N/A
N=402
Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery
Hernia · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00274625 ↗Enrolled (actual)
402
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Incisional Hernia — 32; 38 participants — p=0.60
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Surgisis Gold Graft (Device); Control (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cook Group Incorporated
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incisional Hernia |
32; 38 | 0.60 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00274625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.