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临床试验/CTRI/2025/02/080518
CTRI/2025/02/080518尚未招募Unknown

A prospective study of laparoscopic IPOM repair in 25 cases OF ventral hernia.

Vibhor Sachdeva1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年2月27日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
25
试验地点
1
主要终点
Post-operative pain

研究概览

简要总结

This prospective study evaluates the short-term outcomes of laparoscopic intraperitoneal onlay mesh (IPOM) repair in patients with midline primary ventral and incisional hernia. 25 patients with midline ventral hernias (defect size <10 cm) will be selected based on specific inclusion criteria. The primary objectives is to assess postoperative pain using changes in vas scores at different post op days(day 1, day 7, day 30). Secondary objectives are operative time, mesh fixation time, , hospital stay, seroma formation, and recurrence rates at 30 days, time to return to normal activities, and pain relief requirements 30 days post-discharge.

研究设计

研究类型
Interventional

入排标准

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

入选标准

  • 1.Uncomplicated Primary ventral or incisional hernia defects 2.Midline defect with an expected hernia width equal to or less than 10cm.
  • 3.Elective hernia repair 4.Considered eligible for hernia repair through a minimally-invasive approach.

排除标准

  • Lateral Hernia 2) Emergency procedure (for irreducible, strangulated or obstructed hernia) 3) Body Mass Index (BMI) greater than 40 4) Hernia defects considered to require an open approach.
  • Patient with associated groin hernia 6) Pregnant women 7) Recurrent Hernia 8) Associated Abdominal wall infection.

结局指标

主要结局

Post-operative pain

时间窗: Post-operative pain calculated using Vas score changes at day1, day 7 and day 30

次要结局

  • mesh fixation time(measured during operation)
  • operative time(measured during operation)
  • duration of hospital stay(days post operation)
  • time to return to daily activity(days taken to return to work counted from the day of operation)
  • any postop complication like ssi, seroma, early recurrence(upto 30 days post operation)

研究者

发起方
Vibhor Sachdeva
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Vibhor Sachdeva

Government Medical College Amritsar

研究点 (1)

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