A Longitudinal Prospective Outcomes Study of Laparoscopic Abdominal Wall Hernia Repair Using Symbotex™ Composite Mesh
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Reoperation Rate
研究概览
简要总结
This study is being done to test the efficacy of Symbotex™ as an effective synthetic mesh option in the repair of grade I and II ventral hernias.
详细描述
This study is being done to validate the efficacy of Symbotex™ as an effective synthetic mesh option in the repair of grade I and II ventral hernias. It will also set the groundwork for a future clinical trial in which the efficacy of Symbotex® can be compared to other synthetic mesh products on the market.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Age 18 or older
- •Grade I or II ventral hernia according to VHWG classification system
- •Pre-operative informed consent is obtainable
排除标准
- •Not candidate for laparoscopic approach for repair of their hernia
- •Determination in the operating room that biologic mesh is needed over permanent mesh
- •Fascial defect less than 3 cm in greatest dimension
- •Concurrent placement of another mesh (synthetic or biologic ) at the site where the study mesh is placed
- •Grade III or IV ventral hernia according to VHWG system
- •ASA score IV or above
- •Any disease or condition along with the surgeon's clinical judgment that contraindicates the use of study mesh. These include but are not limited to the presence of chronically infected tissues subjecting patient to risk of synthetic mesh infection, accidental bowel injury during surgery or anatomy of the patient that is not receptive to laparoscopic surgery or mesh implantation.
- •Pregnancy
- •Use of more than one of the same study mesh is not an exclusion criterion in and of itself, so long as the type of mesh is selected according to the randomization protocol. In other words, if the hernia defect is larger than the largest Symbotex™ mesh available, two or more Symbotex mesh pieces may be used to appropriately repair the hernia defect.
结局指标
主要结局
Reoperation Rate
时间窗: One year
Hernia Recurrence
时间窗: One year
Quality of Life
时间窗: One year
Hernia associated pain and movement limitations pre-surgery compared to post-surgery
时间窗: One year
Percutaneous Intervention Rate
时间窗: One year
Number of Participants with Adverse Events as a Measure of Safety and Tolerability"
时间窗: One year
次要结局
未报告次要终点