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Bile spillage during lap cholecystectomy comes with a price
Bile spillage that happens during laparoscopic gallbladder removal is a known problem, but a large study has put some numbers to quantify the risks to patients.
A research team at Massachusetts General Hospital, Boston, conducted a prospective study of 1,001 such operations to look at the impact of bile spillage. They found that wound infection rates in cases involving bile spillage were almost three times higher than were those without spillage and resulting hospital stays were 50% longer, according to an article in the Journal of the American College of Surgeons.
The study involved adults who had laparoscopic and laparoscopic converted to open cholecystectomy at the academic hospital during May 2010-March 2017. The latter category accounted for 95 patients, a 9.5% conversion rate. Overall, bile was spilled in 591 patients (59%), with empyema in 86 (8.6%), hydrops in 62 (6.2%), and clear bile spillage in the remainder. Bile spillage along with gallstone spillage occurred in 202 patients (20.2%), with recovery of all spilled gallstones in 145 (71.8%) of those cases.
Overall, the surgical site infection (SSI) rate was 2.4% (n = 8) in patients with no bile spillage vs. 7.1% (n = 30) for those with bile spillage. Median hospital length of stay was 2 days for the nonspillage patients vs. 3 days for those with spillage. The 30-day readmission rates were 5.9% for the nonspillage group vs. 9.6% for the spillage group.
The bile spillage rate in this study was considerably higher than previous studies had reported, the researchers noted. A retrospective study of 1,127 patients reported a spillage rate of 11.6% (World J Surg. 1999;23:1186-90). “One needs to notice that a retrospective review of medical records almost certainly underappreciates the rate of bile spillage,” the investigators wrote. A Mayo Clinic study reported a bile spillage rate of 29% and an increased risk of intra-abdominal abscesses (J Gastrointest Surg. 1997;1:85-90). The complex and acute nature of the cases at Mass General may explain their higher spillage rates, the researchers suggested.
This study identifies bile spillage, along with conversion to open surgery and patient ASA class 2 or higher as the only independent predictors of SSI. The study also found no link between empyema and hydrops with SSI, although the small number of cases may preclude an representative sample.
Nonetheless, surgeons must face the question of how to decrease SSI in laparoscopic cholecystectomy with bile spillage, study authors wrote. “First, surgeons should acknowledge that gallbladder perforations and bile spillage come at a price,” they said, “and thus should be cautious and try to avoid them.”
When bile is spilled, liberal peritoneal irrigation may be futile; this study showed similar SSI rates after bile spillage, regardless of peritoneal irrigation. “We could consider modifying perioperative antibiotic coverage,” the investigators wrote, but they acknowledged a need for more research to validate its benefit.
The investigators reported having no financial disclosures.
SOURCE: Peponis T et al. J Am Coll Surg. 2018 Mar 1. doi: 10.1016/j.jamcollsurg.2017.11.025.
Bile spillage that happens during laparoscopic gallbladder removal is a known problem, but a large study has put some numbers to quantify the risks to patients.
A research team at Massachusetts General Hospital, Boston, conducted a prospective study of 1,001 such operations to look at the impact of bile spillage. They found that wound infection rates in cases involving bile spillage were almost three times higher than were those without spillage and resulting hospital stays were 50% longer, according to an article in the Journal of the American College of Surgeons.
The study involved adults who had laparoscopic and laparoscopic converted to open cholecystectomy at the academic hospital during May 2010-March 2017. The latter category accounted for 95 patients, a 9.5% conversion rate. Overall, bile was spilled in 591 patients (59%), with empyema in 86 (8.6%), hydrops in 62 (6.2%), and clear bile spillage in the remainder. Bile spillage along with gallstone spillage occurred in 202 patients (20.2%), with recovery of all spilled gallstones in 145 (71.8%) of those cases.
Overall, the surgical site infection (SSI) rate was 2.4% (n = 8) in patients with no bile spillage vs. 7.1% (n = 30) for those with bile spillage. Median hospital length of stay was 2 days for the nonspillage patients vs. 3 days for those with spillage. The 30-day readmission rates were 5.9% for the nonspillage group vs. 9.6% for the spillage group.
The bile spillage rate in this study was considerably higher than previous studies had reported, the researchers noted. A retrospective study of 1,127 patients reported a spillage rate of 11.6% (World J Surg. 1999;23:1186-90). “One needs to notice that a retrospective review of medical records almost certainly underappreciates the rate of bile spillage,” the investigators wrote. A Mayo Clinic study reported a bile spillage rate of 29% and an increased risk of intra-abdominal abscesses (J Gastrointest Surg. 1997;1:85-90). The complex and acute nature of the cases at Mass General may explain their higher spillage rates, the researchers suggested.
This study identifies bile spillage, along with conversion to open surgery and patient ASA class 2 or higher as the only independent predictors of SSI. The study also found no link between empyema and hydrops with SSI, although the small number of cases may preclude an representative sample.
Nonetheless, surgeons must face the question of how to decrease SSI in laparoscopic cholecystectomy with bile spillage, study authors wrote. “First, surgeons should acknowledge that gallbladder perforations and bile spillage come at a price,” they said, “and thus should be cautious and try to avoid them.”
When bile is spilled, liberal peritoneal irrigation may be futile; this study showed similar SSI rates after bile spillage, regardless of peritoneal irrigation. “We could consider modifying perioperative antibiotic coverage,” the investigators wrote, but they acknowledged a need for more research to validate its benefit.
The investigators reported having no financial disclosures.
SOURCE: Peponis T et al. J Am Coll Surg. 2018 Mar 1. doi: 10.1016/j.jamcollsurg.2017.11.025.
Bile spillage that happens during laparoscopic gallbladder removal is a known problem, but a large study has put some numbers to quantify the risks to patients.
A research team at Massachusetts General Hospital, Boston, conducted a prospective study of 1,001 such operations to look at the impact of bile spillage. They found that wound infection rates in cases involving bile spillage were almost three times higher than were those without spillage and resulting hospital stays were 50% longer, according to an article in the Journal of the American College of Surgeons.
The study involved adults who had laparoscopic and laparoscopic converted to open cholecystectomy at the academic hospital during May 2010-March 2017. The latter category accounted for 95 patients, a 9.5% conversion rate. Overall, bile was spilled in 591 patients (59%), with empyema in 86 (8.6%), hydrops in 62 (6.2%), and clear bile spillage in the remainder. Bile spillage along with gallstone spillage occurred in 202 patients (20.2%), with recovery of all spilled gallstones in 145 (71.8%) of those cases.
Overall, the surgical site infection (SSI) rate was 2.4% (n = 8) in patients with no bile spillage vs. 7.1% (n = 30) for those with bile spillage. Median hospital length of stay was 2 days for the nonspillage patients vs. 3 days for those with spillage. The 30-day readmission rates were 5.9% for the nonspillage group vs. 9.6% for the spillage group.
The bile spillage rate in this study was considerably higher than previous studies had reported, the researchers noted. A retrospective study of 1,127 patients reported a spillage rate of 11.6% (World J Surg. 1999;23:1186-90). “One needs to notice that a retrospective review of medical records almost certainly underappreciates the rate of bile spillage,” the investigators wrote. A Mayo Clinic study reported a bile spillage rate of 29% and an increased risk of intra-abdominal abscesses (J Gastrointest Surg. 1997;1:85-90). The complex and acute nature of the cases at Mass General may explain their higher spillage rates, the researchers suggested.
This study identifies bile spillage, along with conversion to open surgery and patient ASA class 2 or higher as the only independent predictors of SSI. The study also found no link between empyema and hydrops with SSI, although the small number of cases may preclude an representative sample.
Nonetheless, surgeons must face the question of how to decrease SSI in laparoscopic cholecystectomy with bile spillage, study authors wrote. “First, surgeons should acknowledge that gallbladder perforations and bile spillage come at a price,” they said, “and thus should be cautious and try to avoid them.”
When bile is spilled, liberal peritoneal irrigation may be futile; this study showed similar SSI rates after bile spillage, regardless of peritoneal irrigation. “We could consider modifying perioperative antibiotic coverage,” the investigators wrote, but they acknowledged a need for more research to validate its benefit.
The investigators reported having no financial disclosures.
SOURCE: Peponis T et al. J Am Coll Surg. 2018 Mar 1. doi: 10.1016/j.jamcollsurg.2017.11.025.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF SURGEONS
Key clinical point: Bile spillage during laparoscopic cholecystectomy increases the patient’s risk for surgical site infection.
Major finding: Surgical site infection rates were 7.1% in cases in which bile spillage occurred vs. 2.4% in cases that had no bile spillage.
Data source: Prospective analysis of 1,001 laparoscopic or laparoscopic converted to open operations in adults during May 2010-March 2017.
Disclosures: Dr. Velmahos and coauthors reported having no financial disclosures.
Source: Peponis T et al. J Am Coll Surg. 2018 Mar 1. doi: 10.1016/j.jamcollsurg.2017.11.025.
Minimally invasive colon surgery: Managing conversions
LAS VEGAS – Minimally invasive colon surgery has many advantages over an open procedure with respect to complications and patient recovery, but as surgeons are well aware, sometimes conversion cannot and should not be avoided. “It’s going to happen, and if you’re not converting any of your patients, then you’re probably not being aggressive enough,” said Bradley R. Davis, MD, FACS, at a talk he gave on the topic at the Annual Minimally Invasive Surgery Symposium (MISS) 2018 by Global Academy for Medical Education.
Dr. Davis discussed some of the most common reasons for conversion to open surgery and strategies to try to reduce the incidence. He is the chief of general surgery and the chief of rectal and rectal surgery at Carolinas Medical Center, Charlotte, N.C.
A 2017 survey of 41,417 left hemicolectomy and sigmoidectomy procedures revealed that 63.4% were attempted laparoscopically, and the rate of conversion to an open procedure was 13.4% (JSLS. 2017 Jul-Sep;21[3]:e2017.00036). “I think that if your conversation rate is between 5% and 15%, [it’s] perfectly acceptable,” said Dr. Davis.
He suggested that surgeons should be willing to consider an increasing number of cases for minimally invasive surgery, despite the risk of conversion. By taking some precautions and being aware of which cases are most likely to lead to conversion, surgeons can potentially reduce the conversion rate – or at least lessen the effects it can have on patients and on costs.
Dr. Davis started with a discussion of the surgeon factors that can affect conversion rates. Medial and lateral approaches seem to have similar learning curves. “You’ve got to just stick to one approach. There’s not going to be any difference in terms of [frequency of] conversions,” said Dr. Davis.
Vascular pedicle ligation is the easiest approach, he said. Flexure mobilizations can be challenging, but they aren’t necessarily easier in open surgery. “If you’re struggling to mobilize the flexure, that may be the time to keep struggling because often when we go to open surgery [it doesn’t] get any easier,” said Dr. Davis.
The transverse colon mesentery is most difficult. “If you’re early in your learning curve, that’s something that’s going to be a little more difficult. The learning curve is between 50 and 60 cases,” said Dr. Davis.
Adhesions are the most common cause of conversions, but Dr. Davis said he generally starts with an attempt at laparoscopy. When he has a questionable case, he notifies the operating room staff that it should be prepared for a conversion so they don’t open a lot of disposables.
Other causes of conversion include pedicle or solid organ bleeding, hollow viscus injuries, and anastomotic complications. “As you get more up on your learning curve, you’ll be more comfortable in managing a hole in the bowel laparoscopically. ... Often you can manage those through your extraction site, so you can temporize that with a stitch and then bring it out and look at it,” said Dr. Davis.
Air leaks while doing an anastomosis on the sigmoid can also lead to conversion. “If you have a Pfannenstiel incision, you can do it through the Pfannenstiel, but if you have no incision, you are probably going to want to do some kind of incision to take a peek at that,” said Dr. Davis.
In neoplasms, conversions are common to ensure negative margins, which can’t always be accomplished laparoscopically.
Severe diverticulitis is another case that can mean a conversion, but hand-assisted techniques can be employed to avoid conversion. In severe diverticulitis, ureteral catheters can be helpful. “We identified a lower incidence of ureteral injury [with the use of ureteral catheters] in diverticulitis and T4 cancers. If you have a big phlegmon or a big cancer, I would definitely consider ureteral catheters,” said Dr. Davis. He pointed out that an inability to pinpoint the ureter is daunting in these types of cases. “That’s another thing to plan on if you know you’re going into these tough cases – trying to maximize your chances of not having a conversion by giving yourself the best possible tools to and the best visualization possible,” he added.
Obesity and inflammatory bowel disease are other conversion risk factors, as is performing a left hemicolectomy versus a sigmoidectomy. “As you plan your surgery, if you know you’ve got an obese patient with bad diverticulitis, this might be someone you would schedule as a laparoscopic versus open, with minimum disposable equipment in the room, knowing that, if it’s just not going to happen, then you need to open,” said Dr. Davis.
Technical factors that can contribute to conversion include failures of staplers, clips, and energy devices. When bleeding occurs as a result of an energy device, he doesn’t repeat its use. “If the energy has failed, I go right to an endoloop,” said Dr. Davis.
Bleeding in general needs to be controlled quickly or converted to open. “If you can’t get control of bleeding, that’s when you want to make a quick decision to open. You don’t want to lose two liters of blood trying to be fancy,” said Dr. Davis.
“Cautery injuries will happen, and it doesn’t take much to cause a full-thickness injury. It’s important to address it immediately, rather than move on, since it can be difficult to find after you’ve moved on to something else. Serosal injuries should also be dealt with right away,” he said.
A staple misfire can sometimes be repaired laparoscopically, but if it can’t, the patient should be opened up. “It’s just not worth the leak to prevent an incision,” said Dr. Davis.
Finally, body mass index is a strong predictor of conversion because of the difficulties it presents. “These aren’t cases that are fun to do open, either, but it’s going to be something that we’ll have to get better and better at as we see more of these patients,” said Dr. Davis.
Global Academy for Medical Education and this news organization are owned by the same parent company.
LAS VEGAS – Minimally invasive colon surgery has many advantages over an open procedure with respect to complications and patient recovery, but as surgeons are well aware, sometimes conversion cannot and should not be avoided. “It’s going to happen, and if you’re not converting any of your patients, then you’re probably not being aggressive enough,” said Bradley R. Davis, MD, FACS, at a talk he gave on the topic at the Annual Minimally Invasive Surgery Symposium (MISS) 2018 by Global Academy for Medical Education.
Dr. Davis discussed some of the most common reasons for conversion to open surgery and strategies to try to reduce the incidence. He is the chief of general surgery and the chief of rectal and rectal surgery at Carolinas Medical Center, Charlotte, N.C.
