specimen bag, sometimes pulled through the port and insufflated. Dr. Falcone’s presentation included video presentations of this important, and still evolving, technology. Whether these contained systems improve survival, and whether using them in a vaginal approach makes any difference, remain uncertain, however. Furthermore, some spillage from bags is inevitable—although how much spillage is clinically significant is open to question.
Takeaways
Dr. Falcone concluded with key points to guide the surgeon’s decision on whether to proceed with morcellation:
- There are no comparative data on which technique [of tissue removal] is best.
- Tissue spill will occur in uncontained morcellation—this is intrinsic to the device.
- Even with the current generation of tissue bags, leakage is common and puncture is possible.
If you choose to continue to use power morcellation, your decision is supported by the fact that all the professional societies still support it, Dr. Falcone noted. Furthermore, he pointed out that it is important to look to the standard of care in your community regarding risks and benefits before proceeding.
Last, the advantages and risks of morcellation in hysterectomy and myomectomy should be part of an in-depth discussion between patient and surgeon prior to the procedure. And you must, Dr. Falcone emphasized, obtain specific informed consent.
- Wright JD, Tergas AI, Burke WM, et al. Uterine pathology in women undergoing minimally invasive hysterectomy using morcellation. JAMA. Published online July 22, 2014. Accessed December 10, 2018.
- US Food and Drug Administration. Laparoscopic uterine power morcellation in hysterectomy and myomectomy: FDA safety communication. November 24, 2014. http://wayback.archive-it.org/7993/20170722215727/https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm. Updated June 6, 2017. Accessed December 10, 2018.
- Siedhoff MT, Wheeler SB, Rutstein SE, et al. Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroid tumors in premenopausal women: a decision analysis. Am J Obstet Gynecol. 2015;212:591.e1–e8.
- FDA In Brief: FDA releases new findings on the risks of spreading hidden uterine cancer through the use of laparoscopic power morcellators. https://www.fda.gov/newsevents/newsroom/fdainbrief/ucm589137.htm. Updated December 14, 2017. Accessed December 10, 2018.
- Ramos A, Fader AN, Roche KL. Surgical cytoreduction for disseminated benign disease after open power uterine morcellation. Obstet Gynecol. 2015;125:99-102.
- Wright JD, Tergas AI, Burke WM, et al. Uterine pathology in women undergoing minimally invasive hysterectomy using morcellation. JAMA. Published online July 22, 2014. Accessed December 10, 2018.
- US Food and Drug Administration. Laparoscopic uterine power morcellation in hysterectomy and myomectomy: FDA safety communication. November 24, 2014. http://wayback.archive-it.org/7993/20170722215727/https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm. Updated June 6, 2017. Accessed December 10, 2018.
- Siedhoff MT, Wheeler SB, Rutstein SE, et al. Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroid tumors in premenopausal women: a decision analysis. Am J Obstet Gynecol. 2015;212:591.e1–e8.
- FDA In Brief: FDA releases new findings on the risks of spreading hidden uterine cancer through the use of laparoscopic power morcellators. https://www.fda.gov/newsevents/newsroom/fdainbrief/ucm589137.htm. Updated December 14, 2017. Accessed December 10, 2018.
- Ramos A, Fader AN, Roche KL. Surgical cytoreduction for disseminated benign disease after open power uterine morcellation. Obstet Gynecol. 2015;125:99-102.
NSAIDs can play major role in pre- and postoperative hysterectomy pain
LAS VEGAS – An ob.gyn. has some handy hysterectomy-related pain management tips for her colleagues: Don’t assume patients know how to titrate between NSAIDs and opioids after surgery. Consider neuropathic medications alone in patients undergoing minimally invasive hysterectomies. And
Sawsan As-Sanie, MD, MPH, director of the University of Michigan Endometriosis Center, Ann Arbor, offered these and other recommendations about hysterectomy-related pain at the Pelvic Anatomy and Gynecologic Surgery Symposium.
Try acetaminophen and an NSAID
In the preoperative period, a combination of acetaminophen (Tylenol) and an NSAID can provide significant postop relief, Dr. As-Sanie said.
She highlighted a 2010 systematic review of 21 studies that included 1,909 patients and found acetaminophen/NSAID combinations improved pain intensity by about 35% in positive studies when compared with either acetaminophen or NSAID alone. The painkiller combination was positive – more effective than a solo agent – in 85% of studies of combo versus acetaminophen alone and 64% of studies of combo versus NSAID alone (Anesth Analg. 2010 Apr 1;110[4]:1170-9).
Another study, she said, found that there’s no clear advantage to IV administration for acetaminophen if patients can take the drug orally (Can J Hosp Pharm. 2015 May-Jun;68[3]:238-47).
Consider gabapentin, but not postoperatively
Dr. As-Sanie pointed to a 2014 systematic review and meta-analysis that suggested the use of preoperative gabapentin in abdominal hysterectomy reduces pain and opioid use. However, adding postoperative doses of gabapentin, she said, don’t appear to produce a greater effect (Obstet Gynecol. 2014 Jun;123[6]:1221-9).
Consider neuropathics for minimally invasive hysterectomy
Two studies, one in 2004 and the other in 2008, suggest that gabapentin (on a postop basis) and pregabalin (perioperatively) can reduce postop opioid use. (Pregabalin also was linked to more adverse effects.) “Even if they’re having a little bit of pain, they’re using fewer opioids,” she said (Pain. 2004 Jul;110[1-2]:175-81; Pain. 2008 Jan;134[1-2]:106-12).
Educate patients about postop painkiller use
Don’t assume that patients know how to adjust their over-the-counter painkiller use after surgery, Dr. As-Sanie said at the meeting jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company. “While we as physicians think that knowledge about the use of ibuprofen and Tylenol is something everyone should be born with, it’s not obvious to most patients and families.”
It’s important to teach patients to start with NSAIDs or Tylenol postoperatively, and if that doesn’t control pain, “you add opioids and use medications to control constipation as needed. As you recover, you reduce the amount of opioids first and then reduce the NSAIDs or Tylenol,” she said. “That education can be very helpful for the vast majority of patients, and it’s one of the most important things we can provide.”
Don’t over-prescribe opioids
For a 2017 study, Dr. As-Sanie and colleagues tracked hysterectomy patients and surveyed them about their postop opioid use. “When asked 2 weeks after surgery, most used far less than half of what they prescribed,” Dr. As-Sanie said. “If we gave them about 40 pills, they had between 13-15 pills left after the surgery on average. Nearly 50% didn’t use any of their medication” (Obstet Gynecol. 2017 Dec;130[6]:1261-8).
Dr. As-Sanie urged colleagues to remember the lesson of the rise of super-sized portions at fast-food restaurants: Give people more of something and they’ll eat (or use) more of it. And the reverse is true: “If you give people fewer pills, they will use fewer pills.”
