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临床试验/CTRI/2024/01/062167
CTRI/2024/01/062167尚未招募Phase 3 4

Laparoscopic Extended Totally Extraperitoneal Repair (eTEP) versus Robotic Transabdominal Preperitoneal (Rtapp) Inguinal Hernia Repair: A randomized Control Trial

Department of General Surgery AIIMS Jodhpur1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年1月10日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
36
试验地点
1
主要终点
Surgical Operative Time

研究概览

简要总结

More than 20 million hernia repairs carried worldwide. With avident of modern technology hernia repair is shifting from laparoscopic to robotic techniques. We are trying to compare laparoscopic extended totally extraperitoneal repair (eTEP) versus robotic Transabdominal preperitoneal (rTAPP) inguinal hernia repair in terms of operative time , post operative pain and other variables. The Prospective observational study will be conducted in Department of General Surgery  at AIIMS, Jodhpur after obtaining the approval of institutional research committee and institutional ethics committee. Participants who meet the inclusion and exclusion criteria will be included in the study. Their demographics will be collected. On presentation after recruitment of the patient for study, complete history taking and general physical examination followed by routine investigation and special investigations will be done. Patient’s will be worked up for surgery as per institute protocol. When they undergo surgery, we will observe operative time, postoperative pain and various other factors. The patient will be monitored closely during there hospital stay for any postoperative complications, clavein dindo and modified clavein dindo score will be used. All the clinical parameters and the information obtained will be thoroughly assessed to fulfil the aim of the study and conclusion will be drawn.

P - Adult patient with unilateral inguinal hernia

I - Robotic TAPP

C - Laparoscopic eTEP O - Operative time T - Not applicable

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 99.00 Year(s)(—)
性别
All

入选标准

  • All consenting adult patients (18 years) with uncomplicated inguinal hernia coming to General Surgery OPD, AIIMS Jodhpur.

排除标准

  • Not consenting to participate in the study Patient not fit to be operated under general anaesthesia Recurrent hernia and strangulated hernia (complicated hernias).

结局指标

主要结局

Surgical Operative Time

时间窗: Intraoperative

次要结局

  • Post operative pain(Seroma)

研究者

发起方
Department of General Surgery AIIMS Jodhpur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Mranal Karoliya

AIIMS Jodhpur

研究点 (1)

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