跳至主要内容
临床试验/CTRI/2023/03/050605
CTRI/2023/03/050605尚未招募不适用

Extended view totally extraperitoneal Rives Stoppa (e-TEP RS) versus laparoscopic intraperitoneal onlay mesh (IPOM) plus repair for ventral hernia-A Randomized controlled study

Binit Sharma1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年3月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Operative time defined from incision to last stitch between e-TEP RS versus IPOM plus

研究概览

简要总结

Primary and incisional ventral hernias repairs have always been a challenge for surgeons. In the current era, so many different options for the management of these hernias are available from various open to minimal invasive techniques, and this diversity of techniques makes the decision making more difficult in ventral hernia. Surgeons are still in a search of the ideal or standardized method that adequately decreases postoperative complications and improves quality of life. According to latest evidence, laparoscopic techniques have the advantage of shorter hospital stay after surgery, early resumption of work, and lesser surgical wound complications as compared to open techniques. From IPOM to e-TEP, minimal invasive procedures for ventral hernia repair with different techniques and mesh positions have evolved rapidly in the last decade. e-TEP offers the benefit of a minimally invasive procedure along with mesh in sublay/retrorectus position, hence avoiding the intra-abdominal mesh-related complications. .Another advantage of e-TEP in large ventral hernia is that if closure is difficult or not possible, then posterior component separation technique in the form of transversus abdominis release can be combined as the plane of dissection is the same. As per available evidence, it is believed that mesh in sublay position offers superior quality of postoperative connective tissue formation, less recurrence, and less cost as compared to composite mesh with anti-adhesion barrier used for intra-peritoneal position. The current data are lacking, as till now only one retrospective comparative study by Penchev et al. of both the approaches has been published.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • All cases of midline ventral hernia(M2,M3) in central or lower abdomen between age 18-75 years.

排除标准

  • Patients with defect size > 6cm
  • Recurrent Hernias
  • Emergency cases
  • Hernia with skin infections and enterocutaneous fistula
  • BMI more than 35.

结局指标

主要结局

Operative time defined from incision to last stitch between e-TEP RS versus IPOM plus

时间窗: Duration of operation defined from incision to last stitch between e-TEP RS versus IPOM plus

次要结局

  • 1. Postoperative pain using VAS score at 1day, 1week, 6 week postop(2. Duration of hospital stay(Days))

研究者

发起方
Binit Sharma
申办方类型
Other [self]

研究点 (1)

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