Dr. As-Sanie highlighted the recommendations about opioid prescription levels for various surgical procedures, including different types of hysterectomies, at www.opioidprescribing.info. The recommendations are provided by the Michigan Opioid Prescribing Engagement Network. They’re designed for opioid-naive patients and suggest the lowest doses for vaginal hysterectomy and the highest for abdominal hysterectomy, with recommended doses for laparoscopic and robotic hysterectomy in between.
Dr. As-Sanie disclosed she is a consultant for AbbVie and Myovant.
LAS VEGAS – An ob.gyn. has some handy hysterectomy-related pain management tips for her colleagues: Don’t assume patients know how to titrate between NSAIDs and opioids after surgery. Consider neuropathic medications alone in patients undergoing minimally invasive hysterectomies. And
Sawsan As-Sanie, MD, MPH, director of the University of Michigan Endometriosis Center, Ann Arbor, offered these and other recommendations about hysterectomy-related pain at the Pelvic Anatomy and Gynecologic Surgery Symposium.
Try acetaminophen and an NSAID
In the preoperative period, a combination of acetaminophen (Tylenol) and an NSAID can provide significant postop relief, Dr. As-Sanie said.
She highlighted a 2010 systematic review of 21 studies that included 1,909 patients and found acetaminophen/NSAID combinations improved pain intensity by about 35% in positive studies when compared with either acetaminophen or NSAID alone. The painkiller combination was positive – more effective than a solo agent – in 85% of studies of combo versus acetaminophen alone and 64% of studies of combo versus NSAID alone (Anesth Analg. 2010 Apr 1;110[4]:1170-9).
Another study, she said, found that there’s no clear advantage to IV administration for acetaminophen if patients can take the drug orally (Can J Hosp Pharm. 2015 May-Jun;68[3]:238-47).
Consider gabapentin, but not postoperatively
Dr. As-Sanie pointed to a 2014 systematic review and meta-analysis that suggested the use of preoperative gabapentin in abdominal hysterectomy reduces pain and opioid use. However, adding postoperative doses of gabapentin, she said, don’t appear to produce a greater effect (Obstet Gynecol. 2014 Jun;123[6]:1221-9).
Consider neuropathics for minimally invasive hysterectomy
Two studies, one in 2004 and the other in 2008, suggest that gabapentin (on a postop basis) and pregabalin (perioperatively) can reduce postop opioid use. (Pregabalin also was linked to more adverse effects.) “Even if they’re having a little bit of pain, they’re using fewer opioids,” she said (Pain. 2004 Jul;110[1-2]:175-81; Pain. 2008 Jan;134[1-2]:106-12).
Educate patients about postop painkiller use
Don’t assume that patients know how to adjust their over-the-counter painkiller use after surgery, Dr. As-Sanie said at the meeting jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company. “While we as physicians think that knowledge about the use of ibuprofen and Tylenol is something everyone should be born with, it’s not obvious to most patients and families.”
It’s important to teach patients to start with NSAIDs or Tylenol postoperatively, and if that doesn’t control pain, “you add opioids and use medications to control constipation as needed. As you recover, you reduce the amount of opioids first and then reduce the NSAIDs or Tylenol,” she said. “That education can be very helpful for the vast majority of patients, and it’s one of the most important things we can provide.”
Don’t over-prescribe opioids
For a 2017 study, Dr. As-Sanie and colleagues tracked hysterectomy patients and surveyed them about their postop opioid use. “When asked 2 weeks after surgery, most used far less than half of what they prescribed,” Dr. As-Sanie said. “If we gave them about 40 pills, they had between 13-15 pills left after the surgery on average. Nearly 50% didn’t use any of their medication” (Obstet Gynecol. 2017 Dec;130[6]:1261-8).
Dr. As-Sanie urged colleagues to remember the lesson of the rise of super-sized portions at fast-food restaurants: Give people more of something and they’ll eat (or use) more of it. And the reverse is true: “If you give people fewer pills, they will use fewer pills.”
Dr. As-Sanie highlighted the recommendations about opioid prescription levels for various surgical procedures, including different types of hysterectomies, at www.opioidprescribing.info. The recommendations are provided by the Michigan Opioid Prescribing Engagement Network. They’re designed for opioid-naive patients and suggest the lowest doses for vaginal hysterectomy and the highest for abdominal hysterectomy, with recommended doses for laparoscopic and robotic hysterectomy in between.
Dr. As-Sanie disclosed she is a consultant for AbbVie and Myovant.
LAS VEGAS – An ob.gyn. has some handy hysterectomy-related pain management tips for her colleagues: Don’t assume patients know how to titrate between NSAIDs and opioids after surgery. Consider neuropathic medications alone in patients undergoing minimally invasive hysterectomies. And
Sawsan As-Sanie, MD, MPH, director of the University of Michigan Endometriosis Center, Ann Arbor, offered these and other recommendations about hysterectomy-related pain at the Pelvic Anatomy and Gynecologic Surgery Symposium.
Try acetaminophen and an NSAID
In the preoperative period, a combination of acetaminophen (Tylenol) and an NSAID can provide significant postop relief, Dr. As-Sanie said.
She highlighted a 2010 systematic review of 21 studies that included 1,909 patients and found acetaminophen/NSAID combinations improved pain intensity by about 35% in positive studies when compared with either acetaminophen or NSAID alone. The painkiller combination was positive – more effective than a solo agent – in 85% of studies of combo versus acetaminophen alone and 64% of studies of combo versus NSAID alone (Anesth Analg. 2010 Apr 1;110[4]:1170-9).
Another study, she said, found that there’s no clear advantage to IV administration for acetaminophen if patients can take the drug orally (Can J Hosp Pharm. 2015 May-Jun;68[3]:238-47).
Consider gabapentin, but not postoperatively
Dr. As-Sanie pointed to a 2014 systematic review and meta-analysis that suggested the use of preoperative gabapentin in abdominal hysterectomy reduces pain and opioid use. However, adding postoperative doses of gabapentin, she said, don’t appear to produce a greater effect (Obstet Gynecol. 2014 Jun;123[6]:1221-9).
Consider neuropathics for minimally invasive hysterectomy
Two studies, one in 2004 and the other in 2008, suggest that gabapentin (on a postop basis) and pregabalin (perioperatively) can reduce postop opioid use. (Pregabalin also was linked to more adverse effects.) “Even if they’re having a little bit of pain, they’re using fewer opioids,” she said (Pain. 2004 Jul;110[1-2]:175-81; Pain. 2008 Jan;134[1-2]:106-12).
Educate patients about postop painkiller use
Don’t assume that patients know how to adjust their over-the-counter painkiller use after surgery, Dr. As-Sanie said at the meeting jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company. “While we as physicians think that knowledge about the use of ibuprofen and Tylenol is something everyone should be born with, it’s not obvious to most patients and families.”
