General Surgery

CHICAGO – Surgical outcomes of acute, complicated diverticulitis are equivalent regardless of whether a colorectal or general surgeon wields the scalpel, a multicenter study showed.

There was no difference between the colorectal surgery (CRS) and general surgery groups for the primary outcomes of 90-day morbidity (26% vs 28%; P = .76), readmission (32% vs. 25%; P = .48), and length of stay (both median 9 days; P = .82).

Patrice Wendling/Frontline Medical News

Surgeon specialization was not associated with any of the outcomes in multivariate regression that accounted for patient demographics, surgeon type, and disease characteristics, study author Capt. G. Paul Wright, U.S. Army Reserve Medical Corps, reported at the annual meeting of the Central Surgical Association.

The authors tackled the controversial issue in light of recent data suggesting improved acute, complicated diverticulitis surgery outcomes in the hands of specialized surgeons. A 2014 study reported that colorectal surgeons were less likely than general surgeons to use a Hartmann’s procedure and had reduced LOS and time to stoma reversal (J. Am. Coll. Surg. 2014;218:1156-61).

The current analysis involved 115 consecutive patients with acute, complicated diverticulitis who underwent emergent surgery with either a colorectal surgeon (n = 62) or general surgeon (n = 53) at two university-affiliated hospitals from 2006 to 2013. Age, Charlson Comorbidity Index, and American Society of Anesthesiologists class were similar between groups.

The colorectal surgeon group (CRS), however, was significantly more likely to have had previous episodes of diverticulitis (58% vs. 25%; P < .001), likely representing a referral bias or preexisting relationship with their surgeon, Dr. Wright said.

The general surgeon (GS) group had a significantly higher number of Systemic Inflammatory Response Syndrome criteria (P = .009 for all groups), higher rates of Hinchey class 3 disease (59% vs. 32%: P = .02), and ICU admissions (25% vs. 7%; P = .006).

The most common procedure among general surgeons was a Hartmann’s procedure (64% vs. 34%; P < .001), whereas colorectal surgeons favored primary anastomosis with diverting ileostomy (45% vs. 0%; P < .001), Dr. Wright, from Grand Rapids Medical Education Partners and Michigan State University, both in Grand Rapids, reported.

General surgeons were more likely to close the skin (85% vs. 50%), while in the CRS group the skin was left partially or completely open in 50% of patients. Operative time at the index admission was an average of 36 minutes longer in the CRS group (mean 164 minutes vs. 128 minutes; P = .005).

The CRS group had a higher rate of stoma reversal (78% vs 65%) and shorter time to stoma reversal (4 months vs. 4.7 months), but the difference was not statistically significant. The CRS group had a significantly shorter stoma reversal OR duration (mean 106 minutes vs. 182 minutes; P = .0010) and stoma reversal length of stay (mean 4 days vs. 7 days; P < .001).

“As general surgeons will no doubt continue to care for acute diverticulitis, increased use of primary anastomosis with proximal diversion when appropriate may be warranted due to the secondary benefits seen in stoma reversal,” Dr. Wright said.

Mortality was low and similar, at just one death in the CRS and two in the GS group.

Invited discussant William Cirocco, from Ohio State University in Columbus, said the type of surgical intervention is just one aspect in the management of patients with diverticulitis.

“An additional nonoperative approach may lead to conversion of an emergent to a nonemergent single-stage dissection. These critical decisions require experience and training,” Dr. Cirocco said. “For patients who require emergent operation for diffuse peritonitis, I believe that background and experience of the individual surgeon trumps the presence or absence of specialty training.”

Dr. Wright and his coauthors reported having no financial conflicts.

pwendling@frontlinemedcom.com

CHICAGO – Surgical outcomes of acute, complicated diverticulitis are equivalent regardless of whether a colorectal or general surgeon wields the scalpel, a multicenter study showed.

There was no difference between the colorectal surgery (CRS) and general surgery groups for the primary outcomes of 90-day morbidity (26% vs 28%; P = .76), readmission (32% vs. 25%; P = .48), and length of stay (both median 9 days; P = .82).

Patrice Wendling/Frontline Medical News

Surgeon specialization was not associated with any of the outcomes in multivariate regression that accounted for patient demographics, surgeon type, and disease characteristics, study author Capt. G. Paul Wright, U.S. Army Reserve Medical Corps, reported at the annual meeting of the Central Surgical Association.

The authors tackled the controversial issue in light of recent data suggesting improved acute, complicated diverticulitis surgery outcomes in the hands of specialized surgeons. A 2014 study reported that colorectal surgeons were less likely than general surgeons to use a Hartmann’s procedure and had reduced LOS and time to stoma reversal (J. Am. Coll. Surg. 2014;218:1156-61).

The current analysis involved 115 consecutive patients with acute, complicated diverticulitis who underwent emergent surgery with either a colorectal surgeon (n = 62) or general surgeon (n = 53) at two university-affiliated hospitals from 2006 to 2013. Age, Charlson Comorbidity Index, and American Society of Anesthesiologists class were similar between groups.

The colorectal surgeon group (CRS), however, was significantly more likely to have had previous episodes of diverticulitis (58% vs. 25%; P < .001), likely representing a referral bias or preexisting relationship with their surgeon, Dr. Wright said.

The general surgeon (GS) group had a significantly higher number of Systemic Inflammatory Response Syndrome criteria (P = .009 for all groups), higher rates of Hinchey class 3 disease (59% vs. 32%: P = .02), and ICU admissions (25% vs. 7%; P = .006).

The most common procedure among general surgeons was a Hartmann’s procedure (64% vs. 34%; P < .001), whereas colorectal surgeons favored primary anastomosis with diverting ileostomy (45% vs. 0%; P < .001), Dr. Wright, from Grand Rapids Medical Education Partners and Michigan State University, both in Grand Rapids, reported.

General surgeons were more likely to close the skin (85% vs. 50%), while in the CRS group the skin was left partially or completely open in 50% of patients. Operative time at the index admission was an average of 36 minutes longer in the CRS group (mean 164 minutes vs. 128 minutes; P = .005).

The CRS group had a higher rate of stoma reversal (78% vs 65%) and shorter time to stoma reversal (4 months vs. 4.7 months), but the difference was not statistically significant. The CRS group had a significantly shorter stoma reversal OR duration (mean 106 minutes vs. 182 minutes; P = .0010) and stoma reversal length of stay (mean 4 days vs. 7 days; P < .001).

“As general surgeons will no doubt continue to care for acute diverticulitis, increased use of primary anastomosis with proximal diversion when appropriate may be warranted due to the secondary benefits seen in stoma reversal,” Dr. Wright said.

Mortality was low and similar, at just one death in the CRS and two in the GS group.

Invited discussant William Cirocco, from Ohio State University in Columbus, said the type of surgical intervention is just one aspect in the management of patients with diverticulitis.

