Clinical trial NCT00274625: Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia
Obesity
Keywords: Biomaterials
Bariatric Surgery
Hernia, Prevention of
Obesity
Bypass Surgery
Incisional Hernia
Ventral Hernia
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
Collaborators: name: Cook Biotech Incorporated
name: MED Institute, Incorporated
First posted: 2006-01-11
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incisional Hernia
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Foundation
state: Minnesota
city: Richmond
country: United States
facility: St. Mary's Medical
state: Virginia
Study officials:
affiliation: Mayo Clinic Foundation
name: Michael Sarr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sarr MG, Hutcher NE, Snyder S, Hodde J, Carmody B. A prospective, randomized, multicenter trial of Surgisis Gold, a biologic prosthetic, as a sublay reinforcement of the fascial closure after open bariatric surgery. Surgery. 2014 Oct;156(4):902-8. doi: 10.1016/j.surg.2014.06.022.