It’s important to teach patients to start with NSAIDs or Tylenol postoperatively, and if that doesn’t control pain, “you add opioids and use medications to control constipation as needed. As you recover, you reduce the amount of opioids first and then reduce the NSAIDs or Tylenol,” she said. “That education can be very helpful for the vast majority of patients, and it’s one of the most important things we can provide.”
Don’t over-prescribe opioids
For a 2017 study, Dr. As-Sanie and colleagues tracked hysterectomy patients and surveyed them about their postop opioid use. “When asked 2 weeks after surgery, most used far less than half of what they prescribed,” Dr. As-Sanie said. “If we gave them about 40 pills, they had between 13-15 pills left after the surgery on average. Nearly 50% didn’t use any of their medication” (Obstet Gynecol. 2017 Dec;130[6]:1261-8).
Dr. As-Sanie urged colleagues to remember the lesson of the rise of super-sized portions at fast-food restaurants: Give people more of something and they’ll eat (or use) more of it. And the reverse is true: “If you give people fewer pills, they will use fewer pills.”
Dr. As-Sanie highlighted the recommendations about opioid prescription levels for various surgical procedures, including different types of hysterectomies, at www.opioidprescribing.info. The recommendations are provided by the Michigan Opioid Prescribing Engagement Network. They’re designed for opioid-naive patients and suggest the lowest doses for vaginal hysterectomy and the highest for abdominal hysterectomy, with recommended doses for laparoscopic and robotic hysterectomy in between.
Dr. As-Sanie disclosed she is a consultant for AbbVie and Myovant.
EXPERT ANALYSIS FROM PAGS
When is it appropriate to remove ovaries in hysterectomy?
LAS VEGAS – The removal of both ovaries during hysterectomy – bilateral salpingo-oophorectomy (BSO) – has declined sharply in popularity as physicians have become more aware of its risks.
Still, “we’re still seeing a relatively high rate of inappropriate BSO,” Amanda Nickles Fader, MD, said, despite “the many benefits of ovarian conservation. Strong consideration should be made for maintaining normal ovaries in premenopausal women who are not at higher genetic risk of ovarian cancer.”
Dr. Nickles Fader, director of the Kelly gynecologic oncology service and the director of the center for rare gynecologic cancers at Johns Hopkins Hospital, Baltimore, who spoke at the Pelvic Anatomy and Gynecologic Surgery Symposium, urged gynecologists to understand the data about ovarian conservation in hysterectomy and carefully counsel patients.
“We can counsel patients with 100% certainty that BSO absolutely reduces ovarian and fallopian tube cancer rates. That’s a given,” she said. “Women get very excited about that, but you’ve got to be careful to counsel them about the flip side: The overall benefit may not be there when you consider the other morbidity and mortality that may occur because of this removal.”
As she noted, multiple retrospective, prospective, and observational studies have linked ovary removal to a variety of heightened risks, especially on the cardiac front. She highlighted a 2009 study of nearly 30,000 nurses who’d undergone hysterectomy for benign disease, about which the authors wrote that, “compared with ovarian conservation, bilateral oophorectomy at the time of hysterectomy for benign disease is associated with a decreased risk of breast and ovarian cancer but an increased risk of all-cause mortality, fatal and nonfatal coronary heart disease, and lung cancer.” No age group gained a survival benefit from oophorectomy (Obstet Gynecol. 2009 May;113[5]:1027-37 ).
Meanwhile, over the past decade, the “pendulum has swung” toward ovary conservation, at least in premenopausal women, Dr. Nickles Fader said at the meeting jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.
A 2016 analysis of health statistics in five U.S. Eastern and Midwestern states found that, rates of hospital-based, hysterectomy-alone procedures grew by 15% from 2005 to 2013, while rates of oophorectomy alone and hysterectomy/oophorectomy combination procedures declined by 12% and 29%, respectively.
Still, Dr. Nickles Fader said, as many as 60% of hysterectomies are still performed in conjunction with oophorectomy.
Ovary removal, of course, can be appropriate when patients are at risk of ovarian cancer. Hereditary ovarian cancer accounts for up to 25% of epithelial ovarian cancer, she said, and research suggests that risk-reducing surgery is an effective preventative approach when high-penetrance genes are present. However, the value of the surgery is less clear in regard to moderate-penetrance genes.
Dr. Nickles Fader pointed to guidelines from the National Comprehensive Cancer Network that specify genes and syndromes that should trigger risk-reducing salpingo-oophorectomy, hysterectomy, or hysterectomy and risk-reducing salpingo-oophorectomy after childbirth.
Researchers are exploring salpingectomy – fallopian tube removal – as a possible replacement for oophorectomy. Dr. Nickles Fader highlighted a small pilot study published in 2018 that reported “BRCA mutation carriers who underwent bilateral salpingectomy had no intraoperative complications, were satisfied with their procedure choice, and had decreased cancer worry and anxiety after the procedure.”
Moving forward, she said, research will provide more insight into preventative options such as removing fallopian tubes alone instead of ovaries. “We’re starting to learn, and will probably know in the next 10-15 years, whether oophorectomy is necessary for all high-risk and moderate-risk women or if we can get away with removing their tubes and giving them the maximal health benefits of ovarian conservation.”
Dr. Nickles Fader reported consulting for Ethicon Endosurgery.
LAS VEGAS – The removal of both ovaries during hysterectomy – bilateral salpingo-oophorectomy (BSO) – has declined sharply in popularity as physicians have become more aware of its risks.
Still, “we’re still seeing a relatively high rate of inappropriate BSO,” Amanda Nickles Fader, MD, said, despite “the many benefits of ovarian conservation. Strong consideration should be made for maintaining normal ovaries in premenopausal women who are not at higher genetic risk of ovarian cancer.”
Dr. Nickles Fader, director of the Kelly gynecologic oncology service and the director of the center for rare gynecologic cancers at Johns Hopkins Hospital, Baltimore, who spoke at the Pelvic Anatomy and Gynecologic Surgery Symposium, urged gynecologists to understand the data about ovarian conservation in hysterectomy and carefully counsel patients.
“We can counsel patients with 100% certainty that BSO absolutely reduces ovarian and fallopian tube cancer rates. That’s a given,” she said. “Women get very excited about that, but you’ve got to be careful to counsel them about the flip side: The overall benefit may not be there when you consider the other morbidity and mortality that may occur because of this removal.”
