Hernia, Obesity
Conditions
Keywords
Biomaterials, Bariatric Surgery, Hernia, Prevention of, Obesity, Bypass Surgery, Incisional Hernia, Ventral Hernia
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.
Interventions
DEVICESurgisis Gold Graft
Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
PROCEDUREControl
Incision is closed without the placement of a graft material (standard of care control)
Sponsors
Cook Biotech Incorporated
MED Institute, Incorporated
Cook Group Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Surgisis Gold Surgisis Gold Graft is placed as an underlay following open bariatric surgery. | 185 |
| Suture Closure Control : Incision is closed without the placement of a graft material (standard of care control) | 195 |
| Total | 380 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Excluded from analysis | 14 | 8 |
| Overall Study | Lost to Follow-up | 46 | 54 |
Baseline characteristics
| Characteristic | Surgisis Gold | Suture Closure | Total |
|---|---|---|---|
| Age, Continuous | 44.6 years STANDARD_DEVIATION 10.6 | 45.1 years STANDARD_DEVIATION 12.1 | 44.8 years STANDARD_DEVIATION 11.4 |
| BMI (Body mass index) | 48.2 kg/m^2 STANDARD_DEVIATION 8.2 | 48.2 kg/m^2 STANDARD_DEVIATION 7.7 | 48.2 kg/m^2 STANDARD_DEVIATION 7.9 |
| Sex: Female, Male Female | 146 Participants | 156 Participants | 302 Participants |
| Sex: Female, Male Male | 39 Participants | 39 Participants | 78 Participants |
| Weight | 138 kg STANDARD_DEVIATION 30 | 143 kg STANDARD_DEVIATION 34 | 140.6 kg STANDARD_DEVIATION 32.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 87 / 185 | 62 / 195 |
| serious Total, serious adverse events | 0 / 185 | 0 / 195 |
Outcome results
Primary
Incisional Hernia
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.
Time frame: 2 years
Population: 14 patients in Surgisis Gold group and 8 patients in Suture Closure group were excluded from the analysis, because prior to procedure, either they were found not to meet the inclusion/exclusion criteria, or they chose not to participate.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Surgisis Gold | Incisional Hernia | 32 participants |
| Suture Closure | Incisional Hernia | 38 participants |
p-value: 0.6Fisher Exact