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临床试验/CTRI/2026/04/108275
CTRI/2026/04/108275尚未招募不适用

Comparative Evaluation of Suture Ligation of the Processus Vaginalis versus Herniotomy sans ligation in Pediatric Hydrocele Repair: A Randomized Controlled Trial

Multi disciplinary research unit Netaji Subhas Chandra Bose Medical College Jabalpur MP INDIA1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年4月24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
100
试验地点
1

研究概览

简要总结

This randomized controlled trial aims to compare suture ligation of the processus vaginalis with herniotomy without ligation in children undergoing surgery for hydrocele. Pediatric hydrocele repair is commonly performed using traditional high ligation, although newer sutureless techniques may reduce operative time and avoid suture-related complications. However, high-quality comparative evidence is lacking.

A total of 100 children aged 1 to 12 years with congenital hydrocele will be randomly assigned to two groups. One group will undergo conventional herniotomy with suture ligation, while the other will undergo herniotomy without ligation. The primary outcome is operative time, recurrence. Secondary outcomes include postoperative complications such as edema, hematoma, and infection, need for reoperation, and recovery parameters.

The study is a parallel-group, assessor-blinded, randomized trial conducted at a tertiary care center. Follow-up will last up to 12 months to assess recurrence and complications.

This study aims to provide evidence on the safety and effectiveness of sutureless herniotomy and may help improve surgical practice in pediatric hydrocele repair by reducing operative time without increasing recurrence or complications.

研究设计

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

入排标准

年龄范围
1.00 Year(s) 至 12.00 Year(s)(—)
性别
Male

入选标准

  • Age 1 to 12 years Unilateral or bilateral congenital hydrocele that requires surgical intervention.

排除标准

  • 未提供

研究者

发起方
Multi disciplinary research unit Netaji Subhas Chandra Bose Medical College Jabalpur MP INDIA
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Rajpal Singh Sisodiya

Netaji Subhas Chandra Bose,Medical college,Jabalpur MP

研究点 (1)

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