跳至主要内容
临床试验/CTRI/2022/04/041759
CTRI/2022/04/041759尚未招募4 期

A PROSPECTIVE, RANDOMISED CONTROLLED STUDY TO COMPARE INTRAPERITONEAL ONLAY MESH PLUS REPAIR VERSUS TRANSABDOMINAL PRE PERITONEAL MESH PLUS REPAIR FOR PATIENT WITH VENTRAL HERNIA

ESIC Medical College and Hospital Faridabad1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月5日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare postoperative morbidity including the pain scores and seroma rate

研究概览

简要总结

Ventral hernia is the leading cause of abdominal pain, functional impairment and subacute intestinal obstruction. Large comparative studies have shown the advantage of laparoscopic repair over open repair. Conventional laparoscopic repair as popularised by Blanc and Booth in 1993 involves intraperitoneal placement of mesh. Limitation of which includes the requirement of costly composite mesh and fixating device. Also in few cases intraperitoneal mesh may lead to intestinal obstruction and perforation. The current trend among hernia surgeons is to place the mesh extraperitoneally or pre-peritoneally to avoid all the mesh related complications. The only limitation of pre-peritoneal mesh placement is slightly longer operative time and requirement of advanced laparoscopic skills. However there is paucity of literature comparing IPOM with TAPP which is limited to only few retrospective studies. Hence we are planning to conduct this prospective randomised  controlled study to know the advantages of one over another.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Age ≥ 18 years Ventral hernia (Primary or Incisional) Defect size 2-8 cm.

排除标准

  • Patients undergoing emergency surgery
  • Parastomal or recurrent hernias
  • Unfit for General anesthesia and Laparoscopy.

结局指标

主要结局

To compare postoperative morbidity including the pain scores and seroma rate

时间窗: 6hr, 24hr, 72 hr and than at 7, 30, 90, 180 and 360 days

次要结局

  • To compare length of hospital stay, surgical site infection (SSI), hernia recurrence, mesh infection, cost, operative time and patient quality of life

研究者

发起方
ESIC Medical College and Hospital Faridabad
申办方类型
Government medical college

研究点 (1)

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