As she noted, multiple retrospective, prospective, and observational studies have linked ovary removal to a variety of heightened risks, especially on the cardiac front. She highlighted a 2009 study of nearly 30,000 nurses who’d undergone hysterectomy for benign disease, about which the authors wrote that, “compared with ovarian conservation, bilateral oophorectomy at the time of hysterectomy for benign disease is associated with a decreased risk of breast and ovarian cancer but an increased risk of all-cause mortality, fatal and nonfatal coronary heart disease, and lung cancer.” No age group gained a survival benefit from oophorectomy (Obstet Gynecol. 2009 May;113[5]:1027-37 ).
Meanwhile, over the past decade, the “pendulum has swung” toward ovary conservation, at least in premenopausal women, Dr. Nickles Fader said at the meeting jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.
A 2016 analysis of health statistics in five U.S. Eastern and Midwestern states found that, rates of hospital-based, hysterectomy-alone procedures grew by 15% from 2005 to 2013, while rates of oophorectomy alone and hysterectomy/oophorectomy combination procedures declined by 12% and 29%, respectively.
Still, Dr. Nickles Fader said, as many as 60% of hysterectomies are still performed in conjunction with oophorectomy.
Ovary removal, of course, can be appropriate when patients are at risk of ovarian cancer. Hereditary ovarian cancer accounts for up to 25% of epithelial ovarian cancer, she said, and research suggests that risk-reducing surgery is an effective preventative approach when high-penetrance genes are present. However, the value of the surgery is less clear in regard to moderate-penetrance genes.
Dr. Nickles Fader pointed to guidelines from the National Comprehensive Cancer Network that specify genes and syndromes that should trigger risk-reducing salpingo-oophorectomy, hysterectomy, or hysterectomy and risk-reducing salpingo-oophorectomy after childbirth.
Researchers are exploring salpingectomy – fallopian tube removal – as a possible replacement for oophorectomy. Dr. Nickles Fader highlighted a small pilot study published in 2018 that reported “BRCA mutation carriers who underwent bilateral salpingectomy had no intraoperative complications, were satisfied with their procedure choice, and had decreased cancer worry and anxiety after the procedure.”
Moving forward, she said, research will provide more insight into preventative options such as removing fallopian tubes alone instead of ovaries. “We’re starting to learn, and will probably know in the next 10-15 years, whether oophorectomy is necessary for all high-risk and moderate-risk women or if we can get away with removing their tubes and giving them the maximal health benefits of ovarian conservation.”
Dr. Nickles Fader reported consulting for Ethicon Endosurgery.
LAS VEGAS – The removal of both ovaries during hysterectomy – bilateral salpingo-oophorectomy (BSO) – has declined sharply in popularity as physicians have become more aware of its risks.
Still, “we’re still seeing a relatively high rate of inappropriate BSO,” Amanda Nickles Fader, MD, said, despite “the many benefits of ovarian conservation. Strong consideration should be made for maintaining normal ovaries in premenopausal women who are not at higher genetic risk of ovarian cancer.”
Dr. Nickles Fader, director of the Kelly gynecologic oncology service and the director of the center for rare gynecologic cancers at Johns Hopkins Hospital, Baltimore, who spoke at the Pelvic Anatomy and Gynecologic Surgery Symposium, urged gynecologists to understand the data about ovarian conservation in hysterectomy and carefully counsel patients.
“We can counsel patients with 100% certainty that BSO absolutely reduces ovarian and fallopian tube cancer rates. That’s a given,” she said. “Women get very excited about that, but you’ve got to be careful to counsel them about the flip side: The overall benefit may not be there when you consider the other morbidity and mortality that may occur because of this removal.”
As she noted, multiple retrospective, prospective, and observational studies have linked ovary removal to a variety of heightened risks, especially on the cardiac front. She highlighted a 2009 study of nearly 30,000 nurses who’d undergone hysterectomy for benign disease, about which the authors wrote that, “compared with ovarian conservation, bilateral oophorectomy at the time of hysterectomy for benign disease is associated with a decreased risk of breast and ovarian cancer but an increased risk of all-cause mortality, fatal and nonfatal coronary heart disease, and lung cancer.” No age group gained a survival benefit from oophorectomy (Obstet Gynecol. 2009 May;113[5]:1027-37 ).
Meanwhile, over the past decade, the “pendulum has swung” toward ovary conservation, at least in premenopausal women, Dr. Nickles Fader said at the meeting jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.
A 2016 analysis of health statistics in five U.S. Eastern and Midwestern states found that, rates of hospital-based, hysterectomy-alone procedures grew by 15% from 2005 to 2013, while rates of oophorectomy alone and hysterectomy/oophorectomy combination procedures declined by 12% and 29%, respectively.
Still, Dr. Nickles Fader said, as many as 60% of hysterectomies are still performed in conjunction with oophorectomy.
Ovary removal, of course, can be appropriate when patients are at risk of ovarian cancer. Hereditary ovarian cancer accounts for up to 25% of epithelial ovarian cancer, she said, and research suggests that risk-reducing surgery is an effective preventative approach when high-penetrance genes are present. However, the value of the surgery is less clear in regard to moderate-penetrance genes.
Dr. Nickles Fader pointed to guidelines from the National Comprehensive Cancer Network that specify genes and syndromes that should trigger risk-reducing salpingo-oophorectomy, hysterectomy, or hysterectomy and risk-reducing salpingo-oophorectomy after childbirth.
Researchers are exploring salpingectomy – fallopian tube removal – as a possible replacement for oophorectomy. Dr. Nickles Fader highlighted a small pilot study published in 2018 that reported “BRCA mutation carriers who underwent bilateral salpingectomy had no intraoperative complications, were satisfied with their procedure choice, and had decreased cancer worry and anxiety after the procedure.”
Moving forward, she said, research will provide more insight into preventative options such as removing fallopian tubes alone instead of ovaries. “We’re starting to learn, and will probably know in the next 10-15 years, whether oophorectomy is necessary for all high-risk and moderate-risk women or if we can get away with removing their tubes and giving them the maximal health benefits of ovarian conservation.”
Dr. Nickles Fader reported consulting for Ethicon Endosurgery.
EXPERT ANALYSIS FROM PAGS
Cervical bupivacaine blocks pain after laparoscopic hysterectomy
LAS VEGAS – according to a small trial at the University of Tennessee, Chattanooga.
Twenty-one women were randomized to 0.5% bupivacaine, 5 mL injected into the cervix at the 3 o’clock position, and 5 mL injected into at the 9 o’clock position to a depth of 3 cm, after anesthesia induction but before insertion of the uterine manipulator. A control group of 20 women received 5 mL of 0.9% saline injected into the same positions. Surgeons were blinded to the randomization.
A stopwatch was started at extubation, and the women were asked to rate their pain on a 10-point visual analogue scale exactly at 30 and 60 minutes.