A 2017 survey of 41,417 left hemicolectomy and sigmoidectomy procedures revealed that 63.4% were attempted laparoscopically, and the rate of conversion to an open procedure was 13.4% (JSLS. 2017 Jul-Sep;21[3]:e2017.00036). “I think that if your conversation rate is between 5% and 15%, [it’s] perfectly acceptable,” said Dr. Davis.
He suggested that surgeons should be willing to consider an increasing number of cases for minimally invasive surgery, despite the risk of conversion. By taking some precautions and being aware of which cases are most likely to lead to conversion, surgeons can potentially reduce the conversion rate – or at least lessen the effects it can have on patients and on costs.
Dr. Davis started with a discussion of the surgeon factors that can affect conversion rates. Medial and lateral approaches seem to have similar learning curves. “You’ve got to just stick to one approach. There’s not going to be any difference in terms of [frequency of] conversions,” said Dr. Davis.
Vascular pedicle ligation is the easiest approach, he said. Flexure mobilizations can be challenging, but they aren’t necessarily easier in open surgery. “If you’re struggling to mobilize the flexure, that may be the time to keep struggling because often when we go to open surgery [it doesn’t] get any easier,” said Dr. Davis.
The transverse colon mesentery is most difficult. “If you’re early in your learning curve, that’s something that’s going to be a little more difficult. The learning curve is between 50 and 60 cases,” said Dr. Davis.
Adhesions are the most common cause of conversions, but Dr. Davis said he generally starts with an attempt at laparoscopy. When he has a questionable case, he notifies the operating room staff that it should be prepared for a conversion so they don’t open a lot of disposables.
Other causes of conversion include pedicle or solid organ bleeding, hollow viscus injuries, and anastomotic complications. “As you get more up on your learning curve, you’ll be more comfortable in managing a hole in the bowel laparoscopically. ... Often you can manage those through your extraction site, so you can temporize that with a stitch and then bring it out and look at it,” said Dr. Davis.
Air leaks while doing an anastomosis on the sigmoid can also lead to conversion. “If you have a Pfannenstiel incision, you can do it through the Pfannenstiel, but if you have no incision, you are probably going to want to do some kind of incision to take a peek at that,” said Dr. Davis.
In neoplasms, conversions are common to ensure negative margins, which can’t always be accomplished laparoscopically.
Severe diverticulitis is another case that can mean a conversion, but hand-assisted techniques can be employed to avoid conversion. In severe diverticulitis, ureteral catheters can be helpful. “We identified a lower incidence of ureteral injury [with the use of ureteral catheters] in diverticulitis and T4 cancers. If you have a big phlegmon or a big cancer, I would definitely consider ureteral catheters,” said Dr. Davis. He pointed out that an inability to pinpoint the ureter is daunting in these types of cases. “That’s another thing to plan on if you know you’re going into these tough cases – trying to maximize your chances of not having a conversion by giving yourself the best possible tools to and the best visualization possible,” he added.
Obesity and inflammatory bowel disease are other conversion risk factors, as is performing a left hemicolectomy versus a sigmoidectomy. “As you plan your surgery, if you know you’ve got an obese patient with bad diverticulitis, this might be someone you would schedule as a laparoscopic versus open, with minimum disposable equipment in the room, knowing that, if it’s just not going to happen, then you need to open,” said Dr. Davis.
Technical factors that can contribute to conversion include failures of staplers, clips, and energy devices. When bleeding occurs as a result of an energy device, he doesn’t repeat its use. “If the energy has failed, I go right to an endoloop,” said Dr. Davis.
Bleeding in general needs to be controlled quickly or converted to open. “If you can’t get control of bleeding, that’s when you want to make a quick decision to open. You don’t want to lose two liters of blood trying to be fancy,” said Dr. Davis.
“Cautery injuries will happen, and it doesn’t take much to cause a full-thickness injury. It’s important to address it immediately, rather than move on, since it can be difficult to find after you’ve moved on to something else. Serosal injuries should also be dealt with right away,” he said.
A staple misfire can sometimes be repaired laparoscopically, but if it can’t, the patient should be opened up. “It’s just not worth the leak to prevent an incision,” said Dr. Davis.
Finally, body mass index is a strong predictor of conversion because of the difficulties it presents. “These aren’t cases that are fun to do open, either, but it’s going to be something that we’ll have to get better and better at as we see more of these patients,” said Dr. Davis.
Global Academy for Medical Education and this news organization are owned by the same parent company.
LAS VEGAS – Minimally invasive colon surgery has many advantages over an open procedure with respect to complications and patient recovery, but as surgeons are well aware, sometimes conversion cannot and should not be avoided. “It’s going to happen, and if you’re not converting any of your patients, then you’re probably not being aggressive enough,” said Bradley R. Davis, MD, FACS, at a talk he gave on the topic at the Annual Minimally Invasive Surgery Symposium (MISS) 2018 by Global Academy for Medical Education.
Dr. Davis discussed some of the most common reasons for conversion to open surgery and strategies to try to reduce the incidence. He is the chief of general surgery and the chief of rectal and rectal surgery at Carolinas Medical Center, Charlotte, N.C.
A 2017 survey of 41,417 left hemicolectomy and sigmoidectomy procedures revealed that 63.4% were attempted laparoscopically, and the rate of conversion to an open procedure was 13.4% (JSLS. 2017 Jul-Sep;21[3]:e2017.00036). “I think that if your conversation rate is between 5% and 15%, [it’s] perfectly acceptable,” said Dr. Davis.
He suggested that surgeons should be willing to consider an increasing number of cases for minimally invasive surgery, despite the risk of conversion. By taking some precautions and being aware of which cases are most likely to lead to conversion, surgeons can potentially reduce the conversion rate – or at least lessen the effects it can have on patients and on costs.
Dr. Davis started with a discussion of the surgeon factors that can affect conversion rates. Medial and lateral approaches seem to have similar learning curves. “You’ve got to just stick to one approach. There’s not going to be any difference in terms of [frequency of] conversions,” said Dr. Davis.
Vascular pedicle ligation is the easiest approach, he said. Flexure mobilizations can be challenging, but they aren’t necessarily easier in open surgery. “If you’re struggling to mobilize the flexure, that may be the time to keep struggling because often when we go to open surgery [it doesn’t] get any easier,” said Dr. Davis.
The transverse colon mesentery is most difficult. “If you’re early in your learning curve, that’s something that’s going to be a little more difficult. The learning curve is between 50 and 60 cases,” said Dr. Davis.
Adhesions are the most common cause of conversions, but Dr. Davis said he generally starts with an attempt at laparoscopy. When he has a questionable case, he notifies the operating room staff that it should be prepared for a conversion so they don’t open a lot of disposables.
Other causes of conversion include pedicle or solid organ bleeding, hollow viscus injuries, and anastomotic complications. “As you get more up on your learning curve, you’ll be more comfortable in managing a hole in the bowel laparoscopically. ... Often you can manage those through your extraction site, so you can temporize that with a stitch and then bring it out and look at it,” said Dr. Davis.
Air leaks while doing an anastomosis on the sigmoid can also lead to conversion. “If you have a Pfannenstiel incision, you can do it through the Pfannenstiel, but if you have no incision, you are probably going to want to do some kind of incision to take a peek at that,” said Dr. Davis.
In neoplasms, conversions are common to ensure negative margins, which can’t always be accomplished laparoscopically.
Severe diverticulitis is another case that can mean a conversion, but hand-assisted techniques can be employed to avoid conversion. In severe diverticulitis, ureteral catheters can be helpful. “We identified a lower incidence of ureteral injury [with the use of ureteral catheters] in diverticulitis and T4 cancers. If you have a big phlegmon or a big cancer, I would definitely consider ureteral catheters,” said Dr. Davis. He pointed out that an inability to pinpoint the ureter is daunting in these types of cases. “That’s another thing to plan on if you know you’re going into these tough cases – trying to maximize your chances of not having a conversion by giving yourself the best possible tools to and the best visualization possible,” he added.
Obesity and inflammatory bowel disease are other conversion risk factors, as is performing a left hemicolectomy versus a sigmoidectomy. “As you plan your surgery, if you know you’ve got an obese patient with bad diverticulitis, this might be someone you would schedule as a laparoscopic versus open, with minimum disposable equipment in the room, knowing that, if it’s just not going to happen, then you need to open,” said Dr. Davis.
Technical factors that can contribute to conversion include failures of staplers, clips, and energy devices. When bleeding occurs as a result of an energy device, he doesn’t repeat its use. “If the energy has failed, I go right to an endoloop,” said Dr. Davis.
Bleeding in general needs to be controlled quickly or converted to open. “If you can’t get control of bleeding, that’s when you want to make a quick decision to open. You don’t want to lose two liters of blood trying to be fancy,” said Dr. Davis.
“Cautery injuries will happen, and it doesn’t take much to cause a full-thickness injury. It’s important to address it immediately, rather than move on, since it can be difficult to find after you’ve moved on to something else. Serosal injuries should also be dealt with right away,” he said.
A staple misfire can sometimes be repaired laparoscopically, but if it can’t, the patient should be opened up. “It’s just not worth the leak to prevent an incision,” said Dr. Davis.
Finally, body mass index is a strong predictor of conversion because of the difficulties it presents. “These aren’t cases that are fun to do open, either, but it’s going to be something that we’ll have to get better and better at as we see more of these patients,” said Dr. Davis.
Global Academy for Medical Education and this news organization are owned by the same parent company.
REPORTING FROM MISS
Easing into laparoscopic colectomy
LAS VEGAS – , including reduced hospital length of stay, less pain, faster return to work, and reduced incidence of adhesive small bowel obstructions. But the methods are underutilized, in part because they can be challenging to learn.
There are some tools and methods that can help surgeons perform surgeries laparoscopically, including hand-assisted laparoscopy and the use of single-incision laparoscopic colectomy (SILC). These methods were the subject of a talk at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.
Between 2009 and 2012, a little over 30% of colon cancer cases in the United States and about half of diverticulitis cases were performed laparoscopically. The percentage of laparoscopic procedures ticked up slightly from 2009 to 2012, but only by a few percentage points. “The fact is, we’re just not doing [minimally invasive procedures],” Ian M. Paquette, MD, FACS, associate professor of surgery at the University of Cincinnati, said during his talk.
When a laparoscopic procedure proves challenging, one option is the hand-assist technique. The literature hasn’t been very supportive of the method, with one study of data from the American College of Surgeons National Surgical Quality Improvement Program showing that it offers no improvement in operation time, compared with standard laparoscopy, and that it has slightly higher complication rates (J Gastrointest Surg. 2016 Nov;20[11]:1854-60). “They say you should do everything laparoscopically,” said Dr. Paquette.
One high-volume surgeon showed what happened over time when his practice employed hand-assisted laparoscopy for diverticulitis cases (Dis Colon Rectum. 2014;57[9]1090-7). Initially, most cases were done with the hand-assist technique. Over time, that percentage dropped precipitously and the number that were performed laparoscopically rose sharply. Throughout the study period, the percentage of open procedures remained very low, dropping to almost zero near the conclusion. “They were able to keep their experience of open surgery quite low by using hand-assisted techniques to help with the tough cases of diverticular disease and get over that learning curve,” said Dr. Paquette.
In colon cancer, the study found that laparoscopic procedures hovered around 50%, while open and hand-assisted techniques tended to be around 20%. The higher incidence of open procedures was probably due to the desire of surgeons to be certain that the entire tumor has been excised. “If you’re in doubt, you don’t compromise on oncology. You do an open procedure if you need to,” said Dr. Paquette.
Another tool available to surgeons is single-incision laparoscopic colectomy, as opposed to conventional multiport laparoscopic colectomy. The method results in a very small incision, but can be challenging because the instruments are closer together and it is tricky when the surgeon has to cross the instrument, he said.
Dr. Paquette’s own group also looked at extraction in hand-assisted sigmoid colectomy, in which the surgeon went in laparoscopically, mobilized the colon laterally as would be done in an open procedure, and then performed the colectomy through a small extraction incision. The length of stay was about 15% shorter, there was a lower readmission rate, and gastrointestinal function returned more quickly (Surg Endosc. 2016 Aug;30[8]:3567-72).
Can patients who previously underwent a midline laparotomy be treated laparoscopically? “The answer is possibly yes,” said Dr. Paquette. He noted one study that showed higher rates of minor morbidity, ileotomy, and longer length of stay with laparoscopic treatment (Surg Endosc. 2015;29[3]537-42). “It’s a worth a try if you carefully plan where you’re going to go in through your ports, get in off the midline somewhere if you have to, and just take a look. If you have some adhesions of the omentum to the abdominal wall, it’s really no problem and you can proceed. If you have a frozen abdomen, just do the right thing and open the patient,” said Dr. Paquette.
When it comes to extraction options, Pfannenstiel incisions have the lowest rates of incisional hernias, at 1.9%, according to a survey of 2,148 cases at the Cleveland Clinic. The periumbilical midline incision had the highest frequency at 16.2% (Dis Colon Rectum. 2016 Aug;59[8]:743-50).
“If I’m doing a laparoscopic sigmoid or a laparoscopic low anterior, I do prefer to do a Pfannenstiel incision if I can. If you think that you may need to convert that patient for some reason, don’t do the Pfannenstiel first – nobody wants that big T-shaped incision,” said Dr. Paquette.
Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Paquette has consulted for Ethicon.
LAS VEGAS – , including reduced hospital length of stay, less pain, faster return to work, and reduced incidence of adhesive small bowel obstructions. But the methods are underutilized, in part because they can be challenging to learn.
There are some tools and methods that can help surgeons perform surgeries laparoscopically, including hand-assisted laparoscopy and the use of single-incision laparoscopic colectomy (SILC). These methods were the subject of a talk at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.
Between 2009 and 2012, a little over 30% of colon cancer cases in the United States and about half of diverticulitis cases were performed laparoscopically. The percentage of laparoscopic procedures ticked up slightly from 2009 to 2012, but only by a few percentage points. “The fact is, we’re just not doing [minimally invasive procedures],” Ian M. Paquette, MD, FACS, associate professor of surgery at the University of Cincinnati, said during his talk.
When a laparoscopic procedure proves challenging, one option is the hand-assist technique. The literature hasn’t been very supportive of the method, with one study of data from the American College of Surgeons National Surgical Quality Improvement Program showing that it offers no improvement in operation time, compared with standard laparoscopy, and that it has slightly higher complication rates (J Gastrointest Surg. 2016 Nov;20[11]:1854-60). “They say you should do everything laparoscopically,” said Dr. Paquette.
