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临床试验/CTRI/2025/09/094395
CTRI/2025/09/094395招募中不适用

A Comparative Study To Evaluate The Efficacy Of Two Minimally Invasive Techniques For Repair Of Small Umbilical Hernias Using Dual Layered Patch Mesh

HBT Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月20日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
To Compare Outcomes Of Patient Undergoing Open V/S Laparoscopic Intraperitoneal Onlay Meshplasty For Umbilical/Paraumbilical Hernias Using Same Dual Layered Composite Circular Mesh

研究概览

简要总结

We will be conducting a prospective randomised case-control study at a single urban tertiary care centre,It involves 60 adult patients, above 18 years with uncomplicated umbilical hernias scheduled for ipom vs open umbilical hernia both with patch mesh plasty.All having defect size <3cm

Two groups were assigned randomly : Group A of 30 patients are operated using laparoscopic ipom technique  and Group B 30 patients with open umbilical hernia repair. To compare outcomes of patients undergoing open intraperitoneal mesh plasty v/s Laparoscopic intraperitoneal onlay mesh plasty for umbilical/ paraumbilical hernias using the same dual layered Composite circular mesh.To compareintra-operative time, mesh placement time, and shift out of ot time.Wound healing, post-operative pain, ssi rates, time to discharge after surgery,  early recurrence We will analyse the data using Microsoft Excel and SPSS version 21 software. ethical approval and secured informed consent for participating in case study as well as undergoing operation will be taken separately .The study aims to provide empirical evidence regarding the potential advantages of specifically in clinical guidance ,operative time ,reducing complications, improving patient well-being ,assessment to new advances.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients with umbilical and paraumbilical hernia with defect size less than 3 cm and undergoing elective surgery.
  • Age between 18 to 80 years.
  • Consenting for the study.

排除标准

  • Patients not consenting for the study.
  • Patients with umbilical/paraumbilical hernia with defect size more than 3 cm
  • Recurrent/ incisional hernias
  • Any other hernia except umbilical and paraumbilical hernias.

结局指标

主要结局

To Compare Outcomes Of Patient Undergoing Open V/S Laparoscopic Intraperitoneal Onlay Meshplasty For Umbilical/Paraumbilical Hernias Using Same Dual Layered Composite Circular Mesh

时间窗: 8 weeks

次要结局

  • 1. To Compare Intra-Operative Time & Meshplacement Time During Both The Procedures(2. To Assess Complications With Both Procedures With Respect To Post-Operative Pain, Ssi Rates And Early Recurrence.)

研究者

发起方
HBT Medical College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Charmi Mistry

HBT MEDICAL COLLEGE & DR. R. N. COOPER HOSPITAL

研究点 (1)

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