Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 402
- 试验地点
- 4
- 主要终点
- Incisional Hernia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incisional Hernia
时间窗: 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.
次要结局
未报告次要终点