The bupivacaine group had less pain at both 30 minutes (3.2 versus 5.7 points, P = .01) and 60 minutes (2.3 versus 5.9 points, P less than .001); 71% of women in the bupivacaine group had an average score of 4 or less, indicating adequate pain control, versus just 25% in the control arm (P = .003)
“This is something we should be considering” routinely for laparoscopic hysterectomy, an audience member said after hearing the presentation at a meeting sponsored by AAGL.
Another audience member was concerned about urinary retention, but there was no increase in the treatment arm, said lead investigator Steven Radtke, MD, a former ob.gyn. surgery fellow at the university, but now at Texas Tech University, El Paso.
There have been many prior attempts to reduce pain after laparoscopic hysterectomy, such as infiltrating port sites with local anesthetic, but the results have been marginal at best, and almost all of them have focused on the abdominal wall as the source of pain.
The investigators thought that pain was more related to perimetrium dissection, colpotomy, and other parts of the operation. There also have been good studies showing that agents injected into the cervix infuse throughout the area. The team decided to try bupivacaine because it’s inexpensive and has a good duration of action, about 8 hours.
There were no significant demographic or intraoperative differences between the groups. On average, women were in their mid-40s, with a body mass index of about 31 kg/m2. The operations took about 2 hours, and were for benign indications, such as fibroids. Oophorectomy was the only concomitant procedure allowed.
The investigators are interested in repeating their investigation with liposomal bupivacaine (Exparel), which has a duration of action past 24 hours. It’s much more expensive, but the strong trial results justify the cost, Dr. Radtke said.
There was no external funding, and Dr. Radtke didn’t have any disclosures.
SOURCE: Radtke S et al. 2018 AAGL Global Congress, Abstract 130.
LAS VEGAS – according to a small trial at the University of Tennessee, Chattanooga.
Twenty-one women were randomized to 0.5% bupivacaine, 5 mL injected into the cervix at the 3 o’clock position, and 5 mL injected into at the 9 o’clock position to a depth of 3 cm, after anesthesia induction but before insertion of the uterine manipulator. A control group of 20 women received 5 mL of 0.9% saline injected into the same positions. Surgeons were blinded to the randomization.
A stopwatch was started at extubation, and the women were asked to rate their pain on a 10-point visual analogue scale exactly at 30 and 60 minutes.
The bupivacaine group had less pain at both 30 minutes (3.2 versus 5.7 points, P = .01) and 60 minutes (2.3 versus 5.9 points, P less than .001); 71% of women in the bupivacaine group had an average score of 4 or less, indicating adequate pain control, versus just 25% in the control arm (P = .003)
“This is something we should be considering” routinely for laparoscopic hysterectomy, an audience member said after hearing the presentation at a meeting sponsored by AAGL.
Another audience member was concerned about urinary retention, but there was no increase in the treatment arm, said lead investigator Steven Radtke, MD, a former ob.gyn. surgery fellow at the university, but now at Texas Tech University, El Paso.
There have been many prior attempts to reduce pain after laparoscopic hysterectomy, such as infiltrating port sites with local anesthetic, but the results have been marginal at best, and almost all of them have focused on the abdominal wall as the source of pain.
The investigators thought that pain was more related to perimetrium dissection, colpotomy, and other parts of the operation. There also have been good studies showing that agents injected into the cervix infuse throughout the area. The team decided to try bupivacaine because it’s inexpensive and has a good duration of action, about 8 hours.
There were no significant demographic or intraoperative differences between the groups. On average, women were in their mid-40s, with a body mass index of about 31 kg/m2. The operations took about 2 hours, and were for benign indications, such as fibroids. Oophorectomy was the only concomitant procedure allowed.
The investigators are interested in repeating their investigation with liposomal bupivacaine (Exparel), which has a duration of action past 24 hours. It’s much more expensive, but the strong trial results justify the cost, Dr. Radtke said.
There was no external funding, and Dr. Radtke didn’t have any disclosures.
SOURCE: Radtke S et al. 2018 AAGL Global Congress, Abstract 130.
LAS VEGAS – according to a small trial at the University of Tennessee, Chattanooga.
Twenty-one women were randomized to 0.5% bupivacaine, 5 mL injected into the cervix at the 3 o’clock position, and 5 mL injected into at the 9 o’clock position to a depth of 3 cm, after anesthesia induction but before insertion of the uterine manipulator. A control group of 20 women received 5 mL of 0.9% saline injected into the same positions. Surgeons were blinded to the randomization.
A stopwatch was started at extubation, and the women were asked to rate their pain on a 10-point visual analogue scale exactly at 30 and 60 minutes.
The bupivacaine group had less pain at both 30 minutes (3.2 versus 5.7 points, P = .01) and 60 minutes (2.3 versus 5.9 points, P less than .001); 71% of women in the bupivacaine group had an average score of 4 or less, indicating adequate pain control, versus just 25% in the control arm (P = .003)
“This is something we should be considering” routinely for laparoscopic hysterectomy, an audience member said after hearing the presentation at a meeting sponsored by AAGL.
Another audience member was concerned about urinary retention, but there was no increase in the treatment arm, said lead investigator Steven Radtke, MD, a former ob.gyn. surgery fellow at the university, but now at Texas Tech University, El Paso.
There have been many prior attempts to reduce pain after laparoscopic hysterectomy, such as infiltrating port sites with local anesthetic, but the results have been marginal at best, and almost all of them have focused on the abdominal wall as the source of pain.
The investigators thought that pain was more related to perimetrium dissection, colpotomy, and other parts of the operation. There also have been good studies showing that agents injected into the cervix infuse throughout the area. The team decided to try bupivacaine because it’s inexpensive and has a good duration of action, about 8 hours.
There were no significant demographic or intraoperative differences between the groups. On average, women were in their mid-40s, with a body mass index of about 31 kg/m2. The operations took about 2 hours, and were for benign indications, such as fibroids. Oophorectomy was the only concomitant procedure allowed.
The investigators are interested in repeating their investigation with liposomal bupivacaine (Exparel), which has a duration of action past 24 hours. It’s much more expensive, but the strong trial results justify the cost, Dr. Radtke said.
There was no external funding, and Dr. Radtke didn’t have any disclosures.
SOURCE: Radtke S et al. 2018 AAGL Global Congress, Abstract 130.
REPORTING FROM AAGL GLOBAL CONGRESS
Key clinical point: Postoperative pain can be significantly reduced by injecting the cervix with bupivacaine prior to laparoscopic hysterectomy.
Major finding: The bupivacaine group had less pain at both 30 minutes (3.2 versus 5.7 points, P = .01) and 60 minutes (2.3 versus 5.9 points, P less than .001).
Study details: In a randomized study, 21 women received bupivacaine anesthesia and 20 control women were injected with saline.
Disclosures: There was no external funding, and Dr. Radtke didn’t have any disclosures.
Source: Radtke S et al. 2018 AAGL Global Congress, Abstract 130.
