BACKGROUND:Postoperative anastomotic leaks, bleeding and stenosis are major causes of morbidity after laparoscopic Roux-en-Y gastric bypass (LRYGB). Retrospective studies suggest that intraoperative endoscopy reduces the incidence of these complications. METHODS: We conducted a prospective randomized controlled trial in a single institution between March 2013 and January 2016. Patients were assigned to one of two groups: LRYGB with Intraoperative Endoscopy (IOE) or LRYGB without IOE. Patient selection criteria were morbidly obese patients, 18 years or older who were candidates to LRYGB. The primary outcome was the frequency of technical defect related anastomotic leaks. Secondary outcomes were operative time, length of hospital stay, anastomotic related complications, reoperations and 30-day mortality. RESULTS:50 patients were randomly assigned in the IOE group and 50 in the control group. The IOE group had statistically significant lower rate of anastomotic leak (0 vs. 8%, p = .0412), and lower need for reoperation (0 vs. 8%, p = .0412). The IOE group had longer operative time (194.10 vs. 159 min, p < .001), and shorter mean length of hospital stay (2.44 vs. 3.46 days, p = .025). No differences were found in the rate of bleeding of the anastomosis, narrow anastomosis and 30-day mortality. CONCLUSION: This study specifically provides evidence that air leak test performed by intraoperative endoscopy is superior to simple visual inspection in preventing technical defect related leaks after laparoscopic Roux-en-Y gastric bypass.
RCT Entities:
BACKGROUND:Postoperative anastomotic leaks, bleeding and stenosis are major causes of morbidity after laparoscopic Roux-en-Y gastric bypass (LRYGB). Retrospective studies suggest that intraoperative endoscopy reduces the incidence of these complications. METHODS: We conducted a prospective randomized controlled trial in a single institution between March 2013 and January 2016. Patients were assigned to one of two groups: LRYGB with Intraoperative Endoscopy (IOE) or LRYGB without IOE. Patient selection criteria were morbidly obesepatients, 18 years or older who were candidates to LRYGB. The primary outcome was the frequency of technical defect related anastomotic leaks. Secondary outcomes were operative time, length of hospital stay, anastomotic related complications, reoperations and 30-day mortality. RESULTS: 50 patients were randomly assigned in the IOE group and 50 in the control group. The IOE group had statistically significant lower rate of anastomotic leak (0 vs. 8%, p = .0412), and lower need for reoperation (0 vs. 8%, p = .0412). The IOE group had longer operative time (194.10 vs. 159 min, p < .001), and shorter mean length of hospital stay (2.44 vs. 3.46 days, p = .025). No differences were found in the rate of bleeding of the anastomosis, narrow anastomosis and 30-day mortality. CONCLUSION: This study specifically provides evidence that air leak test performed by intraoperative endoscopy is superior to simple visual inspection in preventing technical defect related leaks after laparoscopic Roux-en-Y gastric bypass.