One high-volume surgeon showed what happened over time when his practice employed hand-assisted laparoscopy for diverticulitis cases (Dis Colon Rectum. 2014;57[9]1090-7). Initially, most cases were done with the hand-assist technique. Over time, that percentage dropped precipitously and the number that were performed laparoscopically rose sharply. Throughout the study period, the percentage of open procedures remained very low, dropping to almost zero near the conclusion. “They were able to keep their experience of open surgery quite low by using hand-assisted techniques to help with the tough cases of diverticular disease and get over that learning curve,” said Dr. Paquette.
In colon cancer, the study found that laparoscopic procedures hovered around 50%, while open and hand-assisted techniques tended to be around 20%. The higher incidence of open procedures was probably due to the desire of surgeons to be certain that the entire tumor has been excised. “If you’re in doubt, you don’t compromise on oncology. You do an open procedure if you need to,” said Dr. Paquette.
Another tool available to surgeons is single-incision laparoscopic colectomy, as opposed to conventional multiport laparoscopic colectomy. The method results in a very small incision, but can be challenging because the instruments are closer together and it is tricky when the surgeon has to cross the instrument, he said.
Dr. Paquette’s own group also looked at extraction in hand-assisted sigmoid colectomy, in which the surgeon went in laparoscopically, mobilized the colon laterally as would be done in an open procedure, and then performed the colectomy through a small extraction incision. The length of stay was about 15% shorter, there was a lower readmission rate, and gastrointestinal function returned more quickly (Surg Endosc. 2016 Aug;30[8]:3567-72).
Can patients who previously underwent a midline laparotomy be treated laparoscopically? “The answer is possibly yes,” said Dr. Paquette. He noted one study that showed higher rates of minor morbidity, ileotomy, and longer length of stay with laparoscopic treatment (Surg Endosc. 2015;29[3]537-42). “It’s a worth a try if you carefully plan where you’re going to go in through your ports, get in off the midline somewhere if you have to, and just take a look. If you have some adhesions of the omentum to the abdominal wall, it’s really no problem and you can proceed. If you have a frozen abdomen, just do the right thing and open the patient,” said Dr. Paquette.
When it comes to extraction options, Pfannenstiel incisions have the lowest rates of incisional hernias, at 1.9%, according to a survey of 2,148 cases at the Cleveland Clinic. The periumbilical midline incision had the highest frequency at 16.2% (Dis Colon Rectum. 2016 Aug;59[8]:743-50).
“If I’m doing a laparoscopic sigmoid or a laparoscopic low anterior, I do prefer to do a Pfannenstiel incision if I can. If you think that you may need to convert that patient for some reason, don’t do the Pfannenstiel first – nobody wants that big T-shaped incision,” said Dr. Paquette.
Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Paquette has consulted for Ethicon.
LAS VEGAS – , including reduced hospital length of stay, less pain, faster return to work, and reduced incidence of adhesive small bowel obstructions. But the methods are underutilized, in part because they can be challenging to learn.
There are some tools and methods that can help surgeons perform surgeries laparoscopically, including hand-assisted laparoscopy and the use of single-incision laparoscopic colectomy (SILC). These methods were the subject of a talk at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.
Between 2009 and 2012, a little over 30% of colon cancer cases in the United States and about half of diverticulitis cases were performed laparoscopically. The percentage of laparoscopic procedures ticked up slightly from 2009 to 2012, but only by a few percentage points. “The fact is, we’re just not doing [minimally invasive procedures],” Ian M. Paquette, MD, FACS, associate professor of surgery at the University of Cincinnati, said during his talk.
When a laparoscopic procedure proves challenging, one option is the hand-assist technique. The literature hasn’t been very supportive of the method, with one study of data from the American College of Surgeons National Surgical Quality Improvement Program showing that it offers no improvement in operation time, compared with standard laparoscopy, and that it has slightly higher complication rates (J Gastrointest Surg. 2016 Nov;20[11]:1854-60). “They say you should do everything laparoscopically,” said Dr. Paquette.
One high-volume surgeon showed what happened over time when his practice employed hand-assisted laparoscopy for diverticulitis cases (Dis Colon Rectum. 2014;57[9]1090-7). Initially, most cases were done with the hand-assist technique. Over time, that percentage dropped precipitously and the number that were performed laparoscopically rose sharply. Throughout the study period, the percentage of open procedures remained very low, dropping to almost zero near the conclusion. “They were able to keep their experience of open surgery quite low by using hand-assisted techniques to help with the tough cases of diverticular disease and get over that learning curve,” said Dr. Paquette.
In colon cancer, the study found that laparoscopic procedures hovered around 50%, while open and hand-assisted techniques tended to be around 20%. The higher incidence of open procedures was probably due to the desire of surgeons to be certain that the entire tumor has been excised. “If you’re in doubt, you don’t compromise on oncology. You do an open procedure if you need to,” said Dr. Paquette.
Another tool available to surgeons is single-incision laparoscopic colectomy, as opposed to conventional multiport laparoscopic colectomy. The method results in a very small incision, but can be challenging because the instruments are closer together and it is tricky when the surgeon has to cross the instrument, he said.
Dr. Paquette’s own group also looked at extraction in hand-assisted sigmoid colectomy, in which the surgeon went in laparoscopically, mobilized the colon laterally as would be done in an open procedure, and then performed the colectomy through a small extraction incision. The length of stay was about 15% shorter, there was a lower readmission rate, and gastrointestinal function returned more quickly (Surg Endosc. 2016 Aug;30[8]:3567-72).
Can patients who previously underwent a midline laparotomy be treated laparoscopically? “The answer is possibly yes,” said Dr. Paquette. He noted one study that showed higher rates of minor morbidity, ileotomy, and longer length of stay with laparoscopic treatment (Surg Endosc. 2015;29[3]537-42). “It’s a worth a try if you carefully plan where you’re going to go in through your ports, get in off the midline somewhere if you have to, and just take a look. If you have some adhesions of the omentum to the abdominal wall, it’s really no problem and you can proceed. If you have a frozen abdomen, just do the right thing and open the patient,” said Dr. Paquette.
When it comes to extraction options, Pfannenstiel incisions have the lowest rates of incisional hernias, at 1.9%, according to a survey of 2,148 cases at the Cleveland Clinic. The periumbilical midline incision had the highest frequency at 16.2% (Dis Colon Rectum. 2016 Aug;59[8]:743-50).
“If I’m doing a laparoscopic sigmoid or a laparoscopic low anterior, I do prefer to do a Pfannenstiel incision if I can. If you think that you may need to convert that patient for some reason, don’t do the Pfannenstiel first – nobody wants that big T-shaped incision,” said Dr. Paquette.
Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Paquette has consulted for Ethicon.
REPORTING FROM MISS
FDA issues warning to all duodenoscope manufacturers
The Food and Drug Administration on March 9 issued warning letters to all three duodenoscope manufacturers for failing to comply with the requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices.
The warning is part of an ongoing effort to prevent patient infections associated with the transmission of bacteria from contaminated duodenoscopes. The three manufacturers – Olympus, Fujifilm, and Pentax – are required to conduct studies to sample and culture reprocessed duodenoscopes that are in clinical use to learn more about issues that contribute to contamination, and to study human factors to determine how hospital staff who have had training are following the reprocessing instructions. In 2015, the FDA ordered the companies to conduct a postmarket surveillance study to determine whether health care facilities were able to properly clean and disinfect the devices.
Currently, the Olympus manufacturer has failed to start data collection, while both Pentax and Fujifilm have failed to provide sufficient data required for their respective studies to sample and culture reprocessed duodenoscopes that are in clinical use. In addition, Olympus and Pentax have not complied with requirements to assess how well staff members have followed the reprocessing instructions after the human factors studies and Fujifilm has been meeting its requirements for its human factors study only.
“The FDA has taken important steps to improve the reprocessing of duodenoscopes, and we’ve seen a reduction in reports of patient infections, but we need the required postmarket studies to determine whether these measures are being properly implemented in real-world clinical settings and whether we need to take additional action to further improve the safety of these devices,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health in a press release. “We expect these device manufacturers to meet their study obligations to ensure patient safety.”
The companies have until March 24 to submit a plan that outlines how study milestones will be achieved. If the companies fail to respond to the warning letter, the FDA states that they may take additional action, such as seizure, injunction, and civil monetary penalties.
Read the full press release on the FDA’s website.
The Food and Drug Administration on March 9 issued warning letters to all three duodenoscope manufacturers for failing to comply with the requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices.
The warning is part of an ongoing effort to prevent patient infections associated with the transmission of bacteria from contaminated duodenoscopes. The three manufacturers – Olympus, Fujifilm, and Pentax – are required to conduct studies to sample and culture reprocessed duodenoscopes that are in clinical use to learn more about issues that contribute to contamination, and to study human factors to determine how hospital staff who have had training are following the reprocessing instructions. In 2015, the FDA ordered the companies to conduct a postmarket surveillance study to determine whether health care facilities were able to properly clean and disinfect the devices.
Currently, the Olympus manufacturer has failed to start data collection, while both Pentax and Fujifilm have failed to provide sufficient data required for their respective studies to sample and culture reprocessed duodenoscopes that are in clinical use. In addition, Olympus and Pentax have not complied with requirements to assess how well staff members have followed the reprocessing instructions after the human factors studies and Fujifilm has been meeting its requirements for its human factors study only.
“The FDA has taken important steps to improve the reprocessing of duodenoscopes, and we’ve seen a reduction in reports of patient infections, but we need the required postmarket studies to determine whether these measures are being properly implemented in real-world clinical settings and whether we need to take additional action to further improve the safety of these devices,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health in a press release. “We expect these device manufacturers to meet their study obligations to ensure patient safety.”
The companies have until March 24 to submit a plan that outlines how study milestones will be achieved. If the companies fail to respond to the warning letter, the FDA states that they may take additional action, such as seizure, injunction, and civil monetary penalties.
Read the full press release on the FDA’s website.
The Food and Drug Administration on March 9 issued warning letters to all three duodenoscope manufacturers for failing to comply with the requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices.
The warning is part of an ongoing effort to prevent patient infections associated with the transmission of bacteria from contaminated duodenoscopes. The three manufacturers – Olympus, Fujifilm, and Pentax – are required to conduct studies to sample and culture reprocessed duodenoscopes that are in clinical use to learn more about issues that contribute to contamination, and to study human factors to determine how hospital staff who have had training are following the reprocessing instructions. In 2015, the FDA ordered the companies to conduct a postmarket surveillance study to determine whether health care facilities were able to properly clean and disinfect the devices.
Currently, the Olympus manufacturer has failed to start data collection, while both Pentax and Fujifilm have failed to provide sufficient data required for their respective studies to sample and culture reprocessed duodenoscopes that are in clinical use. In addition, Olympus and Pentax have not complied with requirements to assess how well staff members have followed the reprocessing instructions after the human factors studies and Fujifilm has been meeting its requirements for its human factors study only.
“The FDA has taken important steps to improve the reprocessing of duodenoscopes, and we’ve seen a reduction in reports of patient infections, but we need the required postmarket studies to determine whether these measures are being properly implemented in real-world clinical settings and whether we need to take additional action to further improve the safety of these devices,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health in a press release. “We expect these device manufacturers to meet their study obligations to ensure patient safety.”
The companies have until March 24 to submit a plan that outlines how study milestones will be achieved. If the companies fail to respond to the warning letter, the FDA states that they may take additional action, such as seizure, injunction, and civil monetary penalties.
Read the full press release on the FDA’s website.
IBD: When to operate and when to punt
LAS VEGAS – Patients with inflammatory bowel disease who are in need of a surgical intervention can pose a special challenge to surgeons who encounter these patients only occasionally.
The question of whether to perform surgery or refer a patient to a higher-volume specialty center can depend on proximity. In some cases, a specialty center isn’t close, or the patient can’t tolerate the required travel. In fact, a recent study showed that 85.8% of IBD patients are treated surgically in hospitals that treat fewer than 50 patients per year (Am J Gastroenterol. 2008;103:2789-98).
In a presentation at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education, Larry Whelan, MD, FACS, discussed some of the challenges these patients pose and offered guidance on which cases are best referred to high-volume centers, and the best way to proceed in emergencies.
IBD patients at high-volume centers have lower mortality than do those in low-volume centers, but patients treated at lower-volume centers tend to be sicker, and studies have shown no significant difference in complication rate. This suggests that surgeons shouldn’t be afraid to tackle these cases, according to Dr. Whelan, chief of colorectal surgery at Mount Sinai West, New York.
"If you get an IBD case and you don’t see a lot of those, how do you decide what to do about it, and should you just refer it to a high-volume center?” said Dr. Whelan.
These patients are often under complex medical management, frequently spanning years, and this is an important factor in surgical decisions. They are often on multiple medications, including steroids, and most patients these days are taking monoclonal antibodies, said Dr. Whelan. The latter in particular can lead patients to be susceptible to infections. “These things can all affect decision making,” said Dr. Whelan.
Sometimes the nutritional status of IBD patients is poor, and most of the time, surgery is elective in these patients. So surgery can often be delayed for a month or more to allow time for nutritional status to improve, and this gives time for a patient to go off monoclonal antibodies, and for the physician to arrange for a referral to a high-volume center, if that seems the wisest course.
Surgery should not be considered without a gastrointestinal specialist who is comfortable in managing these patients. “Having someone who knows when to operate and not to operate, and how to handle medication, is really important,” said Dr. Whelan.
Certain cases should definitely be referred out. Ileal pouches are one. Another is a Crohn’s disease patient with multiple points of obstruction. “That may be one that you’re better off to punt,” said Dr. Whelan. Other cases include patients under complex medical management, when there is no experienced GI specialist available to help.
Emergencies require quicker decisions. In ulcerative colitis, emergency cases may include toxic megacolon, perforated colon, or obstruction from either a stricture or cancer, as well as bleeding in rare cases. Scenarios in Crohn’s disease include perforation with sepsis, inaccessible abscess, and, most commonly, obstruction resulting from fibrous stricture or acute inflammation.
When surgery is required, what’s the best choice? Dr. Whelan emphasized keeping it simple. Redo ileal pouches and ileal pouch excisions should generally be avoided. “Even if you do [pouches] often. It’s not the smartest way to go. These patients are almost all on immunosuppressive medications … to make an operation that’s already big even bigger often doesn’t work out well,” he said.
