A prospective, randomized, multicenter trial of Surgisis Gold, a biologic prosthetic, as a sublay reinforcement of the fascial closure after open bariatric surgery.

PURPOSE: This prospective, multicenter, randomized clinical trial was performed to compare the effectiveness of the bioprosthesis Surgisis Gold (Cook Biotech, Inc, West Lafayette, IN) to suture closure alone in reinforcing the abdominal wall after open Roux-en-Y gastric bypass (RYGB).
METHODS: A total of 402 adult patients (body mass index ≥35 kg/m(2)) scheduled to undergo open RYGB procedures were randomized to receive either Surgisis Gold placed as a sublay directly under and opposed to the posterior rectus fascia without intervening preperitoneal fat or suture closure alone. Peri- and postoperative complications were tracked. Incisional hernia formation in each group was examined at 6 weeks, 3, 6, and 9 months, and 1 and 2 years after RYGB.
RESULTS: A total of 380 (78 male; 302 female) patients with a mean age of 45 years (range 18-69) and a mean BMI of 48 (range 35-79) underwent RYGB. There were no differences in patient demographics or comorbidities between groups. Placement of the Surgisis Gold increased operating time by an average of 14 minutes. Complications were more common in the Surgisis Gold group with significantly more wound events and seroma formation compared with the suture closure alone group. At final follow-up, 32 of 185 (17%) of patients in the reinforced arm and 38 of 195 (20%) in the suture alone arm developed an incisional hernia (P = .6).
CONCLUSION: In this challenging patient population, the use of Surgisis Gold for reinforcing the abdominal wall after open RYGB was not shown to be greatly different from a primary suture repair.

RCT Entities:   Population Interventions Outcomes