Randomized Clinical Trial Comparing Open Preperitoneal Mesh, Retromuscular Mesh and Suture Repair for Abdominal Wall Hernias Less Than 3 cm Diameter
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Recurrence rates
研究概览
简要总结
Randomized clinical trial comparing open preperitoneal mesh, retromuscular mesh and suture repair for ventral hernias less than 3 cm diameter
详细描述
Many techniques of ventral hernias repair have been reported. It is shown that open mesh hernia repairs have low recurrence and low complication rates then suture repair. But for hernias less than 3 cm some surgeons defend the treatment by suture. The main variable of interest is the location of mesh placement compared to suture repair. The investigator will compare in a prospective randomized clinical trial three techniques of abdominal wall hernia repair: preperitoneal polyester mesh, retromuscular polyester mesh and suture for hernias less than 3 cm. All patients underwent general anesthesia. The investigators used Polyester-based mesh because it has shown minimal shrinkage and excellent tissue ingrowth in animal models. Operative notes were physician-abstracted and the presence, type, and location of mesh prosthesis was recorded. Independent variables of interest were patient-level demographics (age and sex), facility where hernia repair occurred, year of hernia repair, preoperative comorbid conditions, history of prior repair, and intraoperative variables. The results compared postoperative pain was evaluated using a visual analogue scale (range, 0-10) on the day of the first outpatient visit, operating time evaluated as skin-to-skin time, drain management and both of early and late complications including seroma and hematoma formation, wound infection, fistula formation and recurrence rates.
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 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Vebtral hernia or post incisional hernia diameter < 3 cm
- •Male or female aged between 18 and 90 year-old
- •Elective surgery for ventral hernia
排除标准
- •Any contraindication to the prosthetic treatment.
- •Any hernia or incisional hernia with a collar strictly greater than 3 cm.
- •Previous hernia mesh repaired
- •contraindication for general anaesthesia
- •Pregnancy
研究组 & 干预措施
Preperitoneal mesh repair
Ventral hernia repair using polyester preperitoneal mesh repair
干预措施: Ventral hernia repair (Procedure)
Retromuscular mesh repair
Ventral hernia repair using polyester retromuscular mesh repair
干预措施: Ventral hernia repair (Procedure)
Suture repair
Ventral hernia repair using suture repair
干预措施: Ventral hernia repair (Procedure)
结局指标
主要结局
Recurrence rates
时间窗: One year
Late complications of ventral hernia repair
次要结局
- Operating time(15 to 90 minutes)
- Early complication(30 days)
- Postoperative pain(6, 12 and 24 hours)
研究者
Mohamed Ali Chaouch
Resident of general surgery
Hôpital Universitaire Taher Sfar