In emergency chronic ulcerative colitis cases, the safest choice is total abdominal colectomy plus end ileostomy. Dr. Whelan discourages surgeons from considering proctectomy and ileal pouch in emergency cases. A number of studies have shown that delaying pouch surgery is associated with fewer minor and major adverse events, and lower reoperation rates, he said. “If you do these operations on an immunosuppressed population, they don’t do as well,” said Dr. Whelan.
Crohn’s disease emergencies can often be managed nonsurgically. Most patients have phlegmon, fistulae, or a partial obstruction. Intravenous antibiotics, percutaneous drainage, hydration, and boosting nutritional status are good options. In cases where an obstruction requires surgery, and the surgeon isn’t comfortable performing stricturoplasty, “you want to limit the resection as best you can,” he said.
Dr. Whelan disclosed financial relationships with Ethicon Endosurgery and Olympus Corporation. Global Academy for Medical Education and this news organization are owned by the same parent company.”
LAS VEGAS – Patients with inflammatory bowel disease who are in need of a surgical intervention can pose a special challenge to surgeons who encounter these patients only occasionally.
The question of whether to perform surgery or refer a patient to a higher-volume specialty center can depend on proximity. In some cases, a specialty center isn’t close, or the patient can’t tolerate the required travel. In fact, a recent study showed that 85.8% of IBD patients are treated surgically in hospitals that treat fewer than 50 patients per year (Am J Gastroenterol. 2008;103:2789-98).
In a presentation at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education, Larry Whelan, MD, FACS, discussed some of the challenges these patients pose and offered guidance on which cases are best referred to high-volume centers, and the best way to proceed in emergencies.
IBD patients at high-volume centers have lower mortality than do those in low-volume centers, but patients treated at lower-volume centers tend to be sicker, and studies have shown no significant difference in complication rate. This suggests that surgeons shouldn’t be afraid to tackle these cases, according to Dr. Whelan, chief of colorectal surgery at Mount Sinai West, New York.
"If you get an IBD case and you don’t see a lot of those, how do you decide what to do about it, and should you just refer it to a high-volume center?” said Dr. Whelan.
These patients are often under complex medical management, frequently spanning years, and this is an important factor in surgical decisions. They are often on multiple medications, including steroids, and most patients these days are taking monoclonal antibodies, said Dr. Whelan. The latter in particular can lead patients to be susceptible to infections. “These things can all affect decision making,” said Dr. Whelan.
Sometimes the nutritional status of IBD patients is poor, and most of the time, surgery is elective in these patients. So surgery can often be delayed for a month or more to allow time for nutritional status to improve, and this gives time for a patient to go off monoclonal antibodies, and for the physician to arrange for a referral to a high-volume center, if that seems the wisest course.
Surgery should not be considered without a gastrointestinal specialist who is comfortable in managing these patients. “Having someone who knows when to operate and not to operate, and how to handle medication, is really important,” said Dr. Whelan.
Certain cases should definitely be referred out. Ileal pouches are one. Another is a Crohn’s disease patient with multiple points of obstruction. “That may be one that you’re better off to punt,” said Dr. Whelan. Other cases include patients under complex medical management, when there is no experienced GI specialist available to help.
Emergencies require quicker decisions. In ulcerative colitis, emergency cases may include toxic megacolon, perforated colon, or obstruction from either a stricture or cancer, as well as bleeding in rare cases. Scenarios in Crohn’s disease include perforation with sepsis, inaccessible abscess, and, most commonly, obstruction resulting from fibrous stricture or acute inflammation.
When surgery is required, what’s the best choice? Dr. Whelan emphasized keeping it simple. Redo ileal pouches and ileal pouch excisions should generally be avoided. “Even if you do [pouches] often. It’s not the smartest way to go. These patients are almost all on immunosuppressive medications … to make an operation that’s already big even bigger often doesn’t work out well,” he said.
In emergency chronic ulcerative colitis cases, the safest choice is total abdominal colectomy plus end ileostomy. Dr. Whelan discourages surgeons from considering proctectomy and ileal pouch in emergency cases. A number of studies have shown that delaying pouch surgery is associated with fewer minor and major adverse events, and lower reoperation rates, he said. “If you do these operations on an immunosuppressed population, they don’t do as well,” said Dr. Whelan.
Crohn’s disease emergencies can often be managed nonsurgically. Most patients have phlegmon, fistulae, or a partial obstruction. Intravenous antibiotics, percutaneous drainage, hydration, and boosting nutritional status are good options. In cases where an obstruction requires surgery, and the surgeon isn’t comfortable performing stricturoplasty, “you want to limit the resection as best you can,” he said.
Dr. Whelan disclosed financial relationships with Ethicon Endosurgery and Olympus Corporation. Global Academy for Medical Education and this news organization are owned by the same parent company.”
LAS VEGAS – Patients with inflammatory bowel disease who are in need of a surgical intervention can pose a special challenge to surgeons who encounter these patients only occasionally.
The question of whether to perform surgery or refer a patient to a higher-volume specialty center can depend on proximity. In some cases, a specialty center isn’t close, or the patient can’t tolerate the required travel. In fact, a recent study showed that 85.8% of IBD patients are treated surgically in hospitals that treat fewer than 50 patients per year (Am J Gastroenterol. 2008;103:2789-98).
In a presentation at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education, Larry Whelan, MD, FACS, discussed some of the challenges these patients pose and offered guidance on which cases are best referred to high-volume centers, and the best way to proceed in emergencies.
IBD patients at high-volume centers have lower mortality than do those in low-volume centers, but patients treated at lower-volume centers tend to be sicker, and studies have shown no significant difference in complication rate. This suggests that surgeons shouldn’t be afraid to tackle these cases, according to Dr. Whelan, chief of colorectal surgery at Mount Sinai West, New York.
"If you get an IBD case and you don’t see a lot of those, how do you decide what to do about it, and should you just refer it to a high-volume center?” said Dr. Whelan.
These patients are often under complex medical management, frequently spanning years, and this is an important factor in surgical decisions. They are often on multiple medications, including steroids, and most patients these days are taking monoclonal antibodies, said Dr. Whelan. The latter in particular can lead patients to be susceptible to infections. “These things can all affect decision making,” said Dr. Whelan.
Sometimes the nutritional status of IBD patients is poor, and most of the time, surgery is elective in these patients. So surgery can often be delayed for a month or more to allow time for nutritional status to improve, and this gives time for a patient to go off monoclonal antibodies, and for the physician to arrange for a referral to a high-volume center, if that seems the wisest course.
Surgery should not be considered without a gastrointestinal specialist who is comfortable in managing these patients. “Having someone who knows when to operate and not to operate, and how to handle medication, is really important,” said Dr. Whelan.
Certain cases should definitely be referred out. Ileal pouches are one. Another is a Crohn’s disease patient with multiple points of obstruction. “That may be one that you’re better off to punt,” said Dr. Whelan. Other cases include patients under complex medical management, when there is no experienced GI specialist available to help.
Emergencies require quicker decisions. In ulcerative colitis, emergency cases may include toxic megacolon, perforated colon, or obstruction from either a stricture or cancer, as well as bleeding in rare cases. Scenarios in Crohn’s disease include perforation with sepsis, inaccessible abscess, and, most commonly, obstruction resulting from fibrous stricture or acute inflammation.
When surgery is required, what’s the best choice? Dr. Whelan emphasized keeping it simple. Redo ileal pouches and ileal pouch excisions should generally be avoided. “Even if you do [pouches] often. It’s not the smartest way to go. These patients are almost all on immunosuppressive medications … to make an operation that’s already big even bigger often doesn’t work out well,” he said.
In emergency chronic ulcerative colitis cases, the safest choice is total abdominal colectomy plus end ileostomy. Dr. Whelan discourages surgeons from considering proctectomy and ileal pouch in emergency cases. A number of studies have shown that delaying pouch surgery is associated with fewer minor and major adverse events, and lower reoperation rates, he said. “If you do these operations on an immunosuppressed population, they don’t do as well,” said Dr. Whelan.
Crohn’s disease emergencies can often be managed nonsurgically. Most patients have phlegmon, fistulae, or a partial obstruction. Intravenous antibiotics, percutaneous drainage, hydration, and boosting nutritional status are good options. In cases where an obstruction requires surgery, and the surgeon isn’t comfortable performing stricturoplasty, “you want to limit the resection as best you can,” he said.
Dr. Whelan disclosed financial relationships with Ethicon Endosurgery and Olympus Corporation. Global Academy for Medical Education and this news organization are owned by the same parent company.”
EXPERT ANALYSIS FROM MISS
Haloperidol does not prevent delirium in ICU patients
of 1,789 critically ill adults at 21 ICUs in the Netherlands.
Haloperidol is used routinely in ICUs to both treat and prevent delirium, which strikes up to half of ICU patients and is associated with prolonged mechanical ventilation, longer ICU and hospital stays, and increased mortality. Results of past studies have been mixed, with some showing a benefit for haloperidol in the ICU and others not.
“These findings do not support the use of prophylactic haloperidol in critically ill adults,” said the authors of a new study, led by Mark van den Boogaard, PhD, of Radboud University Medical Center, Nijmegen, the Netherlands (JAMA. 2018 Feb 20;319[7]:680-90).
The subjects were all expected to be in the ICU for at least 2 days, and were not delirious at baseline. The patients were randomly assigned to receive one of two treatments or a placebo three times daily, with 350 receiving 1 mg of haloperidol; 732 receiving 2 mg of haloperidol; and 707 receiving a 0.9% sodium chloride placebo. The 1-mg haloperidol arm was stopped early because of futility.
There was no statistically significant difference in survival at the primary endpoint of 28 days following entrance into the study. At that point, 83.3% of the patients who received 2-mg does of haloperidol and 82.7% of the of the subjects who received the placebo were alive (absolute difference 0.6%, 95% confidence interval –3.4% to 4.6%).
Prophylactic haloperidol had no effect on reducing the incidence of delirium, which was diagnosed in 33.3% of haloperidol subjects and 33.0% of placebo patients. Likewise, there were no significant differences between the groups in the number of delirium-free and coma-free days, duration of mechanical ventilation, and ICU and hospital length of stay. The number of reported adverse events with treatment also did not differ significantly between the groups: 0.3% in the 2-mg haloperidol group versus 0.1% in the placebo arm.
The duration of prophylactic therapy was a median of 2 days, but a subgroup analysis in patients treated for more than 2 days also did not show any benefits with haloperidol.
“The study population included severely ill ICU adults whose brains may have been too seriously affected for haloperidol to exert a prophylactic effect, since in non-ICU adults, prophylactic haloperidol may have beneficial effects. But the subgroup of patients with a low severity of illness score also demonstrated no beneficial effects,” the investigators said.
Subjects were a mean of 66.6 years old; 61.4% were men. Most of the ICU admissions were urgent and for medical or surgical reasons.
This study was supported by ZonMw, the Netherlands Organization for Health Research and Development. Dr. van den Boogaard had no disclosures. One author reported grants and consultant and speaker fees from Pfizer, Merck, Astellas, and Gilead, among others.
SOURCE: van den Boogaard M, et al. JAMA. 2018 Feb 20;319(7):680-90.
The study has demonstrated that in critically ill patients currently receiving best-practice nonpharmacological interventions to prevent delirium, the addition of haloperidol does not improve survival nor reduce the incidence of delirium or the harms associated with delirium. The findings challenge the current model that the addition of psychoactive medication to patients who are already receiving multiple interventions may be beneficial. Prophylactic haloperidol is not the solution for the complex problem of delirium in critically ill patients. It may be that no single pharmacological intervention can provide a solution.
Future research is warranted into nonpharmacological interventions. They generally involve either doing less for patients (avoiding excessive sedation, benzodiazepines, nocturnal noise, and stimulation) or ensuring the continued provision of relatively simple therapies (mobilization, maintaining a day-night schedule, and noise reduction). Although some of these interventions may require planning and cooperation of a multidisciplinary team, a strength of ICU care in general, other interventions may be as simple as providing earplugs and eye patches to improve sleep.
Anthony Delaney, MD, PhD, is associate professor of intensive care medicine at the University of Sydney. Naomi Hammond, PhD, is a research fellow and senior lecturer at the University of New South Wales, Sydney. Edward Litton, MD, PhD, is an intensive care specialist in Perth, Australia. They made their comments in a JAMA editorial, and had no disclosures ( JAMA. 2018 Feb 20;319[7]:659-60 ).
The study has demonstrated that in critically ill patients currently receiving best-practice nonpharmacological interventions to prevent delirium, the addition of haloperidol does not improve survival nor reduce the incidence of delirium or the harms associated with delirium. The findings challenge the current model that the addition of psychoactive medication to patients who are already receiving multiple interventions may be beneficial. Prophylactic haloperidol is not the solution for the complex problem of delirium in critically ill patients. It may be that no single pharmacological intervention can provide a solution.
Future research is warranted into nonpharmacological interventions. They generally involve either doing less for patients (avoiding excessive sedation, benzodiazepines, nocturnal noise, and stimulation) or ensuring the continued provision of relatively simple therapies (mobilization, maintaining a day-night schedule, and noise reduction). Although some of these interventions may require planning and cooperation of a multidisciplinary team, a strength of ICU care in general, other interventions may be as simple as providing earplugs and eye patches to improve sleep.
Anthony Delaney, MD, PhD, is associate professor of intensive care medicine at the University of Sydney. Naomi Hammond, PhD, is a research fellow and senior lecturer at the University of New South Wales, Sydney. Edward Litton, MD, PhD, is an intensive care specialist in Perth, Australia. They made their comments in a JAMA editorial, and had no disclosures ( JAMA. 2018 Feb 20;319[7]:659-60 ).
The study has demonstrated that in critically ill patients currently receiving best-practice nonpharmacological interventions to prevent delirium, the addition of haloperidol does not improve survival nor reduce the incidence of delirium or the harms associated with delirium. The findings challenge the current model that the addition of psychoactive medication to patients who are already receiving multiple interventions may be beneficial. Prophylactic haloperidol is not the solution for the complex problem of delirium in critically ill patients. It may be that no single pharmacological intervention can provide a solution.
Future research is warranted into nonpharmacological interventions. They generally involve either doing less for patients (avoiding excessive sedation, benzodiazepines, nocturnal noise, and stimulation) or ensuring the continued provision of relatively simple therapies (mobilization, maintaining a day-night schedule, and noise reduction). Although some of these interventions may require planning and cooperation of a multidisciplinary team, a strength of ICU care in general, other interventions may be as simple as providing earplugs and eye patches to improve sleep.
