跳至主要内容
临床试验/CTRI/2024/11/076172
CTRI/2024/11/076172尚未招募4 期

Modified anterior preperitoneal mesh repair versus Lichtenstein mesh repair for inguinal hernias – A randomized controlled trial

ROHAILKAHND MEDICAL COLLEGE AND HOSPITAL1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年11月20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
64
试验地点
1
主要终点
1.Operative time taken in each procedure

研究概览

简要总结

A hernia is the protrusion of an organ or fatty tissue through the wall containing it, often due to weak muscle or connective tissue. Inguinal hernias are common, especially in males, often resulting from the descent of the testis during birth. This study aims to compare two surgical techniques for inguinal hernia repair: Modified Anterior Preperitoneal (mAPP) mesh repair and Lichtenstein mesh repair. Conducted as a randomized controlled trial at Rohilkhand Medical College, the study will include adult patients with inguinal hernias, excluding those with severe health issues or recurrent hernias The study will assess operative time, complications, postoperative pain, hospital stay, and recurrence rates over one year at Rohilkhand Medical College, ensuring ethical standards, including informed consent and data protection. Participants will be randomly assigned to either mAPP or Lichtenstein repair. The mAPP technique involves placing a polypropylene mesh in the preperitoneal space, while the Lichtenstein method involves exposing and reinforcing the inguinal canal with mesh. With a sample size of 32 in each group, data will be analyzed using statistical methods, with a significance level set at p < 0.05. This research seeks to evaluate the effectiveness of mAPP as an alternative to Lichtenstein repair. Both surgical techniques will be assessed for their effectiveness and associated complications.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All adult patients having inguinal hernia.

排除标准

  • 1.Patients having ASA Grade 3and 4 2.Recurrent hernia.

结局指标

主要结局

1.Operative time taken in each procedure

时间窗: During surgery any kind of complications occuring will be noted along with the time taken. A note will be taken of post operative complication, hospital stay, post operative pain and recurrance

2.Intra operative complications

时间窗: During surgery any kind of complications occuring will be noted along with the time taken. A note will be taken of post operative complication, hospital stay, post operative pain and recurrance

3.Postoperative pain

时间窗: During surgery any kind of complications occuring will be noted along with the time taken. A note will be taken of post operative complication, hospital stay, post operative pain and recurrance

4.Hospital stay

时间窗: During surgery any kind of complications occuring will be noted along with the time taken. A note will be taken of post operative complication, hospital stay, post operative pain and recurrance

5.Postoperative complications

时间窗: During surgery any kind of complications occuring will be noted along with the time taken. A note will be taken of post operative complication, hospital stay, post operative pain and recurrance

6.Recurrence in duration of study

时间窗: During surgery any kind of complications occuring will be noted along with the time taken. A note will be taken of post operative complication, hospital stay, post operative pain and recurrance

次要结局

  • To look for hernia recurrence during study period(Post surgery timely follow up will be done to note the hernia recurrence)

研究者

发起方
ROHAILKAHND MEDICAL COLLEGE AND HOSPITAL
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Omkumar Sharma

Rohailkhand medical college and hospital

研究点 (1)

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