Elsevier

Surgery

Volume 156, Issue 4, October 2014, Pages 902-909
Surgery

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

Presented at the annual Central Surgical Association in Indianapolis, IN, on March 9, 2014.
https://doi.org/10.1016/j.surg.2014.06.022Get rights and content

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/m2) 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.

Section snippets

Methods

This industry-funded study (Cook Biotech, Inc) was designed as a multicenter, prospective, randomized trial in patients undergoing open Roux-en-Y gastric bypass (RYGB) at two medical centers: Virginia Commonwealth Surgeons, Richmond, Virginia, and Mayo Clinic, Rochester, Minnesota. This study was approved by the Institutional Review Boards of the two participating medical centers and registered at www.ClinicalTrials.gov as NCT00274625. Informed consent to participate was obtained from all

Results

A total of 402 patients were enrolled in this study and comprised the intention-to-treat population across the two participating sites (Fig 2). Of these 402 patients, 199 were randomized to the Surgisis Gold arm, 14 of whom were eventually excluded; 203 were randomized to the suture arm, 8 of whom were excluded. Patients were excluded either intraoperatively at the time of skin incision and exposure of the fascia because they did not meet the inclusion criteria of the study despite being

Discussion

This prospective, randomized trial was designed to determine whether an intraperitoneal, bioprosthetic sublay using Surgisis Gold to reinforce a primary fascial closure would decrease the incidence of incisional hernia formation at 2 years postoperatively in patients undergoing elective open RYGB. Unfortunately, the study showed that there was no benefit of the use of this bioprosthesis within the confines of this study; the rate of incisional hernia formation with and without the bioprosthesis

References (21)

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