Anthony Delaney, MD, PhD, is associate professor of intensive care medicine at the University of Sydney. Naomi Hammond, PhD, is a research fellow and senior lecturer at the University of New South Wales, Sydney. Edward Litton, MD, PhD, is an intensive care specialist in Perth, Australia. They made their comments in a JAMA editorial, and had no disclosures ( JAMA. 2018 Feb 20;319[7]:659-60 ).
of 1,789 critically ill adults at 21 ICUs in the Netherlands.
Haloperidol is used routinely in ICUs to both treat and prevent delirium, which strikes up to half of ICU patients and is associated with prolonged mechanical ventilation, longer ICU and hospital stays, and increased mortality. Results of past studies have been mixed, with some showing a benefit for haloperidol in the ICU and others not.
“These findings do not support the use of prophylactic haloperidol in critically ill adults,” said the authors of a new study, led by Mark van den Boogaard, PhD, of Radboud University Medical Center, Nijmegen, the Netherlands (JAMA. 2018 Feb 20;319[7]:680-90).
The subjects were all expected to be in the ICU for at least 2 days, and were not delirious at baseline. The patients were randomly assigned to receive one of two treatments or a placebo three times daily, with 350 receiving 1 mg of haloperidol; 732 receiving 2 mg of haloperidol; and 707 receiving a 0.9% sodium chloride placebo. The 1-mg haloperidol arm was stopped early because of futility.
There was no statistically significant difference in survival at the primary endpoint of 28 days following entrance into the study. At that point, 83.3% of the patients who received 2-mg does of haloperidol and 82.7% of the of the subjects who received the placebo were alive (absolute difference 0.6%, 95% confidence interval –3.4% to 4.6%).
Prophylactic haloperidol had no effect on reducing the incidence of delirium, which was diagnosed in 33.3% of haloperidol subjects and 33.0% of placebo patients. Likewise, there were no significant differences between the groups in the number of delirium-free and coma-free days, duration of mechanical ventilation, and ICU and hospital length of stay. The number of reported adverse events with treatment also did not differ significantly between the groups: 0.3% in the 2-mg haloperidol group versus 0.1% in the placebo arm.
The duration of prophylactic therapy was a median of 2 days, but a subgroup analysis in patients treated for more than 2 days also did not show any benefits with haloperidol.
“The study population included severely ill ICU adults whose brains may have been too seriously affected for haloperidol to exert a prophylactic effect, since in non-ICU adults, prophylactic haloperidol may have beneficial effects. But the subgroup of patients with a low severity of illness score also demonstrated no beneficial effects,” the investigators said.
Subjects were a mean of 66.6 years old; 61.4% were men. Most of the ICU admissions were urgent and for medical or surgical reasons.
This study was supported by ZonMw, the Netherlands Organization for Health Research and Development. Dr. van den Boogaard had no disclosures. One author reported grants and consultant and speaker fees from Pfizer, Merck, Astellas, and Gilead, among others.
SOURCE: van den Boogaard M, et al. JAMA. 2018 Feb 20;319(7):680-90.
of 1,789 critically ill adults at 21 ICUs in the Netherlands.
Haloperidol is used routinely in ICUs to both treat and prevent delirium, which strikes up to half of ICU patients and is associated with prolonged mechanical ventilation, longer ICU and hospital stays, and increased mortality. Results of past studies have been mixed, with some showing a benefit for haloperidol in the ICU and others not.
“These findings do not support the use of prophylactic haloperidol in critically ill adults,” said the authors of a new study, led by Mark van den Boogaard, PhD, of Radboud University Medical Center, Nijmegen, the Netherlands (JAMA. 2018 Feb 20;319[7]:680-90).
The subjects were all expected to be in the ICU for at least 2 days, and were not delirious at baseline. The patients were randomly assigned to receive one of two treatments or a placebo three times daily, with 350 receiving 1 mg of haloperidol; 732 receiving 2 mg of haloperidol; and 707 receiving a 0.9% sodium chloride placebo. The 1-mg haloperidol arm was stopped early because of futility.
There was no statistically significant difference in survival at the primary endpoint of 28 days following entrance into the study. At that point, 83.3% of the patients who received 2-mg does of haloperidol and 82.7% of the of the subjects who received the placebo were alive (absolute difference 0.6%, 95% confidence interval –3.4% to 4.6%).
Prophylactic haloperidol had no effect on reducing the incidence of delirium, which was diagnosed in 33.3% of haloperidol subjects and 33.0% of placebo patients. Likewise, there were no significant differences between the groups in the number of delirium-free and coma-free days, duration of mechanical ventilation, and ICU and hospital length of stay. The number of reported adverse events with treatment also did not differ significantly between the groups: 0.3% in the 2-mg haloperidol group versus 0.1% in the placebo arm.
The duration of prophylactic therapy was a median of 2 days, but a subgroup analysis in patients treated for more than 2 days also did not show any benefits with haloperidol.
“The study population included severely ill ICU adults whose brains may have been too seriously affected for haloperidol to exert a prophylactic effect, since in non-ICU adults, prophylactic haloperidol may have beneficial effects. But the subgroup of patients with a low severity of illness score also demonstrated no beneficial effects,” the investigators said.
Subjects were a mean of 66.6 years old; 61.4% were men. Most of the ICU admissions were urgent and for medical or surgical reasons.
This study was supported by ZonMw, the Netherlands Organization for Health Research and Development. Dr. van den Boogaard had no disclosures. One author reported grants and consultant and speaker fees from Pfizer, Merck, Astellas, and Gilead, among others.
SOURCE: van den Boogaard M, et al. JAMA. 2018 Feb 20;319(7):680-90.
FROM JAMA
Key clinical point: Prophylactic haloperidol did not prevent delirium or improve survival in a large, placebo-controlled trial at 21 ICUs in the Netherlands.
Major finding: Delirium was diagnosed in 33.3% of haloperidol subjects versus 33.0% of placebo patients.
Study details: The trial enrolled 1,789 critically ill adults.
Disclosures: This work was supported by ZonMw, the Netherlands Organization for Health Research and Development. The lead investigator had no disclosures.
Source: van den Boogaard M et al. JAMA. 2018 Feb 20;319(7):680-90.
Never too late to operate? Surgery near end of life is common, costly
At 87, Maxine Stanich cared more about improving the quality of her life than prolonging it.
She suffered from a long list of health problems, including heart failure and chronic lung disease that could leave her gasping for breath.
When her time came, she wanted to die a natural death, Stanich told her daughter, and signed a “do not resuscitate” directive, or DNR, ordering doctors not to revive her should her heart stop.
Yet a trip to a San Francisco emergency room for shortness of breath in 2008 led Stanich to get a defibrillator implanted in her chest – a medical device to keep her alive by delivering a powerful shock. At the time, Stanich didn’t fully grasp what she had agreed to, even though she signed a document granting permission for the procedure, said her daughter, Susan Giaquinto.
That clarity came only during a subsequent visit to a different hospital, when a surprised ER doctor saw a defibrillator protruding from the DNR patient’s thin chest. To Stanich’s horror, the ER doctor explained that the device would not allow her to slip away painlessly and that the jolt would be “so strong that it will knock her across the room,” said Giaquinto, who accompanied her mother on both hospital trips.
Surgery like this has become all too common among those near the end of life, experts say. Nearly one in three Medicare patients undergo an operation in the year before they die, even though the evidence shows that many are more likely to be harmed than to benefit from it.
The practice is driven by financial incentives that reward doctors for doing procedures, as well as a medical culture in which patients and doctors are reluctant to talk about how surgical interventions should be prescribed more judiciously, said Rita Redberg, M.D., a cardiologist who treated Stanich when she sought care at the second hospital.
“We have a culture that believes in very aggressive care,” said Dr. Redberg, who at the University of California–San Francisco specializes in heart disease in women. “We are often not considering the chance of benefit and chance of harm, and how that changes when you get older. We also fail to have conversations about what patients value most.”
While surgery is typically lifesaving for younger people, operating on frail, older patients rarely helps them live longer or returns the quality of life they once enjoyed, according to a 2016 paper in Annals of Surgery.
The cost of these surgeries – typically paid for by Medicare, the government health insurance program for people over 65 – involve more than money, said Amber Barnato, MD, professor at the Dartmouth Institute for Health Policy and Clinical Practice. Older patients who undergo surgery within a year of death spent 50 percent more time in the hospital than others, and nearly twice as many days in intensive care.
And while some robust octogenarians have many years ahead of them, studies show that surgery is also common among those who are far more frail.
Eighteen percent of Medicare patients have surgery in their final month of life and 8% in their final week, according to a 2011 study in The Lancet.
More than 12% of defibrillators were implanted in people older than 80, according to a 2015 study. Doctors implant about 158,000 of the devices each year, according to the American College of Cardiology. The total cost of the procedure runs about $60,000.
Procedures performed in the elderly range from major operations that require lengthy recoveries to relatively minor surgery performed in a doctor’s office, such as the removal of nonfatal skin cancers, that would likely never cause any problems.
Research led by Eleni Linos, MD, has shown that people with limited life expectancies are treated for nonfatal skin cancers as aggressively as younger patients. Among patients with a nonfatal skin cancer and a limited time to live, 70 percent underwent surgery, according to her 2013 study in JAMA Internal Medicine.
When less is more
Surgery poses serious risks for older people, who weather anesthesia poorly and whose skin takes longer to heal. Among seniors who undergo urgent or emergency abdominal surgery, 20% die within 30 days, studies show.
With diminished mental acuity and an old-fashioned respect for the medical profession, some aging patients are vulnerable to unwanted interventions. Stanich agreed to a pacemaker simply because her doctor suggested it, Giaquinto said. Many people of Stanich’s generation “thought doctors were God … They never questioned doctors – ever.”
Margaret Schwarze, MD, a surgeon and associate professor at the University of Wisconsin, said that older patients often don’t feel the financial pain of surgery because insurance pays most of the cost.
When a surgeon offers to “fix” the heart valve in a person with multiple diseases, for example, the patient may assume that surgery will fix all of her medical problems, Dr. Schwarze said. “With older patients with lots of chronic illnesses, we’re not really fixing anything.”
Even as a doctor, Dr. Redberg said, she struggles to prevent other doctors from performing too many procedures on her 92-year-old mother, Mae, who lives in New York City.
Dr. Redberg said doctors recently treated her mother for melanoma – the most serious type of skin cancer. After the cancer was removed from her leg, Dr. Redberg’s mother was urged by a doctor to undergo an additional surgery to cut away more tissue and nearby lymph nodes, which can harbor cancerous cells.
“Every time she went in, the dermatologist wanted to refer her to a surgeon,” Dr. Redberg said. And “Medicare would have been happy to pay for it.”
But her mother often has problems with wounds healing, she said, and recovery would likely have taken 3 months. When Dr. Redberg pressed a surgeon about the benefits, he said the procedure could reduce the chances of cancer coming back within 3-5 years.
Dr. Redberg said her mother laughed and said, “I’m not interested in doing something that will help me in 3-5 years. I doubt I’ll be here.”
Finding solutions
The momentum of hospital care can make people feel as if they’re on a moving train and can’t jump off.
The rush of medical decisions “doesn’t allow time to deliberate or consider the patients’ overall health or what their goals and values might be,” said Jacqueline Kruser, MD, an instructor in pulmonary and critical care medicine and medical social sciences at the Northwestern University.
Many hospitals and health systems are developing “decision aids,” easy-to-understand written materials and videos to help patients make more informed medical decisions, giving them time to develop more realistic expectations.
After Kaiser Permanente Washington introduced the tools relating to joint replacement, the number of patients choosing to have hip replacement surgery fell 26%, while knee replacements declined 38%, according to a study in Health Affairs. (Kaiser Permanente is not affiliated with Kaiser Health News, which is an editorially independent program of the Kaiser Family Foundation.)
In a paper published last year in JAMA Surgery and the Journal of Pain and Symptom Management, Dr. Schwarze, Dr. Kruser and colleagues suggested creating narratives to illustrate surgical risks, rather than relying on statistics.
Instead of telling patients that surgery carries a 20% risk of stroke, for example, doctors should lay out the best, worst and most likely outcomes.
In the best-case scenario, a patient might spend weeks in the hospital after surgery, living the rest of her life in a nursing home. In the worst case, the same patient dies after several weeks in intensive care. In the most likely scenario, the patient survives just 2-3 months after surgery.
Dr. Schwarze said, “If someone says they can’t tolerate the best-case scenario – which involves them being in a nursing home – then maybe we shouldn’t be doing this.”
Maxine Stanich was admitted to the hospital after going to the ER because she felt short of breath. She experienced an abnormal heart rhythm in the procedure room during a cardiac test – not an unusual event during a procedure in which a wire is threaded into the heart. Based on that, doctors decided to implant a pacemaker and defibrillator the next day.
Dr. Redberg was consulted when the patient objected to the device that was now embedded in her chest. She was “very alert. She was very clear about what she did and did not want done. She told me she didn’t want to be shocked,” Redberg said.
After Dr. Redberg deactivated the defibrillator, which can be reprogrammed remotely, Stanich was discharged, with home hospice service. With nothing more than her medicines, she survived another 2 years and 3 months, dying at home just after her 90th birthday in 2010.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN’s coverage related to aging and improving care of older adults is supported in part by The John A. Hartford Foundation.
At 87, Maxine Stanich cared more about improving the quality of her life than prolonging it.
She suffered from a long list of health problems, including heart failure and chronic lung disease that could leave her gasping for breath.
When her time came, she wanted to die a natural death, Stanich told her daughter, and signed a “do not resuscitate” directive, or DNR, ordering doctors not to revive her should her heart stop.
Yet a trip to a San Francisco emergency room for shortness of breath in 2008 led Stanich to get a defibrillator implanted in her chest – a medical device to keep her alive by delivering a powerful shock. At the time, Stanich didn’t fully grasp what she had agreed to, even though she signed a document granting permission for the procedure, said her daughter, Susan Giaquinto.
That clarity came only during a subsequent visit to a different hospital, when a surprised ER doctor saw a defibrillator protruding from the DNR patient’s thin chest. To Stanich’s horror, the ER doctor explained that the device would not allow her to slip away painlessly and that the jolt would be “so strong that it will knock her across the room,” said Giaquinto, who accompanied her mother on both hospital trips.
Surgery like this has become all too common among those near the end of life, experts say. Nearly one in three Medicare patients undergo an operation in the year before they die, even though the evidence shows that many are more likely to be harmed than to benefit from it.
