HYPOTHESIS: The use of staple-line reinforcement sleeves during laparoscopic gastric bypass reduces staple-line bleeding, which may translate into a reduction in the rate of gastrointestinal hemorrhage. DESIGN: Prospective randomized trial. SETTING:University hospital. PATIENTS AND INTERVENTIONS:Thirty-four patients undergoing laparoscopic gastric bypass were randomly assigned to receive either no reinforcement (control group, n = 17) or reinforcement of the staple line with glycolic copolymer sleeves (treatment group, n = 17). MAIN OUTCOME MEASURES: Demographic data, the number of stapler loads used, the number of staple-line bleeding sites, the amount of blood loss, the length of time required to obtain hemostasis of the staple lines, operative time, intraoperative and postoperative complications, and serial hemoglobin levels. RESULTS: The mean number of stapler loads used was similar between groups. The mean number of staple-line bleeding sites was significantly fewer in the treatment group for division of gastric tissue (0.4 vs 2.5 bleeding sites), jejunal tissue (0.1 vs 0.6 bleeding site), and mesenteric tissue (0 vs 0.8 bleeding site). The mean blood loss was lower in the treatment group (84 vs 129 mL). Staple misfire occurred in 1 (0.7%) of 143 stapler loads used in the treatment group compared with 0 (0%) of 138 stapler loads used in the control group. The time to obtain staple-line hemostasis was shorter in the treatment group (1.2 vs 10.1 minutes). The total operative time was similar between groups. There was no mortality or postoperative leaks. One patient in the control group had postoperative gastrointestinal hemorrhage requiring blood transfusion and reoperation. There was no significant difference in the mean hemoglobin level between groups on the first postoperative day. CONCLUSIONS: The use of glycolide copolymer staple-line reinforcement sleeves in patients undergoing laparoscopic gastric bypass is safe and significantly reduces staple-line bleeding sites and may reduce the incidence of gastrointestinal hemorrhage.
RCT Entities:
HYPOTHESIS: The use of staple-line reinforcement sleeves during laparoscopic gastric bypass reduces staple-line bleeding, which may translate into a reduction in the rate of gastrointestinal hemorrhage. DESIGN: Prospective randomized trial. SETTING: University hospital. PATIENTS AND INTERVENTIONS: Thirty-four patients undergoing laparoscopic gastric bypass were randomly assigned to receive either no reinforcement (control group, n = 17) or reinforcement of the staple line with glycolic copolymer sleeves (treatment group, n = 17). MAIN OUTCOME MEASURES: Demographic data, the number of stapler loads used, the number of staple-line bleeding sites, the amount of blood loss, the length of time required to obtain hemostasis of the staple lines, operative time, intraoperative and postoperative complications, and serial hemoglobin levels. RESULTS: The mean number of stapler loads used was similar between groups. The mean number of staple-line bleeding sites was significantly fewer in the treatment group for division of gastric tissue (0.4 vs 2.5 bleeding sites), jejunal tissue (0.1 vs 0.6 bleeding site), and mesenteric tissue (0 vs 0.8 bleeding site). The mean blood loss was lower in the treatment group (84 vs 129 mL). Staple misfire occurred in 1 (0.7%) of 143 stapler loads used in the treatment group compared with 0 (0%) of 138 stapler loads used in the control group. The time to obtain staple-line hemostasis was shorter in the treatment group (1.2 vs 10.1 minutes). The total operative time was similar between groups. There was no mortality or postoperative leaks. One patient in the control group had postoperative gastrointestinal hemorrhage requiring blood transfusion and reoperation. There was no significant difference in the mean hemoglobin level between groups on the first postoperative day. CONCLUSIONS: The use of glycolide copolymer staple-line reinforcement sleeves in patients undergoing laparoscopic gastric bypass is safe and significantly reduces staple-line bleeding sites and may reduce the incidence of gastrointestinal hemorrhage.
Authors: Joshua B Alley; Stephen J Fenton; Michael C Harnisch; Michael N Angeletti; Richard M Peterson Journal: Obes Surg Date: 2011-08 Impact factor: 4.129