Cold packs help reduce pain after laparoscopic hysterectomy
LAS VEGAS – Patients like cold packs for pain control after laparoscopic hysterectomy, according to a small trial from Cleveland Clinic Florida (Weston).
Cold packs have been shown to reduce pain in other types of surgery, so investigators at the clinic wanted to try them out for the procedure, said study lead Pamela Frazzini Padilla, MD, an ob.gyn. at the clinic.
Twenty-eight women were randomized to get packs right after surgery, and told to use them – before turning to oxycodone tabs – every 6 hours for 72 hours – and then as needed. Twenty-eight other women were randomized to the control group. Surgery was for benign indications, most often uterine bleeding secondary to fibroids. Besides the cold packs, there were no differences between the groups in analgesia protocols.
The differences in pain control, assessed on a 10-point scale over the phone, weren’t statistically significant, but they di move in the right direction. At 24 hours, women who were cold pack users reported a median pain score of 4, versus 4.5 among controls. At 72 hours, they reported a median score of 2, versus 2.5 in the control group.
At 2 weeks postoperatively, women who were cold pack users had used a mean of 4 oxycodone pills, versus 7 among the controls, which translated into a mean of 13 IV morphine equivalents versus 24 in favor of cold packs (P = .143).
While not significantly different, overall numbers of opioid tabs consumed and morphine equivalents “demonstrated lower use in the study group,” Dr. Frazzini Padilla noted at the meeting sponsored by AAGL.
Also, 89% of women said that cold packs helped reduce their pain, and 92% said they’d use them again after an operation. “In a day when everything is driven by patient satisfaction, patients’ perception of their recovery” is important. Because cold packs are cheap, harmless, and seemed to help with patient perceptions, “we do recommend that people use” them. “It’s just another added measure that we give” at Cleveland Clinic Florida, she said.
The study team also found that 86% of the women in the trial used 10 or fewer oxycodone tabs after surgery. Across the country, women are prescribed about 25 tabs after a laparoscopic hysterectomy; the study suggests it’s overkill, as an audience member noted, especially given the current climate.
The two arms of the study were well balanced. The mean age was 46 years, and mean body mass index 30.4 kg/m2.
There was no outside funding, and the investigators didn’t have any disclosures.
aotto@mdedge.com
SOURCE: Frazzini Padilla P et al. 2018 AAGL Global Congress, Abstract 21.
LAS VEGAS – Patients like cold packs for pain control after laparoscopic hysterectomy, according to a small trial from Cleveland Clinic Florida (Weston).
Cold packs have been shown to reduce pain in other types of surgery, so investigators at the clinic wanted to try them out for the procedure, said study lead Pamela Frazzini Padilla, MD, an ob.gyn. at the clinic.
Twenty-eight women were randomized to get packs right after surgery, and told to use them – before turning to oxycodone tabs – every 6 hours for 72 hours – and then as needed. Twenty-eight other women were randomized to the control group. Surgery was for benign indications, most often uterine bleeding secondary to fibroids. Besides the cold packs, there were no differences between the groups in analgesia protocols.
The differences in pain control, assessed on a 10-point scale over the phone, weren’t statistically significant, but they di move in the right direction. At 24 hours, women who were cold pack users reported a median pain score of 4, versus 4.5 among controls. At 72 hours, they reported a median score of 2, versus 2.5 in the control group.
At 2 weeks postoperatively, women who were cold pack users had used a mean of 4 oxycodone pills, versus 7 among the controls, which translated into a mean of 13 IV morphine equivalents versus 24 in favor of cold packs (P = .143).
While not significantly different, overall numbers of opioid tabs consumed and morphine equivalents “demonstrated lower use in the study group,” Dr. Frazzini Padilla noted at the meeting sponsored by AAGL.
Also, 89% of women said that cold packs helped reduce their pain, and 92% said they’d use them again after an operation. “In a day when everything is driven by patient satisfaction, patients’ perception of their recovery” is important. Because cold packs are cheap, harmless, and seemed to help with patient perceptions, “we do recommend that people use” them. “It’s just another added measure that we give” at Cleveland Clinic Florida, she said.
The study team also found that 86% of the women in the trial used 10 or fewer oxycodone tabs after surgery. Across the country, women are prescribed about 25 tabs after a laparoscopic hysterectomy; the study suggests it’s overkill, as an audience member noted, especially given the current climate.
The two arms of the study were well balanced. The mean age was 46 years, and mean body mass index 30.4 kg/m2.
There was no outside funding, and the investigators didn’t have any disclosures.
aotto@mdedge.com
SOURCE: Frazzini Padilla P et al. 2018 AAGL Global Congress, Abstract 21.
LAS VEGAS – Patients like cold packs for pain control after laparoscopic hysterectomy, according to a small trial from Cleveland Clinic Florida (Weston).
Cold packs have been shown to reduce pain in other types of surgery, so investigators at the clinic wanted to try them out for the procedure, said study lead Pamela Frazzini Padilla, MD, an ob.gyn. at the clinic.
Twenty-eight women were randomized to get packs right after surgery, and told to use them – before turning to oxycodone tabs – every 6 hours for 72 hours – and then as needed. Twenty-eight other women were randomized to the control group. Surgery was for benign indications, most often uterine bleeding secondary to fibroids. Besides the cold packs, there were no differences between the groups in analgesia protocols.
The differences in pain control, assessed on a 10-point scale over the phone, weren’t statistically significant, but they di move in the right direction. At 24 hours, women who were cold pack users reported a median pain score of 4, versus 4.5 among controls. At 72 hours, they reported a median score of 2, versus 2.5 in the control group.
At 2 weeks postoperatively, women who were cold pack users had used a mean of 4 oxycodone pills, versus 7 among the controls, which translated into a mean of 13 IV morphine equivalents versus 24 in favor of cold packs (P = .143).
While not significantly different, overall numbers of opioid tabs consumed and morphine equivalents “demonstrated lower use in the study group,” Dr. Frazzini Padilla noted at the meeting sponsored by AAGL.
Also, 89% of women said that cold packs helped reduce their pain, and 92% said they’d use them again after an operation. “In a day when everything is driven by patient satisfaction, patients’ perception of their recovery” is important. Because cold packs are cheap, harmless, and seemed to help with patient perceptions, “we do recommend that people use” them. “It’s just another added measure that we give” at Cleveland Clinic Florida, she said.
The study team also found that 86% of the women in the trial used 10 or fewer oxycodone tabs after surgery. Across the country, women are prescribed about 25 tabs after a laparoscopic hysterectomy; the study suggests it’s overkill, as an audience member noted, especially given the current climate.
The two arms of the study were well balanced. The mean age was 46 years, and mean body mass index 30.4 kg/m2.