The practice is driven by financial incentives that reward doctors for doing procedures, as well as a medical culture in which patients and doctors are reluctant to talk about how surgical interventions should be prescribed more judiciously, said Rita Redberg, M.D., a cardiologist who treated Stanich when she sought care at the second hospital.
“We have a culture that believes in very aggressive care,” said Dr. Redberg, who at the University of California–San Francisco specializes in heart disease in women. “We are often not considering the chance of benefit and chance of harm, and how that changes when you get older. We also fail to have conversations about what patients value most.”
While surgery is typically lifesaving for younger people, operating on frail, older patients rarely helps them live longer or returns the quality of life they once enjoyed, according to a 2016 paper in Annals of Surgery.
The cost of these surgeries – typically paid for by Medicare, the government health insurance program for people over 65 – involve more than money, said Amber Barnato, MD, professor at the Dartmouth Institute for Health Policy and Clinical Practice. Older patients who undergo surgery within a year of death spent 50 percent more time in the hospital than others, and nearly twice as many days in intensive care.
And while some robust octogenarians have many years ahead of them, studies show that surgery is also common among those who are far more frail.
Eighteen percent of Medicare patients have surgery in their final month of life and 8% in their final week, according to a 2011 study in The Lancet.
More than 12% of defibrillators were implanted in people older than 80, according to a 2015 study. Doctors implant about 158,000 of the devices each year, according to the American College of Cardiology. The total cost of the procedure runs about $60,000.
Procedures performed in the elderly range from major operations that require lengthy recoveries to relatively minor surgery performed in a doctor’s office, such as the removal of nonfatal skin cancers, that would likely never cause any problems.
Research led by Eleni Linos, MD, has shown that people with limited life expectancies are treated for nonfatal skin cancers as aggressively as younger patients. Among patients with a nonfatal skin cancer and a limited time to live, 70 percent underwent surgery, according to her 2013 study in JAMA Internal Medicine.
When less is more
Surgery poses serious risks for older people, who weather anesthesia poorly and whose skin takes longer to heal. Among seniors who undergo urgent or emergency abdominal surgery, 20% die within 30 days, studies show.
With diminished mental acuity and an old-fashioned respect for the medical profession, some aging patients are vulnerable to unwanted interventions. Stanich agreed to a pacemaker simply because her doctor suggested it, Giaquinto said. Many people of Stanich’s generation “thought doctors were God … They never questioned doctors – ever.”
Margaret Schwarze, MD, a surgeon and associate professor at the University of Wisconsin, said that older patients often don’t feel the financial pain of surgery because insurance pays most of the cost.
When a surgeon offers to “fix” the heart valve in a person with multiple diseases, for example, the patient may assume that surgery will fix all of her medical problems, Dr. Schwarze said. “With older patients with lots of chronic illnesses, we’re not really fixing anything.”
Even as a doctor, Dr. Redberg said, she struggles to prevent other doctors from performing too many procedures on her 92-year-old mother, Mae, who lives in New York City.
Dr. Redberg said doctors recently treated her mother for melanoma – the most serious type of skin cancer. After the cancer was removed from her leg, Dr. Redberg’s mother was urged by a doctor to undergo an additional surgery to cut away more tissue and nearby lymph nodes, which can harbor cancerous cells.
“Every time she went in, the dermatologist wanted to refer her to a surgeon,” Dr. Redberg said. And “Medicare would have been happy to pay for it.”
But her mother often has problems with wounds healing, she said, and recovery would likely have taken 3 months. When Dr. Redberg pressed a surgeon about the benefits, he said the procedure could reduce the chances of cancer coming back within 3-5 years.
Dr. Redberg said her mother laughed and said, “I’m not interested in doing something that will help me in 3-5 years. I doubt I’ll be here.”
Finding solutions
The momentum of hospital care can make people feel as if they’re on a moving train and can’t jump off.
The rush of medical decisions “doesn’t allow time to deliberate or consider the patients’ overall health or what their goals and values might be,” said Jacqueline Kruser, MD, an instructor in pulmonary and critical care medicine and medical social sciences at the Northwestern University.
Many hospitals and health systems are developing “decision aids,” easy-to-understand written materials and videos to help patients make more informed medical decisions, giving them time to develop more realistic expectations.
After Kaiser Permanente Washington introduced the tools relating to joint replacement, the number of patients choosing to have hip replacement surgery fell 26%, while knee replacements declined 38%, according to a study in Health Affairs. (Kaiser Permanente is not affiliated with Kaiser Health News, which is an editorially independent program of the Kaiser Family Foundation.)
In a paper published last year in JAMA Surgery and the Journal of Pain and Symptom Management, Dr. Schwarze, Dr. Kruser and colleagues suggested creating narratives to illustrate surgical risks, rather than relying on statistics.
Instead of telling patients that surgery carries a 20% risk of stroke, for example, doctors should lay out the best, worst and most likely outcomes.
In the best-case scenario, a patient might spend weeks in the hospital after surgery, living the rest of her life in a nursing home. In the worst case, the same patient dies after several weeks in intensive care. In the most likely scenario, the patient survives just 2-3 months after surgery.
Dr. Schwarze said, “If someone says they can’t tolerate the best-case scenario – which involves them being in a nursing home – then maybe we shouldn’t be doing this.”
Maxine Stanich was admitted to the hospital after going to the ER because she felt short of breath. She experienced an abnormal heart rhythm in the procedure room during a cardiac test – not an unusual event during a procedure in which a wire is threaded into the heart. Based on that, doctors decided to implant a pacemaker and defibrillator the next day.
Dr. Redberg was consulted when the patient objected to the device that was now embedded in her chest. She was “very alert. She was very clear about what she did and did not want done. She told me she didn’t want to be shocked,” Redberg said.
After Dr. Redberg deactivated the defibrillator, which can be reprogrammed remotely, Stanich was discharged, with home hospice service. With nothing more than her medicines, she survived another 2 years and 3 months, dying at home just after her 90th birthday in 2010.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN’s coverage related to aging and improving care of older adults is supported in part by The John A. Hartford Foundation.
At 87, Maxine Stanich cared more about improving the quality of her life than prolonging it.
She suffered from a long list of health problems, including heart failure and chronic lung disease that could leave her gasping for breath.
When her time came, she wanted to die a natural death, Stanich told her daughter, and signed a “do not resuscitate” directive, or DNR, ordering doctors not to revive her should her heart stop.
Yet a trip to a San Francisco emergency room for shortness of breath in 2008 led Stanich to get a defibrillator implanted in her chest – a medical device to keep her alive by delivering a powerful shock. At the time, Stanich didn’t fully grasp what she had agreed to, even though she signed a document granting permission for the procedure, said her daughter, Susan Giaquinto.
That clarity came only during a subsequent visit to a different hospital, when a surprised ER doctor saw a defibrillator protruding from the DNR patient’s thin chest. To Stanich’s horror, the ER doctor explained that the device would not allow her to slip away painlessly and that the jolt would be “so strong that it will knock her across the room,” said Giaquinto, who accompanied her mother on both hospital trips.
Surgery like this has become all too common among those near the end of life, experts say. Nearly one in three Medicare patients undergo an operation in the year before they die, even though the evidence shows that many are more likely to be harmed than to benefit from it.
The practice is driven by financial incentives that reward doctors for doing procedures, as well as a medical culture in which patients and doctors are reluctant to talk about how surgical interventions should be prescribed more judiciously, said Rita Redberg, M.D., a cardiologist who treated Stanich when she sought care at the second hospital.
“We have a culture that believes in very aggressive care,” said Dr. Redberg, who at the University of California–San Francisco specializes in heart disease in women. “We are often not considering the chance of benefit and chance of harm, and how that changes when you get older. We also fail to have conversations about what patients value most.”
While surgery is typically lifesaving for younger people, operating on frail, older patients rarely helps them live longer or returns the quality of life they once enjoyed, according to a 2016 paper in Annals of Surgery.
The cost of these surgeries – typically paid for by Medicare, the government health insurance program for people over 65 – involve more than money, said Amber Barnato, MD, professor at the Dartmouth Institute for Health Policy and Clinical Practice. Older patients who undergo surgery within a year of death spent 50 percent more time in the hospital than others, and nearly twice as many days in intensive care.
And while some robust octogenarians have many years ahead of them, studies show that surgery is also common among those who are far more frail.
Eighteen percent of Medicare patients have surgery in their final month of life and 8% in their final week, according to a 2011 study in The Lancet.
More than 12% of defibrillators were implanted in people older than 80, according to a 2015 study. Doctors implant about 158,000 of the devices each year, according to the American College of Cardiology. The total cost of the procedure runs about $60,000.
Procedures performed in the elderly range from major operations that require lengthy recoveries to relatively minor surgery performed in a doctor’s office, such as the removal of nonfatal skin cancers, that would likely never cause any problems.
Research led by Eleni Linos, MD, has shown that people with limited life expectancies are treated for nonfatal skin cancers as aggressively as younger patients. Among patients with a nonfatal skin cancer and a limited time to live, 70 percent underwent surgery, according to her 2013 study in JAMA Internal Medicine.
When less is more
Surgery poses serious risks for older people, who weather anesthesia poorly and whose skin takes longer to heal. Among seniors who undergo urgent or emergency abdominal surgery, 20% die within 30 days, studies show.
With diminished mental acuity and an old-fashioned respect for the medical profession, some aging patients are vulnerable to unwanted interventions. Stanich agreed to a pacemaker simply because her doctor suggested it, Giaquinto said. Many people of Stanich’s generation “thought doctors were God … They never questioned doctors – ever.”
Margaret Schwarze, MD, a surgeon and associate professor at the University of Wisconsin, said that older patients often don’t feel the financial pain of surgery because insurance pays most of the cost.
When a surgeon offers to “fix” the heart valve in a person with multiple diseases, for example, the patient may assume that surgery will fix all of her medical problems, Dr. Schwarze said. “With older patients with lots of chronic illnesses, we’re not really fixing anything.”
Even as a doctor, Dr. Redberg said, she struggles to prevent other doctors from performing too many procedures on her 92-year-old mother, Mae, who lives in New York City.
Dr. Redberg said doctors recently treated her mother for melanoma – the most serious type of skin cancer. After the cancer was removed from her leg, Dr. Redberg’s mother was urged by a doctor to undergo an additional surgery to cut away more tissue and nearby lymph nodes, which can harbor cancerous cells.
“Every time she went in, the dermatologist wanted to refer her to a surgeon,” Dr. Redberg said. And “Medicare would have been happy to pay for it.”
But her mother often has problems with wounds healing, she said, and recovery would likely have taken 3 months. When Dr. Redberg pressed a surgeon about the benefits, he said the procedure could reduce the chances of cancer coming back within 3-5 years.
Dr. Redberg said her mother laughed and said, “I’m not interested in doing something that will help me in 3-5 years. I doubt I’ll be here.”
Finding solutions
The momentum of hospital care can make people feel as if they’re on a moving train and can’t jump off.
The rush of medical decisions “doesn’t allow time to deliberate or consider the patients’ overall health or what their goals and values might be,” said Jacqueline Kruser, MD, an instructor in pulmonary and critical care medicine and medical social sciences at the Northwestern University.
Many hospitals and health systems are developing “decision aids,” easy-to-understand written materials and videos to help patients make more informed medical decisions, giving them time to develop more realistic expectations.
After Kaiser Permanente Washington introduced the tools relating to joint replacement, the number of patients choosing to have hip replacement surgery fell 26%, while knee replacements declined 38%, according to a study in Health Affairs. (Kaiser Permanente is not affiliated with Kaiser Health News, which is an editorially independent program of the Kaiser Family Foundation.)
In a paper published last year in JAMA Surgery and the Journal of Pain and Symptom Management, Dr. Schwarze, Dr. Kruser and colleagues suggested creating narratives to illustrate surgical risks, rather than relying on statistics.
Instead of telling patients that surgery carries a 20% risk of stroke, for example, doctors should lay out the best, worst and most likely outcomes.
In the best-case scenario, a patient might spend weeks in the hospital after surgery, living the rest of her life in a nursing home. In the worst case, the same patient dies after several weeks in intensive care. In the most likely scenario, the patient survives just 2-3 months after surgery.
Dr. Schwarze said, “If someone says they can’t tolerate the best-case scenario – which involves them being in a nursing home – then maybe we shouldn’t be doing this.”
Maxine Stanich was admitted to the hospital after going to the ER because she felt short of breath. She experienced an abnormal heart rhythm in the procedure room during a cardiac test – not an unusual event during a procedure in which a wire is threaded into the heart. Based on that, doctors decided to implant a pacemaker and defibrillator the next day.
Dr. Redberg was consulted when the patient objected to the device that was now embedded in her chest. She was “very alert. She was very clear about what she did and did not want done. She told me she didn’t want to be shocked,” Redberg said.
After Dr. Redberg deactivated the defibrillator, which can be reprogrammed remotely, Stanich was discharged, with home hospice service. With nothing more than her medicines, she survived another 2 years and 3 months, dying at home just after her 90th birthday in 2010.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN’s coverage related to aging and improving care of older adults is supported in part by The John A. Hartford Foundation.
Intermittent dosing cuts time to extubation for surgical patients
SAN ANTONIO – according to a preliminary analysis of a randomized trial.
Additionally, the researchers found that much lower amounts of sedation and analgesia were given to patients who underwent intermittent dosing, compared with patients who received a continuous infusion.
Of the 95 patients in the trial, 39 were randomized to intermittent dosing and 56 to the control group of continuous infusion, with the drugs midazolam and fentanyl having been given to both groups.
Mean mechanical ventilation time was 65 hours in the intermittent dosing arm, versus 111 hours in the continuous infusion arm (P less than 0.03), noted Dr. Sich, a fourth-year general surgery resident at Abington Memorial Hospital, Abington, Pa., during his presentation.
Patients in the continuous infusions arm of the trial received a mean of 73.1 mg of midazolam, compared with 18 mg for the intermittent dosing arm, a difference that approached very closely to statistical significance (P = 0.06) and was thrown off in the latest iteration by an outlier, Dr. Sich explained. The relative difference between the mean fentanyl doses administered was even greater between the two groups, with 5,848 mcg given to patients in the control group, versus the 942 mcg given to participants in the intermittent dosing group (P less than 0.01).
“This is a new way to use an old drug, and it really might be beneficial, and can even be used as first-line therapy and a way to keep patients awake and off the ventilator,” said Dr. Sich, referring to the intermittent dosing. Continuous infusions leave patients oversedated and prolong ventilation time.