“An additional nonoperative approach may lead to conversion of an emergent to a nonemergent single-stage dissection. These critical decisions require experience and training,” Dr. Cirocco said. “For patients who require emergent operation for diffuse peritonitis, I believe that background and experience of the individual surgeon trumps the presence or absence of specialty training.”

Dr. Wright and his coauthors reported having no financial conflicts.

pwendling@frontlinemedcom.com

CHICAGO – Surgical outcomes of acute, complicated diverticulitis are equivalent regardless of whether a colorectal or general surgeon wields the scalpel, a multicenter study showed.

There was no difference between the colorectal surgery (CRS) and general surgery groups for the primary outcomes of 90-day morbidity (26% vs 28%; P = .76), readmission (32% vs. 25%; P = .48), and length of stay (both median 9 days; P = .82).

Patrice Wendling/Frontline Medical News

Surgeon specialization was not associated with any of the outcomes in multivariate regression that accounted for patient demographics, surgeon type, and disease characteristics, study author Capt. G. Paul Wright, U.S. Army Reserve Medical Corps, reported at the annual meeting of the Central Surgical Association.

The authors tackled the controversial issue in light of recent data suggesting improved acute, complicated diverticulitis surgery outcomes in the hands of specialized surgeons. A 2014 study reported that colorectal surgeons were less likely than general surgeons to use a Hartmann’s procedure and had reduced LOS and time to stoma reversal (J. Am. Coll. Surg. 2014;218:1156-61).

The current analysis involved 115 consecutive patients with acute, complicated diverticulitis who underwent emergent surgery with either a colorectal surgeon (n = 62) or general surgeon (n = 53) at two university-affiliated hospitals from 2006 to 2013. Age, Charlson Comorbidity Index, and American Society of Anesthesiologists class were similar between groups.

The colorectal surgeon group (CRS), however, was significantly more likely to have had previous episodes of diverticulitis (58% vs. 25%; P < .001), likely representing a referral bias or preexisting relationship with their surgeon, Dr. Wright said.

The general surgeon (GS) group had a significantly higher number of Systemic Inflammatory Response Syndrome criteria (P = .009 for all groups), higher rates of Hinchey class 3 disease (59% vs. 32%: P = .02), and ICU admissions (25% vs. 7%; P = .006).

The most common procedure among general surgeons was a Hartmann’s procedure (64% vs. 34%; P < .001), whereas colorectal surgeons favored primary anastomosis with diverting ileostomy (45% vs. 0%; P < .001), Dr. Wright, from Grand Rapids Medical Education Partners and Michigan State University, both in Grand Rapids, reported.

General surgeons were more likely to close the skin (85% vs. 50%), while in the CRS group the skin was left partially or completely open in 50% of patients. Operative time at the index admission was an average of 36 minutes longer in the CRS group (mean 164 minutes vs. 128 minutes; P = .005).

The CRS group had a higher rate of stoma reversal (78% vs 65%) and shorter time to stoma reversal (4 months vs. 4.7 months), but the difference was not statistically significant. The CRS group had a significantly shorter stoma reversal OR duration (mean 106 minutes vs. 182 minutes; P = .0010) and stoma reversal length of stay (mean 4 days vs. 7 days; P < .001).

“As general surgeons will no doubt continue to care for acute diverticulitis, increased use of primary anastomosis with proximal diversion when appropriate may be warranted due to the secondary benefits seen in stoma reversal,” Dr. Wright said.

Mortality was low and similar, at just one death in the CRS and two in the GS group.

Invited discussant William Cirocco, from Ohio State University in Columbus, said the type of surgical intervention is just one aspect in the management of patients with diverticulitis.

“An additional nonoperative approach may lead to conversion of an emergent to a nonemergent single-stage dissection. These critical decisions require experience and training,” Dr. Cirocco said. “For patients who require emergent operation for diffuse peritonitis, I believe that background and experience of the individual surgeon trumps the presence or absence of specialty training.”

Dr. Wright and his coauthors reported having no financial conflicts.

pwendling@frontlinemedcom.com

Laparoscopic sleeve gastrectomy is associated with lower rates of morbidity and similar mortality when compared with laparoscopic Roux-en-Y gastric bypass, according to an analysis of 2010-2011 data from the American College of Surgeons National Surgical Quality Improvement Program database.

Of 24,117 patients included in the analysis, 79.5% underwent laparoscopic Roux-en-Y gastric bypass (LGB), and 20.5% had laparoscopic sleeve gastrectomy (LSG). Of note, the proportion of LSG cases increased from 14.6% in 2010 to 24.8% in 2011, Dr. Monica T. Young of the University of California Irvine Medical Center, Orange, Calif., and her colleagues reported.

©Thinkstock.com

Those who underwent LGB had a significantly higher rate of 30-day risk-adjusted morbidity (odds ratio, 1.32). The 30-day mortality rate was 0.15% with bypass and 0.10% for sleeve gastrectomy, the investigators said (J. Am. Coll. Surg. 2015 [doi:
10.1016/j.jamcollsurg.2015.01.059]).

Further, sleeve gastrectomy was associated with shorter operative time (101 vs. 133 minutes) and with lower rates of blood loss requiring transfusion (0.65% vs. 1.5%), deep wound infections (0.06% vs. 0.20%), sepsis (0.34% vs. 0.58%), overall serious morbidity (3.8% vs. 5.8%), and reoperations within 30 days (1.6% vs. 2.5%).

The rate of deep venous thrombosis, however, was significantly higher with sleeve gastrectomy (0.47% vs. 0.21%). Deep vein thrombosis was the only complication found to be higher after LSG, they noted.

Older patients, those with a higher body mass index, and those who smoked or had hypertension were at significantly greater risk of serious morbidity.

Given the increasing popularity and use of sleeve gastrectomy as seen both in this study and nationally – with a reported increase in utilization from 0.9% in 2008 to 36.3% in 2012, it is important to compare outcomes with LSG with those for the preferred Roux-en-Y bypass surgery, the investigators said, noting that few large-scale studies have compared outcomes with the two procedures.

“Over the past decade, laparoscopic sleeve gastrectomy has emerged as a common utilized bariatric procedure. LSG has several advantages over LGB including preservation of endoscopic access to the upper gastrointestinal tract, avoidance of intestinal anastomosis, and prevention of dumping syndrome by pylorus preservation,” they wrote, adding that studies increasingly demonstrate its efficacy for weight loss.

The current findings support those of other recent studies, and a comparison of the data with those from 2007 to 2010 from the ACS NSQIP database showed that while reoperation rates after gastric bypass and sleeve gastrectomy have declined dramatically over time, readmission rates remain elevated.

“Therefore, it appears that further quality improvement initiatives are necessary to reduce the rate of readmissions after bariatric surgery,” the investigators wrote, noting that a national collaborative to reduce 30-day readmissions by 20% (the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, or MBSAQIP) is currently enrolling.