There was no outside funding, and the investigators didn’t have any disclosures.
aotto@mdedge.com
SOURCE: Frazzini Padilla P et al. 2018 AAGL Global Congress, Abstract 21.
REPORTING FROM AAGL GLOBAL CONGRESS
Key clinical point:
Major finding: Cold pack women at 2 weeks used a mean of 4 oxycodone pills, versus 7 among the controls, which translated into a mean of 13 IV morphine equivalents versus 24 in favor of cold packs (P = 0.143)
Study details: A study of 28 women using cold packs and 28 controls.
Disclosures: There was no outside funding, and the investigators didn’t have any disclosures.
Source: Frazzini Padilla P et al. 2018 AAGL Global Congress, Abstract 21.
Laparoscope doubles as cystoscope in robotic hysterectomy
LAS VEGAS – to check for injuries, according to a review from St. Joseph’s University Medical Center, in Paterson, N.J.
Postoperative urinary tract infections (UTIs) are the big worry with using the same scope, but they really weren’t a problem at St. Joe’s; in a study of 45 women, there was just one UTI, confirmed by culture, at the 2-week postoperative visit, yielding a rate (2.2%) that is actually better the 5%-10% reported for stand-alone cystoscopy, said lead investigator and ob.gyn. resident Nikki Amirlatifi, MD.
“This is a safe alternative to traditional cystoscopy. We had no problems with visualization, and it doesn’t increase the rate of UTIs. Of course, it’s not only cost saving but time saving, as well,” she said.
The cases all were routine, however. For tougher ones, “where we need a more in-depth look at the bladder, we would [still] do cystoscopy,” she said at the meeting sponsored by AAGL.
There’s some debate about routine cystoscopy during laparoscopic hysterectomy, but Dr. Amirlatifi noted that it’s been reported to detect up to 89% of ureter injuries and up to 95% of bladder injuries. Using the same scope for both procedures makes it easier.
After the uterus was taken out, the bladder was backfilled with 180 mL of sterile water, then the Foley catheter was pulled. The previously used 5 mm laparoscope, which had been used for abdominal entry at 0 degrees, was introduced into the bladder. Efflux from both ureteral orifices was visualized, then the catheter reinserted until the end of surgery.
The women were an average of 44 years old, with an average body mass index of 32 kg/m2. Abnormal uterine bleeding, pelvic pain, and fibroids were the main indications for surgery. No ureteral or bladder injuries were detected.
Everyone was questioned about UTI symptoms and gave a clean-catch urine sample at the first postoperative visit. Cultures were performed on the seven women who reported symptoms or had white cells in their sample, and they were treated empirically with antibiotics. Only one culture grew out despite a high prevalence of UTI risk factors, including diabetes (13%), obesity (42%), and smoking (11%).
All the women had preoperative antibiotics and phenazopyridine. Most went home on the day of surgery.
There was no outside funding for the work, and the investigators didn’t have any relevant financial disclosures.
SOURCE: J Minim. Invasive Gynecol. 2018 Nov-Dec;25[7]:S46-47.
LAS VEGAS – to check for injuries, according to a review from St. Joseph’s University Medical Center, in Paterson, N.J.
Postoperative urinary tract infections (UTIs) are the big worry with using the same scope, but they really weren’t a problem at St. Joe’s; in a study of 45 women, there was just one UTI, confirmed by culture, at the 2-week postoperative visit, yielding a rate (2.2%) that is actually better the 5%-10% reported for stand-alone cystoscopy, said lead investigator and ob.gyn. resident Nikki Amirlatifi, MD.
“This is a safe alternative to traditional cystoscopy. We had no problems with visualization, and it doesn’t increase the rate of UTIs. Of course, it’s not only cost saving but time saving, as well,” she said.
The cases all were routine, however. For tougher ones, “where we need a more in-depth look at the bladder, we would [still] do cystoscopy,” she said at the meeting sponsored by AAGL.
There’s some debate about routine cystoscopy during laparoscopic hysterectomy, but Dr. Amirlatifi noted that it’s been reported to detect up to 89% of ureter injuries and up to 95% of bladder injuries. Using the same scope for both procedures makes it easier.
After the uterus was taken out, the bladder was backfilled with 180 mL of sterile water, then the Foley catheter was pulled. The previously used 5 mm laparoscope, which had been used for abdominal entry at 0 degrees, was introduced into the bladder. Efflux from both ureteral orifices was visualized, then the catheter reinserted until the end of surgery.
The women were an average of 44 years old, with an average body mass index of 32 kg/m2. Abnormal uterine bleeding, pelvic pain, and fibroids were the main indications for surgery. No ureteral or bladder injuries were detected.
Everyone was questioned about UTI symptoms and gave a clean-catch urine sample at the first postoperative visit. Cultures were performed on the seven women who reported symptoms or had white cells in their sample, and they were treated empirically with antibiotics. Only one culture grew out despite a high prevalence of UTI risk factors, including diabetes (13%), obesity (42%), and smoking (11%).
All the women had preoperative antibiotics and phenazopyridine. Most went home on the day of surgery.
There was no outside funding for the work, and the investigators didn’t have any relevant financial disclosures.
SOURCE: J Minim. Invasive Gynecol. 2018 Nov-Dec;25[7]:S46-47.
LAS VEGAS – to check for injuries, according to a review from St. Joseph’s University Medical Center, in Paterson, N.J.
Postoperative urinary tract infections (UTIs) are the big worry with using the same scope, but they really weren’t a problem at St. Joe’s; in a study of 45 women, there was just one UTI, confirmed by culture, at the 2-week postoperative visit, yielding a rate (2.2%) that is actually better the 5%-10% reported for stand-alone cystoscopy, said lead investigator and ob.gyn. resident Nikki Amirlatifi, MD.
“This is a safe alternative to traditional cystoscopy. We had no problems with visualization, and it doesn’t increase the rate of UTIs. Of course, it’s not only cost saving but time saving, as well,” she said.
The cases all were routine, however. For tougher ones, “where we need a more in-depth look at the bladder, we would [still] do cystoscopy,” she said at the meeting sponsored by AAGL.
There’s some debate about routine cystoscopy during laparoscopic hysterectomy, but Dr. Amirlatifi noted that it’s been reported to detect up to 89% of ureter injuries and up to 95% of bladder injuries. Using the same scope for both procedures makes it easier.
After the uterus was taken out, the bladder was backfilled with 180 mL of sterile water, then the Foley catheter was pulled. The previously used 5 mm laparoscope, which had been used for abdominal entry at 0 degrees, was introduced into the bladder. Efflux from both ureteral orifices was visualized, then the catheter reinserted until the end of surgery.
The women were an average of 44 years old, with an average body mass index of 32 kg/m2. Abnormal uterine bleeding, pelvic pain, and fibroids were the main indications for surgery. No ureteral or bladder injuries were detected.
