Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery

Not Applicable

Completed

• Conditions: Obesity; Hernia
• Interventions: Device: Surgisis Gold Graft; Procedure: Control

• Registration Number: NCT00274625
• Lead Sponsor: Cook Group Incorporated

Brief Summary

The primary objective is to compare the effectiveness of the Surgisis Gold Graft to suture closure alone in preventing an incisional hernia after open bariatric surgery.

Detailed Description

This will be a prospective, randomized clinical trial comparing outcomes of use of a sublay of Surgisis Gold Graft for tissue reinforcement, as compared to suture closure alone in evaluating incidence of incisional hernias. Prior to undergoing open bariatric surgery, patients will be randomized to receive either Surgisis Gold Graft or suture closure alone. Subjects will be seen for follow-up visits at six weeks, three months, six months, one year and two years post-operatively. Patients may see their primary care physician for the one and two follow-up visits.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2006-01-09
• Study First Submitted QC: 2006-01-09
• Study First Posted: 2006-01-11
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Results First Submitted: 2014-10-24
• Status Verified: 2014-11
• Results First Submitted QC: 2014-11-10
• Last Update Submitted: 2014-11-10
• Results First Posted: 2014-11-12
• Last Update Posted: 2014-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 402

Inclusion Criteria

• Planned operative approach via upper midline incision with goal of weight loss
• 18 years of age or older
• Body mass index (BMI) >= 30 kg/m2
• Documented history of non-surgical attempts at weight loss
• Patients undergoing reoperation for a failed previous bariatric procedure are eligible provided the operation is being performed for weight loss and provided at the time of reoperation there is no incisional hernia
• Patients with small, non-incarcerated, previously unrepaired umbilical hernias are acceptable provided the hernia defect is no greater than 2.5 cm in diameter

Exclusion Criteria

• Patients with pre-existing midline abdominal wall incisional hernia or diastasis rectus
• Patients undergoing repeat bariatric surgery for complications of a previous bariatric procedure
• Patients with a previous upper midline incision found to have an incisional hernia
• Patients with connective tissue disorders known to predispose to hernia formation
• Active infection at the time of proposed surgery
• Sensitivity or religious objections to porcine products

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Surgisis Gold Graft	Surgisis Gold Graft
2	Control	Control

Primary Outcome Measures

Name	Time	Method
Incisional Hernia	2 years	An obvious defect or interruption of the fascia in the area of the incision that was palpable on clinical examination and/or visible by a cross-sectional imaging modality.

Trial Locations

Locations (2)

Mayo Clinic Foundation; 🇺🇸 Rochester, Minnesota, United States

St. Mary's Medical; 🇺🇸 Richmond, Virginia, United States