Additional randomized controlled trials are also needed to evaluate differences in long-term outcomes between the two procedures, they concluded.

The authors reported having no relevant financial disclosures.

Laparoscopic sleeve gastrectomy is associated with lower rates of morbidity and similar mortality when compared with laparoscopic Roux-en-Y gastric bypass, according to an analysis of 2010-2011 data from the American College of Surgeons National Surgical Quality Improvement Program database.

Of 24,117 patients included in the analysis, 79.5% underwent laparoscopic Roux-en-Y gastric bypass (LGB), and 20.5% had laparoscopic sleeve gastrectomy (LSG). Of note, the proportion of LSG cases increased from 14.6% in 2010 to 24.8% in 2011, Dr. Monica T. Young of the University of California Irvine Medical Center, Orange, Calif., and her colleagues reported.

©Thinkstock.com

Those who underwent LGB had a significantly higher rate of 30-day risk-adjusted morbidity (odds ratio, 1.32). The 30-day mortality rate was 0.15% with bypass and 0.10% for sleeve gastrectomy, the investigators said (J. Am. Coll. Surg. 2015 [doi:
10.1016/j.jamcollsurg.2015.01.059]).

Further, sleeve gastrectomy was associated with shorter operative time (101 vs. 133 minutes) and with lower rates of blood loss requiring transfusion (0.65% vs. 1.5%), deep wound infections (0.06% vs. 0.20%), sepsis (0.34% vs. 0.58%), overall serious morbidity (3.8% vs. 5.8%), and reoperations within 30 days (1.6% vs. 2.5%).

The rate of deep venous thrombosis, however, was significantly higher with sleeve gastrectomy (0.47% vs. 0.21%). Deep vein thrombosis was the only complication found to be higher after LSG, they noted.

Older patients, those with a higher body mass index, and those who smoked or had hypertension were at significantly greater risk of serious morbidity.

Given the increasing popularity and use of sleeve gastrectomy as seen both in this study and nationally – with a reported increase in utilization from 0.9% in 2008 to 36.3% in 2012, it is important to compare outcomes with LSG with those for the preferred Roux-en-Y bypass surgery, the investigators said, noting that few large-scale studies have compared outcomes with the two procedures.

“Over the past decade, laparoscopic sleeve gastrectomy has emerged as a common utilized bariatric procedure. LSG has several advantages over LGB including preservation of endoscopic access to the upper gastrointestinal tract, avoidance of intestinal anastomosis, and prevention of dumping syndrome by pylorus preservation,” they wrote, adding that studies increasingly demonstrate its efficacy for weight loss.

The current findings support those of other recent studies, and a comparison of the data with those from 2007 to 2010 from the ACS NSQIP database showed that while reoperation rates after gastric bypass and sleeve gastrectomy have declined dramatically over time, readmission rates remain elevated.

“Therefore, it appears that further quality improvement initiatives are necessary to reduce the rate of readmissions after bariatric surgery,” the investigators wrote, noting that a national collaborative to reduce 30-day readmissions by 20% (the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, or MBSAQIP) is currently enrolling.

Additional randomized controlled trials are also needed to evaluate differences in long-term outcomes between the two procedures, they concluded.

The authors reported having no relevant financial disclosures.

Laparoscopic sleeve gastrectomy is associated with lower rates of morbidity and similar mortality when compared with laparoscopic Roux-en-Y gastric bypass, according to an analysis of 2010-2011 data from the American College of Surgeons National Surgical Quality Improvement Program database.

Of 24,117 patients included in the analysis, 79.5% underwent laparoscopic Roux-en-Y gastric bypass (LGB), and 20.5% had laparoscopic sleeve gastrectomy (LSG). Of note, the proportion of LSG cases increased from 14.6% in 2010 to 24.8% in 2011, Dr. Monica T. Young of the University of California Irvine Medical Center, Orange, Calif., and her colleagues reported.

©Thinkstock.com

Those who underwent LGB had a significantly higher rate of 30-day risk-adjusted morbidity (odds ratio, 1.32). The 30-day mortality rate was 0.15% with bypass and 0.10% for sleeve gastrectomy, the investigators said (J. Am. Coll. Surg. 2015 [doi:
10.1016/j.jamcollsurg.2015.01.059]).

Further, sleeve gastrectomy was associated with shorter operative time (101 vs. 133 minutes) and with lower rates of blood loss requiring transfusion (0.65% vs. 1.5%), deep wound infections (0.06% vs. 0.20%), sepsis (0.34% vs. 0.58%), overall serious morbidity (3.8% vs. 5.8%), and reoperations within 30 days (1.6% vs. 2.5%).

The rate of deep venous thrombosis, however, was significantly higher with sleeve gastrectomy (0.47% vs. 0.21%). Deep vein thrombosis was the only complication found to be higher after LSG, they noted.

Older patients, those with a higher body mass index, and those who smoked or had hypertension were at significantly greater risk of serious morbidity.

Given the increasing popularity and use of sleeve gastrectomy as seen both in this study and nationally – with a reported increase in utilization from 0.9% in 2008 to 36.3% in 2012, it is important to compare outcomes with LSG with those for the preferred Roux-en-Y bypass surgery, the investigators said, noting that few large-scale studies have compared outcomes with the two procedures.

“Over the past decade, laparoscopic sleeve gastrectomy has emerged as a common utilized bariatric procedure. LSG has several advantages over LGB including preservation of endoscopic access to the upper gastrointestinal tract, avoidance of intestinal anastomosis, and prevention of dumping syndrome by pylorus preservation,” they wrote, adding that studies increasingly demonstrate its efficacy for weight loss.

The current findings support those of other recent studies, and a comparison of the data with those from 2007 to 2010 from the ACS NSQIP database showed that while reoperation rates after gastric bypass and sleeve gastrectomy have declined dramatically over time, readmission rates remain elevated.

“Therefore, it appears that further quality improvement initiatives are necessary to reduce the rate of readmissions after bariatric surgery,” the investigators wrote, noting that a national collaborative to reduce 30-day readmissions by 20% (the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, or MBSAQIP) is currently enrolling.

Additional randomized controlled trials are also needed to evaluate differences in long-term outcomes between the two procedures, they concluded.

The authors reported having no relevant financial disclosures.

CHICAGO – Patients who underwent modified laparoscopic Sugarbaker parastomal hernia repair were a third less likely to experience recurrence as those repaired with other surgical techniques in a multicenter, retrospective study in 62 patients.

The recurrence rate was 16.6% for the modified Sugarbaker technique, compared with 61% for keyhole repair, 69.2% for ostomy relocation, and 33.3% for open repair (P value < .001). Median follow-up was 16.6 months, 19.6 months, 16.4 months, and 27.2 months (P = .748).

