INTRODUCTION: A temporary loop ileostomy is often created to minimize the impact of peritoneal sepsis from an anastomotic dehiscence after a coloanal or low colorectal anastomosis. Such a stoma is usually closed after 6 to 12 weeks when the intestinal edema is reduced and the peristomal adhesions are less dense. This period is three to four times longer than necessary for assurance of anastomotic healing, which is usually achieved by the second week after surgery. With the use of a bioresorbable membrane to minimize the formation of peristomal adhesions, earlier closure is hypothetically possible at three weeks. METHODS:Patients undergoing creation of a defunctioning ileostomy were randomized in Phase I either to have an adhesion barrier membrane wrapped around the limbs of the ileostomy, with closure at three weeks, or to the control group, with no barrier membrane and closure after more than six weeks. In the subsequent Phase II, the efficacy of the barrier membrane was compared in a similar manner with a control group at ileostomy reversal after three weeks. Peristomal adhesions at the time of stomal mobilization were scored in a blinded manner. RESULTS: In Phase I, no statistically significant differences were noted in the mean adhesion scores between the two groups (7.42 vs. 7.28). However, in Phase II, when peristomal adhesions at closure were compared at three weeks for both groups, with and without adhesion barrier placement, there was a significant reduction in the overall mean adhesion scores (5.81 vs. 7.82, respectively). The number of patients with dense adhesions was also reduced in the adhesion barrier group. There was no significant difference in the time taken and the difficulty encountered during ileostomy closure in the two groups. A tendency to easier closure, as evidenced by a lower incidence of perioperative complications, was noted in the adhesion barrier group. CONCLUSION: An adhesion barrier membrane placed around the limbs of a defunctioning loop ileostomy reduces peristomal adhesion and facilitates early closure at three weeks with minimal complications.
RCT Entities:
INTRODUCTION: A temporary loop ileostomy is often created to minimize the impact of peritoneal sepsis from an anastomotic dehiscence after a coloanal or low colorectal anastomosis. Such a stoma is usually closed after 6 to 12 weeks when the intestinal edema is reduced and the peristomal adhesions are less dense. This period is three to four times longer than necessary for assurance of anastomotic healing, which is usually achieved by the second week after surgery. With the use of a bioresorbable membrane to minimize the formation of peristomal adhesions, earlier closure is hypothetically possible at three weeks. METHODS:Patients undergoing creation of a defunctioning ileostomy were randomized in Phase I either to have an adhesion barrier membrane wrapped around the limbs of the ileostomy, with closure at three weeks, or to the control group, with no barrier membrane and closure after more than six weeks. In the subsequent Phase II, the efficacy of the barrier membrane was compared in a similar manner with a control group at ileostomy reversal after three weeks. Peristomal adhesions at the time of stomal mobilization were scored in a blinded manner. RESULTS: In Phase I, no statistically significant differences were noted in the mean adhesion scores between the two groups (7.42 vs. 7.28). However, in Phase II, when peristomal adhesions at closure were compared at three weeks for both groups, with and without adhesion barrier placement, there was a significant reduction in the overall mean adhesion scores (5.81 vs. 7.82, respectively). The number of patients with dense adhesions was also reduced in the adhesion barrier group. There was no significant difference in the time taken and the difficulty encountered during ileostomy closure in the two groups. A tendency to easier closure, as evidenced by a lower incidence of perioperative complications, was noted in the adhesion barrier group. CONCLUSION: An adhesion barrier membrane placed around the limbs of a defunctioning loop ileostomy reduces peristomal adhesion and facilitates early closure at three weeks with minimal complications.
Authors: Danielle M Bertoni; Kerry L Hammond; David E Beck; Terry C Hicks; Charles B Whitlow; H David Vargas; David A Margolin Journal: Ochsner J Date: 2017