Everyone was questioned about UTI symptoms and gave a clean-catch urine sample at the first postoperative visit. Cultures were performed on the seven women who reported symptoms or had white cells in their sample, and they were treated empirically with antibiotics. Only one culture grew out despite a high prevalence of UTI risk factors, including diabetes (13%), obesity (42%), and smoking (11%).
All the women had preoperative antibiotics and phenazopyridine. Most went home on the day of surgery.
There was no outside funding for the work, and the investigators didn’t have any relevant financial disclosures.
SOURCE: J Minim. Invasive Gynecol. 2018 Nov-Dec;25[7]:S46-47.
REPORTING FROM AAGL GLOBAL CONGRESS
Key clinical point: It is just as safe to look inside the bladder with the laparoscope after robotic hysterectomy in routine cases as to use a separate cystoscopy setup.
Major finding: Only 2.2% of women had a UTI, and there were no ureteral or bladder injuries detected using the laparoscope.
Study details: This was a prospective study of 45 women who underwent robotic hysterectomy whose bladder was inspected with the laparoscope at the end of surgery.
Disclosures: There was no outside funding for the work, and the investigators didn’t have any relevant financial disclosures.
Laparoscopic hysterectomy with obliterated cul-de-sac needs specialist care
LAS VEGAS – When stage IV endometriosis with obliterated posterior cul-de-sac is discovered during laparoscopic hysterectomy, or suspected beforehand, women should be referred to a minimally invasive gynecologic surgery specialist because the procedure will be much more difficult, investigators said at the meeting sponsored by AAGL.
They reviewed 333 laparoscopic hysterectomies where endometriosis was discovered in the operating room. The disease is known to increase the complexity of hysterectomy; the investigators wanted to quantify the risk by endometriosis severity. Among their subjects, 237 women (71%) had stage I, II, or III endometriosis; 96 (29%) had stage IV disease, including 55 women (57%) with obliterated posterior cul-de-sacs.
Surgery was longer among stage IV cases (137 vs. 116 minutes), and there was greater blood loss; 66% of stage IV women required laparoscopic-modified radical hysterectomy versus about a quarter of women with stage I-III endometriosis.
A total of 93% required modified radical hysterectomies versus 29% of stage IV women with intact cul-de-sacs. Additional procedures were far more likely in this population, including salpingectomy, ureterolysis, enterolysis, cystoscopy, ureteral stenting, proctoscopy, bowel oversew, and anterior resection anastomosis. The differences all were statistically significant.
Among stage IV cases, mean operating time was longer in obliterated cul-de-sac cases (159 vs. 108 minutes), with higher blood loss, 100 mL versus 50 mL.
“Patients with obliterated cul-de-sacs identified intraoperatively should be referred to minimally invasive gynecologic surgeons because of the ... extra training required to safely perform [laparoscopic hysterectomy] with limited morbidity,” said lead investigator Alexandra Melnyk, MD, a University of Pittsburgh ob.gyn resident.
There was no industry funding and the investigators reported no disclosures.
SOURCE: Melnyk A et al. 2018 AAGL Global Congress, Abstract 81.
LAS VEGAS – When stage IV endometriosis with obliterated posterior cul-de-sac is discovered during laparoscopic hysterectomy, or suspected beforehand, women should be referred to a minimally invasive gynecologic surgery specialist because the procedure will be much more difficult, investigators said at the meeting sponsored by AAGL.
They reviewed 333 laparoscopic hysterectomies where endometriosis was discovered in the operating room. The disease is known to increase the complexity of hysterectomy; the investigators wanted to quantify the risk by endometriosis severity. Among their subjects, 237 women (71%) had stage I, II, or III endometriosis; 96 (29%) had stage IV disease, including 55 women (57%) with obliterated posterior cul-de-sacs.
Surgery was longer among stage IV cases (137 vs. 116 minutes), and there was greater blood loss; 66% of stage IV women required laparoscopic-modified radical hysterectomy versus about a quarter of women with stage I-III endometriosis.
A total of 93% required modified radical hysterectomies versus 29% of stage IV women with intact cul-de-sacs. Additional procedures were far more likely in this population, including salpingectomy, ureterolysis, enterolysis, cystoscopy, ureteral stenting, proctoscopy, bowel oversew, and anterior resection anastomosis. The differences all were statistically significant.
Among stage IV cases, mean operating time was longer in obliterated cul-de-sac cases (159 vs. 108 minutes), with higher blood loss, 100 mL versus 50 mL.
“Patients with obliterated cul-de-sacs identified intraoperatively should be referred to minimally invasive gynecologic surgeons because of the ... extra training required to safely perform [laparoscopic hysterectomy] with limited morbidity,” said lead investigator Alexandra Melnyk, MD, a University of Pittsburgh ob.gyn resident.
There was no industry funding and the investigators reported no disclosures.
SOURCE: Melnyk A et al. 2018 AAGL Global Congress, Abstract 81.
LAS VEGAS – When stage IV endometriosis with obliterated posterior cul-de-sac is discovered during laparoscopic hysterectomy, or suspected beforehand, women should be referred to a minimally invasive gynecologic surgery specialist because the procedure will be much more difficult, investigators said at the meeting sponsored by AAGL.
They reviewed 333 laparoscopic hysterectomies where endometriosis was discovered in the operating room. The disease is known to increase the complexity of hysterectomy; the investigators wanted to quantify the risk by endometriosis severity. Among their subjects, 237 women (71%) had stage I, II, or III endometriosis; 96 (29%) had stage IV disease, including 55 women (57%) with obliterated posterior cul-de-sacs.
Surgery was longer among stage IV cases (137 vs. 116 minutes), and there was greater blood loss; 66% of stage IV women required laparoscopic-modified radical hysterectomy versus about a quarter of women with stage I-III endometriosis.
A total of 93% required modified radical hysterectomies versus 29% of stage IV women with intact cul-de-sacs. Additional procedures were far more likely in this population, including salpingectomy, ureterolysis, enterolysis, cystoscopy, ureteral stenting, proctoscopy, bowel oversew, and anterior resection anastomosis. The differences all were statistically significant.
Among stage IV cases, mean operating time was longer in obliterated cul-de-sac cases (159 vs. 108 minutes), with higher blood loss, 100 mL versus 50 mL.
“Patients with obliterated cul-de-sacs identified intraoperatively should be referred to minimally invasive gynecologic surgeons because of the ... extra training required to safely perform [laparoscopic hysterectomy] with limited morbidity,” said lead investigator Alexandra Melnyk, MD, a University of Pittsburgh ob.gyn resident.
There was no industry funding and the investigators reported no disclosures.
SOURCE: Melnyk A et al. 2018 AAGL Global Congress, Abstract 81.
REPORTING FROM THE AAGL GLOBAL CONGRESS