“What we propose, rather, is using a sliding-scale intermittent pain and sedation regimen,” he said. “We believe that it won’t compromise patient care and won’t compromise patient comfort, and it will lead to shorter mechanical ventilation times for surgical patients than continuous infusions.”
Dr. Sich also pointed out that there was no difference in time spent at target levels of sedation and analgesia between the two trial groups. Referring to this finding, he noted that “we wanted to make sure that in the intermittent arm we’re giving them less drug, but we don’t want them to be [less comfortable].”
One potential drawback to the intermittent dosing approach is that it is more nursing intensive, according to Dr. Sich, since it is based on a nursing treatment protocol to give medications every hour.
Intermittent dosing is “more hands-on” than a typical continuous infusion approach and so was more challenging for nurses who, per the treatment protocol, had to give medications every hour, he explained. However, “when they saw the data in the months and year as we’ve been going on, they’re actually quite proud of our work and their work.”
Gilman Baker Allen, MD, a pulmonologist and intensivist at the University of Vermont Medical Center, Burlington, said the study was “terrific work” and acknowledged the importance of gauging nurse satisfaction with the protocol.
“I think that when you feed this kind of data back to nursing staff, they may not be satisfied with the intensity of the work, but when they see the rewards at the end, it oftentimes is a very positive experience,” said Dr. Allen, who moderated the session.
Dr. Sich and his colleagues had no financial disclosures or conflicts of interest related to the study.
SOURCE: Sich N et al. CCC47, Abstract 18.
SAN ANTONIO – according to a preliminary analysis of a randomized trial.
Additionally, the researchers found that much lower amounts of sedation and analgesia were given to patients who underwent intermittent dosing, compared with patients who received a continuous infusion.
Of the 95 patients in the trial, 39 were randomized to intermittent dosing and 56 to the control group of continuous infusion, with the drugs midazolam and fentanyl having been given to both groups.
Mean mechanical ventilation time was 65 hours in the intermittent dosing arm, versus 111 hours in the continuous infusion arm (P less than 0.03), noted Dr. Sich, a fourth-year general surgery resident at Abington Memorial Hospital, Abington, Pa., during his presentation.
Patients in the continuous infusions arm of the trial received a mean of 73.1 mg of midazolam, compared with 18 mg for the intermittent dosing arm, a difference that approached very closely to statistical significance (P = 0.06) and was thrown off in the latest iteration by an outlier, Dr. Sich explained. The relative difference between the mean fentanyl doses administered was even greater between the two groups, with 5,848 mcg given to patients in the control group, versus the 942 mcg given to participants in the intermittent dosing group (P less than 0.01).
“This is a new way to use an old drug, and it really might be beneficial, and can even be used as first-line therapy and a way to keep patients awake and off the ventilator,” said Dr. Sich, referring to the intermittent dosing. Continuous infusions leave patients oversedated and prolong ventilation time.
“What we propose, rather, is using a sliding-scale intermittent pain and sedation regimen,” he said. “We believe that it won’t compromise patient care and won’t compromise patient comfort, and it will lead to shorter mechanical ventilation times for surgical patients than continuous infusions.”
Dr. Sich also pointed out that there was no difference in time spent at target levels of sedation and analgesia between the two trial groups. Referring to this finding, he noted that “we wanted to make sure that in the intermittent arm we’re giving them less drug, but we don’t want them to be [less comfortable].”
One potential drawback to the intermittent dosing approach is that it is more nursing intensive, according to Dr. Sich, since it is based on a nursing treatment protocol to give medications every hour.
Intermittent dosing is “more hands-on” than a typical continuous infusion approach and so was more challenging for nurses who, per the treatment protocol, had to give medications every hour, he explained. However, “when they saw the data in the months and year as we’ve been going on, they’re actually quite proud of our work and their work.”
Gilman Baker Allen, MD, a pulmonologist and intensivist at the University of Vermont Medical Center, Burlington, said the study was “terrific work” and acknowledged the importance of gauging nurse satisfaction with the protocol.
“I think that when you feed this kind of data back to nursing staff, they may not be satisfied with the intensity of the work, but when they see the rewards at the end, it oftentimes is a very positive experience,” said Dr. Allen, who moderated the session.
Dr. Sich and his colleagues had no financial disclosures or conflicts of interest related to the study.
SOURCE: Sich N et al. CCC47, Abstract 18.
SAN ANTONIO – according to a preliminary analysis of a randomized trial.
Additionally, the researchers found that much lower amounts of sedation and analgesia were given to patients who underwent intermittent dosing, compared with patients who received a continuous infusion.
Of the 95 patients in the trial, 39 were randomized to intermittent dosing and 56 to the control group of continuous infusion, with the drugs midazolam and fentanyl having been given to both groups.
Mean mechanical ventilation time was 65 hours in the intermittent dosing arm, versus 111 hours in the continuous infusion arm (P less than 0.03), noted Dr. Sich, a fourth-year general surgery resident at Abington Memorial Hospital, Abington, Pa., during his presentation.
Patients in the continuous infusions arm of the trial received a mean of 73.1 mg of midazolam, compared with 18 mg for the intermittent dosing arm, a difference that approached very closely to statistical significance (P = 0.06) and was thrown off in the latest iteration by an outlier, Dr. Sich explained. The relative difference between the mean fentanyl doses administered was even greater between the two groups, with 5,848 mcg given to patients in the control group, versus the 942 mcg given to participants in the intermittent dosing group (P less than 0.01).
“This is a new way to use an old drug, and it really might be beneficial, and can even be used as first-line therapy and a way to keep patients awake and off the ventilator,” said Dr. Sich, referring to the intermittent dosing. Continuous infusions leave patients oversedated and prolong ventilation time.
“What we propose, rather, is using a sliding-scale intermittent pain and sedation regimen,” he said. “We believe that it won’t compromise patient care and won’t compromise patient comfort, and it will lead to shorter mechanical ventilation times for surgical patients than continuous infusions.”
Dr. Sich also pointed out that there was no difference in time spent at target levels of sedation and analgesia between the two trial groups. Referring to this finding, he noted that “we wanted to make sure that in the intermittent arm we’re giving them less drug, but we don’t want them to be [less comfortable].”
One potential drawback to the intermittent dosing approach is that it is more nursing intensive, according to Dr. Sich, since it is based on a nursing treatment protocol to give medications every hour.
Intermittent dosing is “more hands-on” than a typical continuous infusion approach and so was more challenging for nurses who, per the treatment protocol, had to give medications every hour, he explained. However, “when they saw the data in the months and year as we’ve been going on, they’re actually quite proud of our work and their work.”
Gilman Baker Allen, MD, a pulmonologist and intensivist at the University of Vermont Medical Center, Burlington, said the study was “terrific work” and acknowledged the importance of gauging nurse satisfaction with the protocol.
“I think that when you feed this kind of data back to nursing staff, they may not be satisfied with the intensity of the work, but when they see the rewards at the end, it oftentimes is a very positive experience,” said Dr. Allen, who moderated the session.
Dr. Sich and his colleagues had no financial disclosures or conflicts of interest related to the study.
SOURCE: Sich N et al. CCC47, Abstract 18.
Reporting from CCC47
Key clinical point: Among patients requiring ventilation, intermittent administration of sedation and analgesia significantly reduced mechanical ventilation time and total amount of drugs versus a continuous infusion approach.
Major finding: Mean mechanical ventilation time was 65 hours in the intermittent dosing arm, versus 111 hours in the continuous infusion arm (P less than 0.03).
Data source: A single-blinded, randomized, controlled trial of 95 surgical patients requiring ventilation.
Disclosures: The authors reported no financial disclosures or conflicts of interest related to the study.
Source: Sich N et al. CCC47, Abstract 18.
Gender affirmation surgery has become more common
, and private insurers and Medicare and Medicaid are covering more of them, according to a review of the National Inpatient Sample from 2000 to 2014.
“As coverage for these procedures increases, likely so will demand for qualified surgeons to perform them,” said investigators led by Joseph Canner, MHS, of Johns Hopkins University, Baltimore (JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6231).
The team sought to correct a glaring lack of demographic, hospital, and surgical data on transgender people, a problem due mainly to “the absence of routine, standardized collection and reporting of gender identity in health care settings,” the investigators said.
The Affordable Care Act banned gender identity discrimination, and state and federal governments – as well as private insurers – are expanding coverage of gender affirmation surgery and care. Given the trend, it’s essential that quality improvement agencies begin to “focus on adopting a new set of patient-centered measures to better monitor transgender care and identify opportunities for advancing transition-related services,” the researchers said.
The team identified 37,827 hospital encounters in the national database that had ICD-9 diagnosis codes of transsexualism or gender identity disorder that were listed in the National Inpatient Sample. The rate of those codes increased from 3.87/100,000 patients in 2000 to 14.22 /100,000 patients in 2014.
Mental health was the leading cause of hospitalization, accounting for 40.5% of admissions, a finding that “is consistent with the high prevalence of depression, anxiety, and suicidal ideation in this population,” the investigators said.
Patients were a median age of 38 years old; 57.1% identified as white; and 54.3% were categorized as male, 38.3% as female, and most of the rest as “inconsistent,” meaning their sex in the medical record did not match their procedures.
Almost 11% were hospitalized for gender affirmation surgery, including penile or vaginal construction. From 2000 to 2005, 72% of patients who underwent affirmation procedures had genital surgery; the number increased to 83.9% from 2006 to 2011. More than half of the patients weren’t covered by insurance, but the number covered by Medicare or Medicaid increased from 25 patients in 2012-2013 to 70 in 2014. Meanwhile, no one died in the hospital from gender reassignment surgery, and the median stay was 4 days.
“Our data suggest that genital surgery is the most common type of inpatient gender-affirming surgery; however, these data do not include gender-affirming surgical procedures performed in outpatient settings, which likely include most chest, breast, and facial surgery,” the investigators wrote.
Surgery patients in high-volume centers (performing more than 50 gender-affirming procedures per year) were mostly self-pay, while those admitted to low-volume centers were not. “It is possible that self-paying patients may be getting higher-quality care at high-volume centers, as has been observed in other types of surgery,” according to the investigators. There is a need for national clinical and patient-reported outcomes data to assess and improve the quality of gender-affirming surgery. Gender identity information should be a part of all electronic health records and reported back to national data repositories, they said.
The investigators are supported by the Patient-Centered Outcomes Research Institute, the Agency for Healthcare Research and Quality, and the National Institutes of Health, among others. They had no industry disclosures.
SOURCE: Canner JK et al. JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6231.
The study is thought provoking and suggests many areas for future study.
Gender-affirming surgery is the final step in a spectrum of treatments for gender identity disorders or transsexualism, including psychological counseling, hormonal therapies, and pubertal hormone blockers. Referrals for these treatments are increasing, and likely the demand for surgical treatment will also continue to increase.
A comprehensive database or other prospective tool to assess the comparative efficacy of these treatments, create quality metrics, and address long-term health or psychiatric outcomes should be pursued.
Future research must address cost effectiveness and cost burdens, given increased public funding for gender affirmation surgeries. Most longitudinal studies of patients who have undergone gender affirmation procedures have found high satisfaction rates with low rates of regret (less than 5%). However, when regret occurs, it can be surgically challenging and costly to reverse these procedures.
Marie Crandall , MD, is a professor of surgery at the University of Florida, Jacksonville. She made her comments in an editorial and had no industry disclosures (JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6232).
The study is thought provoking and suggests many areas for future study.
Gender-affirming surgery is the final step in a spectrum of treatments for gender identity disorders or transsexualism, including psychological counseling, hormonal therapies, and pubertal hormone blockers. Referrals for these treatments are increasing, and likely the demand for surgical treatment will also continue to increase.
A comprehensive database or other prospective tool to assess the comparative efficacy of these treatments, create quality metrics, and address long-term health or psychiatric outcomes should be pursued.
Future research must address cost effectiveness and cost burdens, given increased public funding for gender affirmation surgeries. Most longitudinal studies of patients who have undergone gender affirmation procedures have found high satisfaction rates with low rates of regret (less than 5%). However, when regret occurs, it can be surgically challenging and costly to reverse these procedures.
Marie Crandall , MD, is a professor of surgery at the University of Florida, Jacksonville. She made her comments in an editorial and had no industry disclosures (JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6232).
The study is thought provoking and suggests many areas for future study.
Gender-affirming surgery is the final step in a spectrum of treatments for gender identity disorders or transsexualism, including psychological counseling, hormonal therapies, and pubertal hormone blockers. Referrals for these treatments are increasing, and likely the demand for surgical treatment will also continue to increase.
A comprehensive database or other prospective tool to assess the comparative efficacy of these treatments, create quality metrics, and address long-term health or psychiatric outcomes should be pursued.
Future research must address cost effectiveness and cost burdens, given increased public funding for gender affirmation surgeries. Most longitudinal studies of patients who have undergone gender affirmation procedures have found high satisfaction rates with low rates of regret (less than 5%). However, when regret occurs, it can be surgically challenging and costly to reverse these procedures.
Marie Crandall , MD, is a professor of surgery at the University of Florida, Jacksonville. She made her comments in an editorial and had no industry disclosures (JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6232).
, and private insurers and Medicare and Medicaid are covering more of them, according to a review of the National Inpatient Sample from 2000 to 2014.
“As coverage for these procedures increases, likely so will demand for qualified surgeons to perform them,” said investigators led by Joseph Canner, MHS, of Johns Hopkins University, Baltimore (JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6231).
The team sought to correct a glaring lack of demographic, hospital, and surgical data on transgender people, a problem due mainly to “the absence of routine, standardized collection and reporting of gender identity in health care settings,” the investigators said.
The Affordable Care Act banned gender identity discrimination, and state and federal governments – as well as private insurers – are expanding coverage of gender affirmation surgery and care. Given the trend, it’s essential that quality improvement agencies begin to “focus on adopting a new set of patient-centered measures to better monitor transgender care and identify opportunities for advancing transition-related services,” the researchers said.
The team identified 37,827 hospital encounters in the national database that had ICD-9 diagnosis codes of transsexualism or gender identity disorder that were listed in the National Inpatient Sample. The rate of those codes increased from 3.87/100,000 patients in 2000 to 14.22 /100,000 patients in 2014.
Mental health was the leading cause of hospitalization, accounting for 40.5% of admissions, a finding that “is consistent with the high prevalence of depression, anxiety, and suicidal ideation in this population,” the investigators said.
Patients were a median age of 38 years old; 57.1% identified as white; and 54.3% were categorized as male, 38.3% as female, and most of the rest as “inconsistent,” meaning their sex in the medical record did not match their procedures.