In an adjusted Cox proportional hazards regression model, the Sugarbaker technique (hazard ratio, 0.28; P = .021) and body mass index (HR, 1.09; P = .013) were the only significant predictors of time to hernia recurrence.

Using the Kaplan-Meier method, 80% of Sugarbaker patients would be recurrence free at 2 years vs. about 60% of those in the other groups (log-rank P = .021), Mr. Francis DeAsis, a research assistant from NorthShore University Health in Evanston, Ill., reported at the annual meeting of the Central Surgical Association.

The findings are in keeping with prior Sugarbaker studies involving 177 repairs between 2005 and 2013, reporting recurrence rates between 4% and 20% and morbidity of 12%-43%, he said.

Morbidity was 40% among the 25 Sugarbaker repairs in the current analysis, significantly lower than that in the Keyhole, relocation, and open repair groups (40% vs. 83.3%, 61.5%, 83.3%; P = .005).

“Based on our results and others, we’d like to suggest that the Sugarbaker approach should be the primary option for treating parastomal hernia,” Mr. DeAsis said.

The study provides “further proof that no other technique available results in a durable repair compared to the Sugarbaker technique for these challenging hernias,” senior study author Dr. Michael Ujiki, director of minimally invasive surgery at NorthShore, said in an interview.

The Sugarbaker technique typically involves a laparoscopic mesh sublay over the fascial defect and lateralization of the stoma limb. Modifications at NorthShore included use of polytetrafluoroethylene mesh with a 5-cm overlap of the defect and, if possible, primary closure of the defect. A catheter is occasionally used to identify the correct ostomy limb, but most importantly, a laparoscopic approach is utilized in order to decrease wound infections and quicken the return to daily activities, Dr. Ujiki said. “We also avoid cautery and diligently look for other incidental hernias at the prevision incisions.”

Ileus (> 3 days) was the most common complication in all groups: Sugarbaker (4/25), keyhole (9/18), relocation (3/13), and open (1/6). Only one death occurred; in the open group.

Discussant Dr. Matthew Goldblatt, with the Medical College of Wisconsin in Milwaukee, questioned how many patients also had ventral hernias and whether this was a complicating factor in ileus or length of stay and whether the fascia was closed primarily during keyhole repair or the mesh simply placed as a bridge, as this can impact failure rates.

Dr. Ujiki responded that some patients had concomitant ventral hernias and that they simply used a larger piece of mesh to cover both hernias. Primary closure was not part of the keyhole repair early in the 10-year series, spanning 2004 to 2014, but ultimately was performed in about half of patients in the keyhole group.

“I don’t think that there’s going to be a difference between the two in terms of recurrence, but I can’t say for sure,” he added.

At this point, the group does not use prophylactic mesh placement at the time the ostomy is created, to avoid infections.

Finally, the audience asked whether the investigators are willing to accept a 16% recurrence rate, a fourfold increase over the best reported result with a modified Sugarbaker technique.

“With these hernia repairs, to me a 16% recurrence rate is outstanding and I think it will only get better,” Dr. Ujiki said.

The series includes every patient on which they’ve performed a Sugarbaker and thus, represents their learning curve, which may not be the case with other series, he noted.

Dr. Ujiki left the audience with two bits of advice to hasten the learning curve: leave at least 5 cm of overlap because the mesh will shrink down and keep the stitches close to the mesh without cutting off the bowel.

pwendling@frontlinemedcom.com

CHICAGO – Patients who underwent modified laparoscopic Sugarbaker parastomal hernia repair were a third less likely to experience recurrence as those repaired with other surgical techniques in a multicenter, retrospective study in 62 patients.

The recurrence rate was 16.6% for the modified Sugarbaker technique, compared with 61% for keyhole repair, 69.2% for ostomy relocation, and 33.3% for open repair (P value < .001). Median follow-up was 16.6 months, 19.6 months, 16.4 months, and 27.2 months (P = .748).

In an adjusted Cox proportional hazards regression model, the Sugarbaker technique (hazard ratio, 0.28; P = .021) and body mass index (HR, 1.09; P = .013) were the only significant predictors of time to hernia recurrence.

Using the Kaplan-Meier method, 80% of Sugarbaker patients would be recurrence free at 2 years vs. about 60% of those in the other groups (log-rank P = .021), Mr. Francis DeAsis, a research assistant from NorthShore University Health in Evanston, Ill., reported at the annual meeting of the Central Surgical Association.

The findings are in keeping with prior Sugarbaker studies involving 177 repairs between 2005 and 2013, reporting recurrence rates between 4% and 20% and morbidity of 12%-43%, he said.

Morbidity was 40% among the 25 Sugarbaker repairs in the current analysis, significantly lower than that in the Keyhole, relocation, and open repair groups (40% vs. 83.3%, 61.5%, 83.3%; P = .005).

“Based on our results and others, we’d like to suggest that the Sugarbaker approach should be the primary option for treating parastomal hernia,” Mr. DeAsis said.

The study provides “further proof that no other technique available results in a durable repair compared to the Sugarbaker technique for these challenging hernias,” senior study author Dr. Michael Ujiki, director of minimally invasive surgery at NorthShore, said in an interview.

The Sugarbaker technique typically involves a laparoscopic mesh sublay over the fascial defect and lateralization of the stoma limb. Modifications at NorthShore included use of polytetrafluoroethylene mesh with a 5-cm overlap of the defect and, if possible, primary closure of the defect. A catheter is occasionally used to identify the correct ostomy limb, but most importantly, a laparoscopic approach is utilized in order to decrease wound infections and quicken the return to daily activities, Dr. Ujiki said. “We also avoid cautery and diligently look for other incidental hernias at the prevision incisions.”

Ileus (> 3 days) was the most common complication in all groups: Sugarbaker (4/25), keyhole (9/18), relocation (3/13), and open (1/6). Only one death occurred; in the open group.

Discussant Dr. Matthew Goldblatt, with the Medical College of Wisconsin in Milwaukee, questioned how many patients also had ventral hernias and whether this was a complicating factor in ileus or length of stay and whether the fascia was closed primarily during keyhole repair or the mesh simply placed as a bridge, as this can impact failure rates.

Dr. Ujiki responded that some patients had concomitant ventral hernias and that they simply used a larger piece of mesh to cover both hernias. Primary closure was not part of the keyhole repair early in the 10-year series, spanning 2004 to 2014, but ultimately was performed in about half of patients in the keyhole group.

“I don’t think that there’s going to be a difference between the two in terms of recurrence, but I can’t say for sure,” he added.

At this point, the group does not use prophylactic mesh placement at the time the ostomy is created, to avoid infections.

Finally, the audience asked whether the investigators are willing to accept a 16% recurrence rate, a fourfold increase over the best reported result with a modified Sugarbaker technique.

“With these hernia repairs, to me a 16% recurrence rate is outstanding and I think it will only get better,” Dr. Ujiki said.

