N/A
Completed N=402
Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery
Source: ClinicalTrials.gov NCT00274625 ↗Enrolled (actual)
402
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcomePrimary: Incisional Hernia — 32; 38 participants — p=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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incisional Hernia |
32; 38 | 0.60 |
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. Informational only — not medical advice.