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临床试验/CTRI/2025/02/080143
CTRI/2025/02/080143尚未招募2/3 期

Randomized Controlled Trial of Laparoscopic Transabdominal Preperitoneal Repair (TAPP) versus Laparoscopic Total Extraperitoneal Repair (TEP) versus Lichtenstein Open Repair for inguinal hernia in a tertiary care hospital in Nagpur

Dr Keshav Mittal1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年2月17日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
72
试验地点
1
主要终点
1) Intra Operative Length Of Surgery

研究概览

简要总结

An inguinal hernia is a defect in the endo-abdominal fascia of sufficient size to allow escape of intraperitoneal or pre-peritoneal contents into the groin. Inguinal hernias usually present as a lump, with or without some discomfort, which may limit daily activities and the ability to work. They can occasionally be life-threatening if the bowel strangulates or becomes obstructed. The definitive treatment of inguinal hernia is surgery. The open Lichtenstein mesh repair of inguinal hernia has become a standard for inguinal hernia repair but the introduction of laparoscopic techniques have shown acceptable results in a number of literature. The different surgeries performed are:

  1. Laparoscopic Trans Abdominal Preperitoneal Repair (TAPP):: Laparoscopic treatment procedure , in which hernia repair and mesh placement will be between the peritoneal layers.

  2. Laparoscopic Total Extraperitoneal Repair (TEP):: Laparoscopic treatment procedure , in which hernia repair and mesh placement will be entirely outside the peritoneum , and cavity won’t be breached.

  3. Open Lichtenstein mesh repair: Open treatment procedure , with larger scar

There are very few studies comparing laparoscopic inguinal hernioplasty with tension free open mesh hernia repair and, moreover, with Lichtenstein repair. Therefore, this study aims to to evaluate and compare the safety and efficacy of Laparoscopic (TAPP AND TEP) versus Open Repair among patients with clinically or radiologically proven Inguinal Hernia

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Pts aged more than 18years -Unilateral or Bilateral hernia.

排除标准

  • Recurrent inguinal hernia -Obstructed hernia -Strangulated hernia -Irreducible Inguinal hernia -Patients below 18 years age.

结局指标

主要结局

1) Intra Operative Length Of Surgery

时间窗: 1) Intra Operative Length Of surgery | 2) Day 1,3 and 7 | 3) Length Of Hospital Stay | 4) Day 1,3 and 7 | 5) Return to normal acivities after surgery | 6) At 1 month, 3 month, 6 month and 1 year

2) Post Operative Pain

时间窗: 1) Intra Operative Length Of surgery | 2) Day 1,3 and 7 | 3) Length Of Hospital Stay | 4) Day 1,3 and 7 | 5) Return to normal acivities after surgery | 6) At 1 month, 3 month, 6 month and 1 year

3) Length Of Hospital stay

时间窗: 1) Intra Operative Length Of surgery | 2) Day 1,3 and 7 | 3) Length Of Hospital Stay | 4) Day 1,3 and 7 | 5) Return to normal acivities after surgery | 6) At 1 month, 3 month, 6 month and 1 year

4)Wound Infection- SSI, Seroma, Hematoma, Pain or tenderness

时间窗: 1) Intra Operative Length Of surgery | 2) Day 1,3 and 7 | 3) Length Of Hospital Stay | 4) Day 1,3 and 7 | 5) Return to normal acivities after surgery | 6) At 1 month, 3 month, 6 month and 1 year

5) Return to normal activities after surgery

时间窗: 1) Intra Operative Length Of surgery | 2) Day 1,3 and 7 | 3) Length Of Hospital Stay | 4) Day 1,3 and 7 | 5) Return to normal acivities after surgery | 6) At 1 month, 3 month, 6 month and 1 year

6) Quality of Life using 36-item Short form survey (SF-36)

时间窗: 1) Intra Operative Length Of surgery | 2) Day 1,3 and 7 | 3) Length Of Hospital Stay | 4) Day 1,3 and 7 | 5) Return to normal acivities after surgery | 6) At 1 month, 3 month, 6 month and 1 year

次要结局

未报告次要终点

研究者

发起方
Dr Keshav Mittal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Keshav Mittal

All India Institute Of Medical Sciences,Napur

研究点 (1)

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