The series includes every patient on which they’ve performed a Sugarbaker and thus, represents their learning curve, which may not be the case with other series, he noted.

Dr. Ujiki left the audience with two bits of advice to hasten the learning curve: leave at least 5 cm of overlap because the mesh will shrink down and keep the stitches close to the mesh without cutting off the bowel.

pwendling@frontlinemedcom.com

CHICAGO – Patients who underwent modified laparoscopic Sugarbaker parastomal hernia repair were a third less likely to experience recurrence as those repaired with other surgical techniques in a multicenter, retrospective study in 62 patients.

The recurrence rate was 16.6% for the modified Sugarbaker technique, compared with 61% for keyhole repair, 69.2% for ostomy relocation, and 33.3% for open repair (P value < .001). Median follow-up was 16.6 months, 19.6 months, 16.4 months, and 27.2 months (P = .748).

In an adjusted Cox proportional hazards regression model, the Sugarbaker technique (hazard ratio, 0.28; P = .021) and body mass index (HR, 1.09; P = .013) were the only significant predictors of time to hernia recurrence.

Using the Kaplan-Meier method, 80% of Sugarbaker patients would be recurrence free at 2 years vs. about 60% of those in the other groups (log-rank P = .021), Mr. Francis DeAsis, a research assistant from NorthShore University Health in Evanston, Ill., reported at the annual meeting of the Central Surgical Association.

The findings are in keeping with prior Sugarbaker studies involving 177 repairs between 2005 and 2013, reporting recurrence rates between 4% and 20% and morbidity of 12%-43%, he said.

Morbidity was 40% among the 25 Sugarbaker repairs in the current analysis, significantly lower than that in the Keyhole, relocation, and open repair groups (40% vs. 83.3%, 61.5%, 83.3%; P = .005).

“Based on our results and others, we’d like to suggest that the Sugarbaker approach should be the primary option for treating parastomal hernia,” Mr. DeAsis said.

The study provides “further proof that no other technique available results in a durable repair compared to the Sugarbaker technique for these challenging hernias,” senior study author Dr. Michael Ujiki, director of minimally invasive surgery at NorthShore, said in an interview.

The Sugarbaker technique typically involves a laparoscopic mesh sublay over the fascial defect and lateralization of the stoma limb. Modifications at NorthShore included use of polytetrafluoroethylene mesh with a 5-cm overlap of the defect and, if possible, primary closure of the defect. A catheter is occasionally used to identify the correct ostomy limb, but most importantly, a laparoscopic approach is utilized in order to decrease wound infections and quicken the return to daily activities, Dr. Ujiki said. “We also avoid cautery and diligently look for other incidental hernias at the prevision incisions.”

Ileus (> 3 days) was the most common complication in all groups: Sugarbaker (4/25), keyhole (9/18), relocation (3/13), and open (1/6). Only one death occurred; in the open group.

Discussant Dr. Matthew Goldblatt, with the Medical College of Wisconsin in Milwaukee, questioned how many patients also had ventral hernias and whether this was a complicating factor in ileus or length of stay and whether the fascia was closed primarily during keyhole repair or the mesh simply placed as a bridge, as this can impact failure rates.

Dr. Ujiki responded that some patients had concomitant ventral hernias and that they simply used a larger piece of mesh to cover both hernias. Primary closure was not part of the keyhole repair early in the 10-year series, spanning 2004 to 2014, but ultimately was performed in about half of patients in the keyhole group.

“I don’t think that there’s going to be a difference between the two in terms of recurrence, but I can’t say for sure,” he added.

At this point, the group does not use prophylactic mesh placement at the time the ostomy is created, to avoid infections.

Finally, the audience asked whether the investigators are willing to accept a 16% recurrence rate, a fourfold increase over the best reported result with a modified Sugarbaker technique.

“With these hernia repairs, to me a 16% recurrence rate is outstanding and I think it will only get better,” Dr. Ujiki said.

The series includes every patient on which they’ve performed a Sugarbaker and thus, represents their learning curve, which may not be the case with other series, he noted.

Dr. Ujiki left the audience with two bits of advice to hasten the learning curve: leave at least 5 cm of overlap because the mesh will shrink down and keep the stitches close to the mesh without cutting off the bowel.

pwendling@frontlinemedcom.com

During 5 years of follow-up, cancer arose in only 0.3% of thyroid nodules that were cytologically and sonographically benign at baseline, according to a large prospective study published online March 3 in JAMA.

Furthermore, only two of the five nodules that became cancerous had grown beforehand, reported Dr. Cosimo Durante of the Sapienza University of Rome and his associates. “These data suggest that the American Thyroid Association’s recommendation for indication for repeat cytology should be revised. Clinical and sonographic findings should probably play larger roles in the decision-making process,” the researchers said (JAMA 2015;313:926-35).

©Sebastian Kaulitzki/Fotolia.com

Advances in diagnostic imaging have increased the detection of thyroid nodules, the great majority of which are found to be benign. For such nodules, the ATA recommends repeating thyroid ultrasonography at 6-18 months and then every 3-5 years thereafter, as long as nodules do not significantly grow (defined as at least a 20% increase in two nodule diameters, with a minimum increase of at least 2 mm [Thyroid 2009;19:1167-214]). But little is known about rate, extent, or predictors of nodule growth, the researchers noted. Therefore, they performed annual thyroid ultrasound examinations on 992 patients who had one to four asymptomatic subcentimeter thyroid modules that were cytologically or sonographically benign at baseline.

After 5 years of follow-up, just 15.4% of patients had experienced significant nodule growth according to the ATA definition, the researchers reported. Average growth was 4.9 mm, and 9.3% of patients developed new nodules, of which one was found to be cancerous. Growth was least likely when a patient’s largest nodule measured 7.5 mm or less and was significantly more likely when patients had multiple nodules instead of one; had baseline nodule volume greater than 0.2 mL; were up to 45 years old, compared with at least 60 years of age; and were male, the investigators said.

Among older patients, having a body mass index of 28.6 kg/m² more than doubled the odds of nodule growth, in keeping with recent reports linking obesity and insulin resistance with nodular thyroid disease, they added.

The findings suggest that repeat thyroid ultrasonography could be safely extended to 12 months for initial follow-up and to every 5 years thereafter for most patients, as long as nodule size remained stable, Dr. Durante and his associates said. “This approach should be suitable for about 85% of patients, whose risk of disease progression is low. Closer surveillance may be appropriate for nodules occurring in younger patients or older overweight individuals with multiple nodules, large nodules (greater than 7.5 mm), or both,” they added.

The Umberto Di Mario Foundation, Banca d’Italia, and the Italian Thyroid Cancer Observatory Foundation funded the study. The authors reported having no conflicts of interest.

