Prospective Randomized Multicenter Trial Comparing Laparoscopic (IPOM) vs. Sublay Mesh Plasty for Umbilical Hernia in Adults
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 306
- 试验地点
- 6
- 主要终点
- early wound complications
研究概览
简要总结
This study is designed to compare two techniques for operative care of umbilical hernia in adults regarding wound complications, wound side fluid collections, recurrence rate, postoperative pain, duration of hospitalization and quality of life. The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind the rectus muscle after small incision close to the belly button.
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
- •informed consent
- •patient age: ≥ 18 years
- •elective surgery for umbilical hernia
- •hernia diameter ≥ 1cm
排除标准
- •previous history of median laparotomy
- •navel site infection
- •contraindication for general anaesthesia
- •American Society of Anesthesiologists (ASA) score >IV
- •pregnancy
- •cirrhosis of the liver (CHILD B and C) and/or ascites
- •cytostatic therapy
- •incarcerated hernia
- •recurrent hernia
结局指标
主要结局
early wound complications
时间窗: 30 days after operation
* wound infection (with or without removal of the mesh) * wound necrosis * wound hematoma
late wound complications
时间窗: 1 year after operation
* wound infection (with or without removal of the mesh) * wound necrosis * wound hematoma
次要结局
- hospital stay(will be measured after discharge of the patient)
- complication rate postoperative(5 years)
- navel site seroma(after 1 year)
- pain score (Visual Analog Scale - VAS)(immediately before discharge)
- complication rate perioperative(intraoperative complications will be recorded immediately after finishing the operation)
- duration of operation(the duration will be recorded immediately after finishing the operation)
- umbilical hernia recurrence rate(5 years)
- Quality of life (SF-36)(1 year postoperatively)