跳至主要内容
临床试验/CTRI/2024/07/070887
CTRI/2024/07/070887尚未招募不适用

Comparison of TEP vs eTEP technique for groin hernia repair in terms of post operative outcomes and learning curve : A Randomized trial

Dr. Asuri Krishna1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2024年7月29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
94
试验地点
1
主要终点
Post operative pain, Wound infection, Seroma, Early Recurrence

研究概览

简要总结

Inguinal hernia is one of the most common problems in surgical patients. Various approaches are available for inguinal hernia repair. In this study, we will include two techniques eTEP and TEP for inguinal hernia repair. TEP has been commonly used previously but it has been cumbersome due to poor ergonomics and small operating space. Beside this, larger size mesh can be placed.

Our primary objective is to compare the postoperative outcome of eTEP and TEP repair for groin hernia in terms of complications - Post operative pain, Wound infection, Seroma and Early Recurrence. By exploring the data from this study, we aim to provide insights into potential difference in outcomes. Secondarily, the quality of life will be assessed pre operatively at the time of admission using Quality of life assessment proforma (WHO-QOL BREF) in Hindi/English. The same performa will be used 3 months post operatively in all domains of WHOQOL-BREF i.e., physical, psychological, social, environmental. Patients will be operated by two group of surgeons : Group 1 - Surgeon with extensive experience in laparoscopic groin hernia repair , Group 2 - Surgeon with extensive experience in basic and advanced laparoscopic surgery but inexperienced in groin hernia surgery. Considering the better ergonomics in eTEP technique and lesser postoperative complications with shorter learning curve, we propose this randomized trial to compare eTEP and TEP.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Adult patients in the age group of 18-65 years with groin hernia.

排除标准

  • Complicated hernia (strangulated) Patients unfit for general anesthesia Patients who refused to give consent.

结局指标

主要结局

Post operative pain, Wound infection, Seroma, Early Recurrence

时间窗: At 6 hours, 24 hours, 1 week and 3months

次要结局

  • the ease of operability, patient’s quality of life(WHOQOL-BREF), learning curve(patient’s quality of life(WHOQOL-BREF) at the time of admission and at 3 months)

研究者

发起方
Dr. Asuri Krishna
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Asuri krishna

All India Institute of Medical Sciences, New Delhi

研究点 (1)

Loading locations...

相似试验