Almost 11% were hospitalized for gender affirmation surgery, including penile or vaginal construction. From 2000 to 2005, 72% of patients who underwent affirmation procedures had genital surgery; the number increased to 83.9% from 2006 to 2011. More than half of the patients weren’t covered by insurance, but the number covered by Medicare or Medicaid increased from 25 patients in 2012-2013 to 70 in 2014. Meanwhile, no one died in the hospital from gender reassignment surgery, and the median stay was 4 days.
“Our data suggest that genital surgery is the most common type of inpatient gender-affirming surgery; however, these data do not include gender-affirming surgical procedures performed in outpatient settings, which likely include most chest, breast, and facial surgery,” the investigators wrote.
Surgery patients in high-volume centers (performing more than 50 gender-affirming procedures per year) were mostly self-pay, while those admitted to low-volume centers were not. “It is possible that self-paying patients may be getting higher-quality care at high-volume centers, as has been observed in other types of surgery,” according to the investigators. There is a need for national clinical and patient-reported outcomes data to assess and improve the quality of gender-affirming surgery. Gender identity information should be a part of all electronic health records and reported back to national data repositories, they said.
The investigators are supported by the Patient-Centered Outcomes Research Institute, the Agency for Healthcare Research and Quality, and the National Institutes of Health, among others. They had no industry disclosures.
SOURCE: Canner JK et al. JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6231.
, and private insurers and Medicare and Medicaid are covering more of them, according to a review of the National Inpatient Sample from 2000 to 2014.
“As coverage for these procedures increases, likely so will demand for qualified surgeons to perform them,” said investigators led by Joseph Canner, MHS, of Johns Hopkins University, Baltimore (JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6231).
The team sought to correct a glaring lack of demographic, hospital, and surgical data on transgender people, a problem due mainly to “the absence of routine, standardized collection and reporting of gender identity in health care settings,” the investigators said.
The Affordable Care Act banned gender identity discrimination, and state and federal governments – as well as private insurers – are expanding coverage of gender affirmation surgery and care. Given the trend, it’s essential that quality improvement agencies begin to “focus on adopting a new set of patient-centered measures to better monitor transgender care and identify opportunities for advancing transition-related services,” the researchers said.
The team identified 37,827 hospital encounters in the national database that had ICD-9 diagnosis codes of transsexualism or gender identity disorder that were listed in the National Inpatient Sample. The rate of those codes increased from 3.87/100,000 patients in 2000 to 14.22 /100,000 patients in 2014.
Mental health was the leading cause of hospitalization, accounting for 40.5% of admissions, a finding that “is consistent with the high prevalence of depression, anxiety, and suicidal ideation in this population,” the investigators said.
Patients were a median age of 38 years old; 57.1% identified as white; and 54.3% were categorized as male, 38.3% as female, and most of the rest as “inconsistent,” meaning their sex in the medical record did not match their procedures.
Almost 11% were hospitalized for gender affirmation surgery, including penile or vaginal construction. From 2000 to 2005, 72% of patients who underwent affirmation procedures had genital surgery; the number increased to 83.9% from 2006 to 2011. More than half of the patients weren’t covered by insurance, but the number covered by Medicare or Medicaid increased from 25 patients in 2012-2013 to 70 in 2014. Meanwhile, no one died in the hospital from gender reassignment surgery, and the median stay was 4 days.
“Our data suggest that genital surgery is the most common type of inpatient gender-affirming surgery; however, these data do not include gender-affirming surgical procedures performed in outpatient settings, which likely include most chest, breast, and facial surgery,” the investigators wrote.
Surgery patients in high-volume centers (performing more than 50 gender-affirming procedures per year) were mostly self-pay, while those admitted to low-volume centers were not. “It is possible that self-paying patients may be getting higher-quality care at high-volume centers, as has been observed in other types of surgery,” according to the investigators. There is a need for national clinical and patient-reported outcomes data to assess and improve the quality of gender-affirming surgery. Gender identity information should be a part of all electronic health records and reported back to national data repositories, they said.
The investigators are supported by the Patient-Centered Outcomes Research Institute, the Agency for Healthcare Research and Quality, and the National Institutes of Health, among others. They had no industry disclosures.
SOURCE: Canner JK et al. JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6231.
FROM JAMA SURGERY
Key clinical point: With gender affirmation surgeries on the rise in the United States, it’s time for a more rigorous system to track outcomes.
Major finding: The rate of transsexual and gender identity disorder codes in the National Inpatient Sample increased from 3.87/100,000 patients in 2000 to 14.22/100,000 patients in 2014.
Study details: A review of 37,827 hospital encounters reported in the National Inpatient Sample.
Disclosures: The investigators are supported by the Patient-Centered Outcomes Research Institute, the Agency for Healthcare Research and Quality, and the National Institutes of Health, among others. They had no industry disclosures.
Source: Canner JK et al. JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6231.
Guidelines update best practices for hemorrhoid treatment
Each year, more than 2.2 million patients in the United States undergo evaluations for symptoms of hemorrhoids, according to updated guidelines on the management of hemorrhoids issued by the American Society of Colon and Rectal Surgeons.
“As a result, it is important to identify symptomatic hemorrhoids as the underlying source of the anorectal symptom and to have a clear understanding of the evaluation and management of this disease process,” wrote Bradley R. Davis, MD, FACS, chief of colon and rectal surgery at the Carolinas Medical Center, Charlotte, N.C., and the fellow members of the Clinical Practice Guidelines Committee of the ASCRS.
The guidelines recommend evaluation of hemorrhoids based on a disease-specific history, and a physical that emphasizes the degree and duration of symptoms and identifies risk factors. But the guideline writers note that the recommendation is a grade 1C because the supporting data mainly come from observational or case studies.
“The cardinal signs of internal hemorrhoids are painless bleeding with bowel movements with intermittent protrusion,” the committee said, also emphasizing that patients should be evaluated for fecal incontinence, which could inform surgical decision making.
In addition, the guidelines call for a complete endoscopic evaluation of the colon for patients who present with symptomatic hemorrhoids and rectal bleeding; this recommendation is based on moderately strong evidence, and presented with a grade of 1B.
Medical management of hemorrhoids may include office-based procedures or surgery, according to the guidelines.
“Most patients with grade I and II and select patients with grade III internal hemorrhoidal disease who fail medical treatment can be effectively treated with office-based procedures, such as banding, sclerotherapy, and infrared coagulation,” the committee wrote, and medical office treatment received a strong grade 1A recommendation based on high-quality evidence. Although office procedures are generally well tolerated, the condition can recur. Bleeding is the most common complication, and it is more likely after rubber-band ligation than other office-based options, the guidelines state.
The guidelines offer a weak recommendation of 2C, based on the lack of quality evidence, for the use of early surgical excision to treat patients with thrombosed external hemorrhoids. “Although most patients treated nonoperatively will experience eventual resolution of their symptoms, excision of thrombosed external hemorrhoids may result in more rapid symptom resolution, lower incidence of recurrence, and longer remission intervals,” the committee noted.
Surgical hemorrhoidectomy received the strongest possible recommendation (1A, based on high-quality evidence) for the treatment of patients with external hemorrhoids or a combination of internal and external hemorrhoids with prolapse.
Surgical options described in the recommendations include surgical excision (hemorrhoidectomy), hemorrhoidopexy, and Doppler-guided hemorrhoidectomy, with citations of studies on each procedure. Data from a meta-analysis of 18 randomized prospective studies comparing hemorrhoidectomy with office-based procedures showed that hemorrhoidectomy was “the most effective treatment for patients with grade III hemorrhoids,” but it was associated with greater pain and complication rates, according to the guidelines.
However, complications in general are low after surgical hemorrhoidectomy, with reported complication rates of 1%-2% for the most common complication of postprocedure hemorrhage, the guidelines state. After surgery, the guidelines recommend with a 1B grade (moderate quality evidence) that patients use “a multimodality pain regimen to reduce narcotic usage and promote a faster recovery.”
The committee members had no financial conflicts to disclose.
acssurgerynews@frontlinemedcom.com
SOURCE: Davis BR et al. Dis Colon Rectum. 2018; 61:284-92.
Each year, more than 2.2 million patients in the United States undergo evaluations for symptoms of hemorrhoids, according to updated guidelines on the management of hemorrhoids issued by the American Society of Colon and Rectal Surgeons.
“As a result, it is important to identify symptomatic hemorrhoids as the underlying source of the anorectal symptom and to have a clear understanding of the evaluation and management of this disease process,” wrote Bradley R. Davis, MD, FACS, chief of colon and rectal surgery at the Carolinas Medical Center, Charlotte, N.C., and the fellow members of the Clinical Practice Guidelines Committee of the ASCRS.
The guidelines recommend evaluation of hemorrhoids based on a disease-specific history, and a physical that emphasizes the degree and duration of symptoms and identifies risk factors. But the guideline writers note that the recommendation is a grade 1C because the supporting data mainly come from observational or case studies.
“The cardinal signs of internal hemorrhoids are painless bleeding with bowel movements with intermittent protrusion,” the committee said, also emphasizing that patients should be evaluated for fecal incontinence, which could inform surgical decision making.
In addition, the guidelines call for a complete endoscopic evaluation of the colon for patients who present with symptomatic hemorrhoids and rectal bleeding; this recommendation is based on moderately strong evidence, and presented with a grade of 1B.
Medical management of hemorrhoids may include office-based procedures or surgery, according to the guidelines.
“Most patients with grade I and II and select patients with grade III internal hemorrhoidal disease who fail medical treatment can be effectively treated with office-based procedures, such as banding, sclerotherapy, and infrared coagulation,” the committee wrote, and medical office treatment received a strong grade 1A recommendation based on high-quality evidence. Although office procedures are generally well tolerated, the condition can recur. Bleeding is the most common complication, and it is more likely after rubber-band ligation than other office-based options, the guidelines state.
The guidelines offer a weak recommendation of 2C, based on the lack of quality evidence, for the use of early surgical excision to treat patients with thrombosed external hemorrhoids. “Although most patients treated nonoperatively will experience eventual resolution of their symptoms, excision of thrombosed external hemorrhoids may result in more rapid symptom resolution, lower incidence of recurrence, and longer remission intervals,” the committee noted.
Surgical hemorrhoidectomy received the strongest possible recommendation (1A, based on high-quality evidence) for the treatment of patients with external hemorrhoids or a combination of internal and external hemorrhoids with prolapse.
Surgical options described in the recommendations include surgical excision (hemorrhoidectomy), hemorrhoidopexy, and Doppler-guided hemorrhoidectomy, with citations of studies on each procedure. Data from a meta-analysis of 18 randomized prospective studies comparing hemorrhoidectomy with office-based procedures showed that hemorrhoidectomy was “the most effective treatment for patients with grade III hemorrhoids,” but it was associated with greater pain and complication rates, according to the guidelines.
However, complications in general are low after surgical hemorrhoidectomy, with reported complication rates of 1%-2% for the most common complication of postprocedure hemorrhage, the guidelines state. After surgery, the guidelines recommend with a 1B grade (moderate quality evidence) that patients use “a multimodality pain regimen to reduce narcotic usage and promote a faster recovery.”
The committee members had no financial conflicts to disclose.
acssurgerynews@frontlinemedcom.com
SOURCE: Davis BR et al. Dis Colon Rectum. 2018; 61:284-92.
Each year, more than 2.2 million patients in the United States undergo evaluations for symptoms of hemorrhoids, according to updated guidelines on the management of hemorrhoids issued by the American Society of Colon and Rectal Surgeons.
“As a result, it is important to identify symptomatic hemorrhoids as the underlying source of the anorectal symptom and to have a clear understanding of the evaluation and management of this disease process,” wrote Bradley R. Davis, MD, FACS, chief of colon and rectal surgery at the Carolinas Medical Center, Charlotte, N.C., and the fellow members of the Clinical Practice Guidelines Committee of the ASCRS.
The guidelines recommend evaluation of hemorrhoids based on a disease-specific history, and a physical that emphasizes the degree and duration of symptoms and identifies risk factors. But the guideline writers note that the recommendation is a grade 1C because the supporting data mainly come from observational or case studies.
“The cardinal signs of internal hemorrhoids are painless bleeding with bowel movements with intermittent protrusion,” the committee said, also emphasizing that patients should be evaluated for fecal incontinence, which could inform surgical decision making.
In addition, the guidelines call for a complete endoscopic evaluation of the colon for patients who present with symptomatic hemorrhoids and rectal bleeding; this recommendation is based on moderately strong evidence, and presented with a grade of 1B.
Medical management of hemorrhoids may include office-based procedures or surgery, according to the guidelines.
“Most patients with grade I and II and select patients with grade III internal hemorrhoidal disease who fail medical treatment can be effectively treated with office-based procedures, such as banding, sclerotherapy, and infrared coagulation,” the committee wrote, and medical office treatment received a strong grade 1A recommendation based on high-quality evidence. Although office procedures are generally well tolerated, the condition can recur. Bleeding is the most common complication, and it is more likely after rubber-band ligation than other office-based options, the guidelines state.
The guidelines offer a weak recommendation of 2C, based on the lack of quality evidence, for the use of early surgical excision to treat patients with thrombosed external hemorrhoids. “Although most patients treated nonoperatively will experience eventual resolution of their symptoms, excision of thrombosed external hemorrhoids may result in more rapid symptom resolution, lower incidence of recurrence, and longer remission intervals,” the committee noted.
Surgical hemorrhoidectomy received the strongest possible recommendation (1A, based on high-quality evidence) for the treatment of patients with external hemorrhoids or a combination of internal and external hemorrhoids with prolapse.
Surgical options described in the recommendations include surgical excision (hemorrhoidectomy), hemorrhoidopexy, and Doppler-guided hemorrhoidectomy, with citations of studies on each procedure. Data from a meta-analysis of 18 randomized prospective studies comparing hemorrhoidectomy with office-based procedures showed that hemorrhoidectomy was “the most effective treatment for patients with grade III hemorrhoids,” but it was associated with greater pain and complication rates, according to the guidelines.
However, complications in general are low after surgical hemorrhoidectomy, with reported complication rates of 1%-2% for the most common complication of postprocedure hemorrhage, the guidelines state. After surgery, the guidelines recommend with a 1B grade (moderate quality evidence) that patients use “a multimodality pain regimen to reduce narcotic usage and promote a faster recovery.”
The committee members had no financial conflicts to disclose.
acssurgerynews@frontlinemedcom.com
SOURCE: Davis BR et al. Dis Colon Rectum. 2018; 61:284-92.
FROM DISEASES OF THE COLON & RECTUM