During 5 years of follow-up, cancer arose in only 0.3% of thyroid nodules that were cytologically and sonographically benign at baseline, according to a large prospective study published online March 3 in JAMA.

Furthermore, only two of the five nodules that became cancerous had grown beforehand, reported Dr. Cosimo Durante of the Sapienza University of Rome and his associates. “These data suggest that the American Thyroid Association’s recommendation for indication for repeat cytology should be revised. Clinical and sonographic findings should probably play larger roles in the decision-making process,” the researchers said (JAMA 2015;313:926-35).

©Sebastian Kaulitzki/Fotolia.com

Advances in diagnostic imaging have increased the detection of thyroid nodules, the great majority of which are found to be benign. For such nodules, the ATA recommends repeating thyroid ultrasonography at 6-18 months and then every 3-5 years thereafter, as long as nodules do not significantly grow (defined as at least a 20% increase in two nodule diameters, with a minimum increase of at least 2 mm [Thyroid 2009;19:1167-214]). But little is known about rate, extent, or predictors of nodule growth, the researchers noted. Therefore, they performed annual thyroid ultrasound examinations on 992 patients who had one to four asymptomatic subcentimeter thyroid modules that were cytologically or sonographically benign at baseline.

After 5 years of follow-up, just 15.4% of patients had experienced significant nodule growth according to the ATA definition, the researchers reported. Average growth was 4.9 mm, and 9.3% of patients developed new nodules, of which one was found to be cancerous. Growth was least likely when a patient’s largest nodule measured 7.5 mm or less and was significantly more likely when patients had multiple nodules instead of one; had baseline nodule volume greater than 0.2 mL; were up to 45 years old, compared with at least 60 years of age; and were male, the investigators said.

Among older patients, having a body mass index of 28.6 kg/m² more than doubled the odds of nodule growth, in keeping with recent reports linking obesity and insulin resistance with nodular thyroid disease, they added.

The findings suggest that repeat thyroid ultrasonography could be safely extended to 12 months for initial follow-up and to every 5 years thereafter for most patients, as long as nodule size remained stable, Dr. Durante and his associates said. “This approach should be suitable for about 85% of patients, whose risk of disease progression is low. Closer surveillance may be appropriate for nodules occurring in younger patients or older overweight individuals with multiple nodules, large nodules (greater than 7.5 mm), or both,” they added.

The Umberto Di Mario Foundation, Banca d’Italia, and the Italian Thyroid Cancer Observatory Foundation funded the study. The authors reported having no conflicts of interest.

During 5 years of follow-up, cancer arose in only 0.3% of thyroid nodules that were cytologically and sonographically benign at baseline, according to a large prospective study published online March 3 in JAMA.

Furthermore, only two of the five nodules that became cancerous had grown beforehand, reported Dr. Cosimo Durante of the Sapienza University of Rome and his associates. “These data suggest that the American Thyroid Association’s recommendation for indication for repeat cytology should be revised. Clinical and sonographic findings should probably play larger roles in the decision-making process,” the researchers said (JAMA 2015;313:926-35).

©Sebastian Kaulitzki/Fotolia.com

Advances in diagnostic imaging have increased the detection of thyroid nodules, the great majority of which are found to be benign. For such nodules, the ATA recommends repeating thyroid ultrasonography at 6-18 months and then every 3-5 years thereafter, as long as nodules do not significantly grow (defined as at least a 20% increase in two nodule diameters, with a minimum increase of at least 2 mm [Thyroid 2009;19:1167-214]). But little is known about rate, extent, or predictors of nodule growth, the researchers noted. Therefore, they performed annual thyroid ultrasound examinations on 992 patients who had one to four asymptomatic subcentimeter thyroid modules that were cytologically or sonographically benign at baseline.

After 5 years of follow-up, just 15.4% of patients had experienced significant nodule growth according to the ATA definition, the researchers reported. Average growth was 4.9 mm, and 9.3% of patients developed new nodules, of which one was found to be cancerous. Growth was least likely when a patient’s largest nodule measured 7.5 mm or less and was significantly more likely when patients had multiple nodules instead of one; had baseline nodule volume greater than 0.2 mL; were up to 45 years old, compared with at least 60 years of age; and were male, the investigators said.

Among older patients, having a body mass index of 28.6 kg/m² more than doubled the odds of nodule growth, in keeping with recent reports linking obesity and insulin resistance with nodular thyroid disease, they added.

The findings suggest that repeat thyroid ultrasonography could be safely extended to 12 months for initial follow-up and to every 5 years thereafter for most patients, as long as nodule size remained stable, Dr. Durante and his associates said. “This approach should be suitable for about 85% of patients, whose risk of disease progression is low. Closer surveillance may be appropriate for nodules occurring in younger patients or older overweight individuals with multiple nodules, large nodules (greater than 7.5 mm), or both,” they added.

The Umberto Di Mario Foundation, Banca d’Italia, and the Italian Thyroid Cancer Observatory Foundation funded the study. The authors reported having no conflicts of interest.

Hospitals should carefully monitor equipment for hepatitis C virus contamination and the possibility of health care transmission, according to a Feb. 27 report from the Centers for Disease Control and Prevention.

Jezperklauzen/ThinkStock.com

The CDC report focuses on two specific cases of health care–transmitted HCV. In 2010, a patient without HCV in a New Jersey hospital was treated by an anesthesiologist who had immediately beforehand treated someone with HCV. Despite the single commonality between the two patients, patient A contracted HCV.

In 2011, a patient in Wisconsin with a history of diabetes and chronic renal disease was diagnosed with HCV-4, a subtype of the disease that is rare in that part of the world. The infection occurred in 2009, when this patient had a kidney transplant at the same time as a patient with HCV-4 also was having a kidney transplant. The two transplants shared a surgeon, but the source of infection was likely a perfusion machine where an HCV-positive kidney and an HCV-negative kidney were both stored without cleaning the machine.

“These cases illustrate the importance of partnerships and communication between public health and health care professionals to ensure that basic infection control and injection safety practices are optimized wherever health care is delivered,” the CDC investigators concluded.

Read the full report in the MMWR (2015;64:165-70).

Hospitals should carefully monitor equipment for hepatitis C virus contamination and the possibility of health care transmission, according to a Feb. 27 report from the Centers for Disease Control and Prevention.

Jezperklauzen/ThinkStock.com

The CDC report focuses on two specific cases of health care–transmitted HCV. In 2010, a patient without HCV in a New Jersey hospital was treated by an anesthesiologist who had immediately beforehand treated someone with HCV. Despite the single commonality between the two patients, patient A contracted HCV.

In 2011, a patient in Wisconsin with a history of diabetes and chronic renal disease was diagnosed with HCV-4, a subtype of the disease that is rare in that part of the world. The infection occurred in 2009, when this patient had a kidney transplant at the same time as a patient with HCV-4 also was having a kidney transplant. The two transplants shared a surgeon, but the source of infection was likely a perfusion machine where an HCV-positive kidney and an HCV-negative kidney were both stored without cleaning the machine.

