临床试验/CTRI/2025/04/084850

CTRI/2025/04/084850尚未招募不适用

Comparing Sutures vs. N-hexyl cyanoacrylate glue mesh fixation in reducing postoperative pain in patients undergoing unilateral inguinal hernia repair-A single blinded randomized control trail

JIPMER1 个研究点分布在 1 个国家目标入组 80 人开始时间: 2025年5月10日最近更新: 2025年4月14日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: JIPMER
入组人数: 80
试验地点: 1
主要终点: To assess the efficacy of sutures vs. N-hexyl-cyanoacrylate for mesh fixation in reducing postoperative pain during elective primary unilateral inguinal hernia repair.fixation in reducing postoperative pain during elective primary unilateral inguinal hernia repair.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is going to be an RCT comparing two efficient methods of mesh fixation in elective hernia repair to compare the outcomes of surgery post operatively. Using sutures and N-hexyl-2cyanoacrylate we aim to compare the two in different aspects of probable improvement in the age old technique of Meshplasty with sutures which is widely used and is known to be commonly associated with post operative chronic pain.

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: 15.00 Year(s) 至 80.00 Year(s)（—）
性别: All

入选标准

•All consenting patients with primary elective unilateral uncomplicated inguinal hernia planned for open mesh repair.

排除标准

•1.Hernia patients with disorders of hemostasis and coagulation 2.Chronic pain due to previously operated opposite side or due to any other medical problem 3.Patient undergoing concomitant surgeries along with mesh repair.

结局指标

主要结局

To assess the efficacy of sutures vs. N-hexyl-cyanoacrylate for mesh fixation in reducing postoperative pain during elective primary unilateral inguinal hernia repair.fixation in reducing postoperative pain during elective primary unilateral inguinal hernia repair.

时间窗: day 0,1,2,7,30 of surgery

次要结局

1. To compare the short-term outcomes (local numb-ness & hematoma, seroma, rate of SSI, urinary reten-tion, length of operation, intraoperative time for mesh fixation, Length of hospital stay & time to return to work) between the two groups(2. To compare the long-term outcomes (Chronic pain, & recurrence) between the two groups)

研究者

发起方

JIPMER

申办方类型

Government medical college

责任方

Principal Investigator

主要研究者

Swaroop Johnson Michael

JIPMER

研究点 (1)

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