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临床试验/NCT03255239
NCT03255239Unknown不适用

Randomized Clinical Trial Comparing Open Preperitoneal Mesh, Retromuscular Mesh and Suture Repair for Abdominal Wall Hernias Less Than 3 cm Diameter

Hôpital Universitaire Taher Sfar2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年8月1日最近更新:
适应症
干预措施

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

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

Experimental

Ventral hernia repair using polyester preperitoneal mesh repair

干预措施: Ventral hernia repair (Procedure)

Retromuscular mesh repair

Experimental

Ventral hernia repair using polyester retromuscular mesh repair

干预措施: Ventral hernia repair (Procedure)

Suture repair

Experimental

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

发起方
Hôpital Universitaire Taher Sfar
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mohamed Ali Chaouch

Resident of general surgery

Hôpital Universitaire Taher Sfar

研究点 (2)

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