“These cases illustrate the importance of partnerships and communication between public health and health care professionals to ensure that basic infection control and injection safety practices are optimized wherever health care is delivered,” the CDC investigators concluded.

Read the full report in the MMWR (2015;64:165-70).

Hospitals should carefully monitor equipment for hepatitis C virus contamination and the possibility of health care transmission, according to a Feb. 27 report from the Centers for Disease Control and Prevention.

Jezperklauzen/ThinkStock.com

The CDC report focuses on two specific cases of health care–transmitted HCV. In 2010, a patient without HCV in a New Jersey hospital was treated by an anesthesiologist who had immediately beforehand treated someone with HCV. Despite the single commonality between the two patients, patient A contracted HCV.

In 2011, a patient in Wisconsin with a history of diabetes and chronic renal disease was diagnosed with HCV-4, a subtype of the disease that is rare in that part of the world. The infection occurred in 2009, when this patient had a kidney transplant at the same time as a patient with HCV-4 also was having a kidney transplant. The two transplants shared a surgeon, but the source of infection was likely a perfusion machine where an HCV-positive kidney and an HCV-negative kidney were both stored without cleaning the machine.

“These cases illustrate the importance of partnerships and communication between public health and health care professionals to ensure that basic infection control and injection safety practices are optimized wherever health care is delivered,” the CDC investigators concluded.

Read the full report in the MMWR (2015;64:165-70).

The Food and Drug Administration has approved the antibacterial drug ceftazidime-avibactam (Avycaz) on Feb. 25 for complicated intra-abdominal infections in combination with metronidazole, and for complicated urinary tract infections including pyelonephritis in adults.

“It is important that the use of Avycaz be reserved for situations where there are limited or no alternative antibacterial drugs for treating a patient’s infection,” Dr. Edward Cox, director of the FDA’s Office of Antimicrobial Products in the Center for Drug Evaluation and Research, said in a statement.

Avycaz is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin with in vitro activity against certain gram-negative and gram-positive bacteria, and avibactam, a beta-lactamase inhibitor.

The addition of avibactam to ceftazidime protects ceftazidime from breakdown by extended spectrum beta-lactamases, Klebsiella pneumoniae carbapenemase (KPC), and AmpC-producing pathogens, according to David Nicholson, Ph.D., executive vice president of branded research and development at Actavis, which is jointly developing the drug with AstraZeneca.

“The FDA approval of Avycaz is an important step forward in enhancing our ability to respond to serious pathogens caused by difficult-to-treat gram-negative pathogens,” he said in a statement.

The recent rise in the incidence of multidrug-resistant gram-negative pathogens poses a significant threat to patients and places a tremendous strain on the U.S. health care system, Dr. Jose Vazquez, chief of infectious disease at Georgia Regents University in Augusta, Ga., commented in the same statement.

“The increasing prevalence of KPC-producing Enterobacteriaceae in particular, has become a major therapeutic challenge for physicians managing these infections. Unfortunately, there are currently a limited number of safe and effective antimicrobials to treat these serious infections,” he said.

Avycaz was granted priority review and named a Qualified Infectious Disease Product (QIDP), a designation given to antibacterial products to treat serious or life-threatening infections.

Its efficacy was supported in part by findings of the efficacy and safety of ceftazidime for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI). The contribution of avibactam to Avycaz was based on data from in vitro studies and animal models of infection. Avycaz was also studied in two phase II trials, one each in cIAI and cUTI.

The most common side effects are vomiting, nausea, constipation, and anxiety. The FDA advises health care professionals to inform patients of these risks and that decreased efficacy, seizures, and other neurologic events were seen in patients with renal impairment. Serious skin reactions and anaphylaxis may occur in patients with penicillin allergies.

The recommended dosage for patients with normal renal function is 2.5 g administered every 8 hours by intravenous infusion over 2 hours in adults aged 18 years and older. For patients with changing or impaired renal function (creatinine clearance < 50 mL/min), CrCL should be monitored at least daily and the dosage adjusted accordingly.

In a phase III trial of intra-abdominal infections, clinical cure rates were lower in the subgroup of patients with CrCL of 30-50 mL/min, compared with those with CrCL greater than 50 mL/min, according to the company. The reduction in cure rates was more marked in patients treated with Avycaz plus metronidazole vs. meropenem-treated patients.

Avycaz will be available in the second quarter of 2015, according to the company. Phase III studies evaluating Avycaz for the treatment of cIAI and cUTI are ongoing and targeted for completion in late 2015.

pwendling@frontlinemedcom.com

The Food and Drug Administration has approved the antibacterial drug ceftazidime-avibactam (Avycaz) on Feb. 25 for complicated intra-abdominal infections in combination with metronidazole, and for complicated urinary tract infections including pyelonephritis in adults.

“It is important that the use of Avycaz be reserved for situations where there are limited or no alternative antibacterial drugs for treating a patient’s infection,” Dr. Edward Cox, director of the FDA’s Office of Antimicrobial Products in the Center for Drug Evaluation and Research, said in a statement.

Avycaz is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin with in vitro activity against certain gram-negative and gram-positive bacteria, and avibactam, a beta-lactamase inhibitor.

The addition of avibactam to ceftazidime protects ceftazidime from breakdown by extended spectrum beta-lactamases, Klebsiella pneumoniae carbapenemase (KPC), and AmpC-producing pathogens, according to David Nicholson, Ph.D., executive vice president of branded research and development at Actavis, which is jointly developing the drug with AstraZeneca.

“The FDA approval of Avycaz is an important step forward in enhancing our ability to respond to serious pathogens caused by difficult-to-treat gram-negative pathogens,” he said in a statement.

The recent rise in the incidence of multidrug-resistant gram-negative pathogens poses a significant threat to patients and places a tremendous strain on the U.S. health care system, Dr. Jose Vazquez, chief of infectious disease at Georgia Regents University in Augusta, Ga., commented in the same statement.

“The increasing prevalence of KPC-producing Enterobacteriaceae in particular, has become a major therapeutic challenge for physicians managing these infections. Unfortunately, there are currently a limited number of safe and effective antimicrobials to treat these serious infections,” he said.

Avycaz was granted priority review and named a Qualified Infectious Disease Product (QIDP), a designation given to antibacterial products to treat serious or life-threatening infections.

Its efficacy was supported in part by findings of the efficacy and safety of ceftazidime for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI). The contribution of avibactam to Avycaz was based on data from in vitro studies and animal models of infection. Avycaz was also studied in two phase II trials, one each in cIAI and cUTI.

The most common side effects are vomiting, nausea, constipation, and anxiety. The FDA advises health care professionals to inform patients of these risks and that decreased efficacy, seizures, and other neurologic events were seen in patients with renal impairment. Serious skin reactions and anaphylaxis may occur in patients with penicillin allergies.

The recommended dosage for patients with normal renal function is 2.5 g administered every 8 hours by intravenous infusion over 2 hours in adults aged 18 years and older. For patients with changing or impaired renal function (creatinine clearance < 50 mL/min), CrCL should be monitored at least daily and the dosage adjusted accordingly.

In a phase III trial of intra-abdominal infections, clinical cure rates were lower in the subgroup of patients with CrCL of 30-50 mL/min, compared with those with CrCL greater than 50 mL/min, according to the company. The reduction in cure rates was more marked in patients treated with Avycaz plus metronidazole vs. meropenem-treated patients.

Avycaz will be available in the second quarter of 2015, according to the company. Phase III studies evaluating Avycaz for the treatment of cIAI and cUTI are ongoing and targeted for completion in late 2015.

pwendling@frontlinemedcom.com

The Food and Drug Administration has approved the antibacterial drug ceftazidime-avibactam (Avycaz) on Feb. 25 for complicated intra-abdominal infections in combination with metronidazole, and for complicated urinary tract infections including pyelonephritis in adults.

“It is important that the use of Avycaz be reserved for situations where there are limited or no alternative antibacterial drugs for treating a patient’s infection,” Dr. Edward Cox, director of the FDA’s Office of Antimicrobial Products in the Center for Drug Evaluation and Research, said in a statement.

Avycaz is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin with in vitro activity against certain gram-negative and gram-positive bacteria, and avibactam, a beta-lactamase inhibitor.

The addition of avibactam to ceftazidime protects ceftazidime from breakdown by extended spectrum beta-lactamases, Klebsiella pneumoniae carbapenemase (KPC), and AmpC-producing pathogens, according to David Nicholson, Ph.D., executive vice president of branded research and development at Actavis, which is jointly developing the drug with AstraZeneca.

“The FDA approval of Avycaz is an important step forward in enhancing our ability to respond to serious pathogens caused by difficult-to-treat gram-negative pathogens,” he said in a statement.

The recent rise in the incidence of multidrug-resistant gram-negative pathogens poses a significant threat to patients and places a tremendous strain on the U.S. health care system, Dr. Jose Vazquez, chief of infectious disease at Georgia Regents University in Augusta, Ga., commented in the same statement.

“The increasing prevalence of KPC-producing Enterobacteriaceae in particular, has become a major therapeutic challenge for physicians managing these infections. Unfortunately, there are currently a limited number of safe and effective antimicrobials to treat these serious infections,” he said.

Avycaz was granted priority review and named a Qualified Infectious Disease Product (QIDP), a designation given to antibacterial products to treat serious or life-threatening infections.

Its efficacy was supported in part by findings of the efficacy and safety of ceftazidime for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI). The contribution of avibactam to Avycaz was based on data from in vitro studies and animal models of infection. Avycaz was also studied in two phase II trials, one each in cIAI and cUTI.

The most common side effects are vomiting, nausea, constipation, and anxiety. The FDA advises health care professionals to inform patients of these risks and that decreased efficacy, seizures, and other neurologic events were seen in patients with renal impairment. Serious skin reactions and anaphylaxis may occur in patients with penicillin allergies.

The recommended dosage for patients with normal renal function is 2.5 g administered every 8 hours by intravenous infusion over 2 hours in adults aged 18 years and older. For patients with changing or impaired renal function (creatinine clearance < 50 mL/min), CrCL should be monitored at least daily and the dosage adjusted accordingly.

In a phase III trial of intra-abdominal infections, clinical cure rates were lower in the subgroup of patients with CrCL of 30-50 mL/min, compared with those with CrCL greater than 50 mL/min, according to the company. The reduction in cure rates was more marked in patients treated with Avycaz plus metronidazole vs. meropenem-treated patients.

Avycaz will be available in the second quarter of 2015, according to the company. Phase III studies evaluating Avycaz for the treatment of cIAI and cUTI are ongoing and targeted for completion in late 2015.

pwendling@frontlinemedcom.com

The American College of Surgeons’ NSQIP surgical risk calculator was effective for evaluating patients at average surgical risk undergoing laparoscopic colectomy at a single institution, but did not accurately predict outcomes in a small percentage of patients when one or more serious complications occurred, a new study has found.

Specifically, the actual length of stay (LOS) was significantly longer than predicted by the calculator (4.22 days vs. 4.11 days; P = .0001), with four outliers with multiple complications having an LOS more than 3 standard deviations from the mean. After removing the outliers, the actual LOS was significantly shorter than that predicted (3.31 days vs. 4.05 days; P = .002). Occurrence of any complication was also significantly lower than predicted (17.3% vs. 19.4%; P = .05).

“Addition of surgeon- and patient-specific data via the American College of Surgeons case-logging system could better adjust for these areas,” study author Dr. Kyle Cologne and his colleagues recommend.

Read the full article at J. Am. Coll. Surg. 2015;220:281-6.

The American College of Surgeons’ NSQIP surgical risk calculator was effective for evaluating patients at average surgical risk undergoing laparoscopic colectomy at a single institution, but did not accurately predict outcomes in a small percentage of patients when one or more serious complications occurred, a new study has found.

Specifically, the actual length of stay (LOS) was significantly longer than predicted by the calculator (4.22 days vs. 4.11 days; P = .0001), with four outliers with multiple complications having an LOS more than 3 standard deviations from the mean. After removing the outliers, the actual LOS was significantly shorter than that predicted (3.31 days vs. 4.05 days; P = .002). Occurrence of any complication was also significantly lower than predicted (17.3% vs. 19.4%; P = .05).

“Addition of surgeon- and patient-specific data via the American College of Surgeons case-logging system could better adjust for these areas,” study author Dr. Kyle Cologne and his colleagues recommend.

Read the full article at J. Am. Coll. Surg. 2015;220:281-6.

The American College of Surgeons’ NSQIP surgical risk calculator was effective for evaluating patients at average surgical risk undergoing laparoscopic colectomy at a single institution, but did not accurately predict outcomes in a small percentage of patients when one or more serious complications occurred, a new study has found.

Specifically, the actual length of stay (LOS) was significantly longer than predicted by the calculator (4.22 days vs. 4.11 days; P = .0001), with four outliers with multiple complications having an LOS more than 3 standard deviations from the mean. After removing the outliers, the actual LOS was significantly shorter than that predicted (3.31 days vs. 4.05 days; P = .002). Occurrence of any complication was also significantly lower than predicted (17.3% vs. 19.4%; P = .05).

“Addition of surgeon- and patient-specific data via the American College of Surgeons case-logging system could better adjust for these areas,” study author Dr. Kyle Cologne and his colleagues recommend.

Read the full article at J. Am. Coll. Surg. 2015;220:281-6.