跳至主要内容
临床试验/CTRI/2025/12/099416
CTRI/2025/12/099416尚未招募3 期

Comparison of Short-term outcomes between Desardas tissue repair and Lichtensteins meshplasty in Inguinal hernia surgery: A Double blinded Randomized control trial

JIPMER (IMRF)1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2025年12月29日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
78
试验地点
1
主要终点
To determine and compare the incidence of Chronic groin pain (at 3months) measured by visual analogue scale (VAS) following Lichtenstein’s tension free meshplasty and Desarda’s tissue repair in patients undergoing unilateral primary inguinal hernia repair

研究概览

简要总结

Hernia has been continuing as one of the oldest and one of the most common common surgical pathology. The surgical intervention for hernia has taken leaps over the past few years. Starting with simple open procedures as Shouldice and bassini repair to, it has evolved over time to such complex laparoscopic and robotic surgeries[11]

 The comparison and contrast between Desarda’s tissue repair and Lichtenstein meshplasty for the repair of inguinal hernia has increasingly been discussed in medical literature to assess their effectiveness in both short-term and long-term outcomes. Desarda’s repair, described in the early 21st century, is a tension-free method that precludes the use of synthetic mesh by employing the external oblique aponeurosis to provide support to the abdominal wall. This technique has been recognized for its simplicity and the use of no foreign materials, thereby minimizing risks of complications such as chronic pain, infection, and rejection. Its shorter recovery time and lower incidences of post-operative pain have been noted in studies, and it is considered a promising alternative, especially in resource-limited environments.

The Lichtenstein meshplasty, on the other hand, is still the gold standard in hernia repair because of its established capacity to reduce recurrence rates. This method uses a polypropylene mesh to provide reinforcement to the compromised abdominal wall through a tension-free repair.[12]

 Though effective, it has been known to have complications like chronic pain related to the mesh, foreign body sensation, and, rarely, mesh migration. Randomized controlled trials and meta-analyses have yielded inconsistent findings when the two methods are compared, with some reporting similar success rates and others supporting one method over the other based on particular patient groups or surgical settings.

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 99.00 Year(s)(—)
性别
All

入选标准

  • All consenting patients above 18 years of age with primary unilateral uncomplicated inguinal hernia planned for elective open inguinal hernia repair.

排除标准

  • 未提供

结局指标

主要结局

To determine and compare the incidence of Chronic groin pain (at 3months) measured by visual analogue scale (VAS) following Lichtenstein’s tension free meshplasty and Desarda’s tissue repair in patients undergoing unilateral primary inguinal hernia repair

时间窗: 3 months

次要结局

  • Operating time
  • Operating time(-)
  • Early Post operative pain(Day 0, Day 1, 1 week)
  • Duration of hospital stay post operatively(In days)
  • Incidence of Early post operative complications (Hematoma formation)(Day 1, 1 week)
  • Incidence of Early post operative complications (Seroma formation)(Day 8, 1 month, 3 months)
  • Early hernia recurrence(3 months)
  • Quality of life (using SF36 & EuraHS-QoL scale)(3 months)

研究者

发起方
JIPMER (IMRF)
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Kommu Siddhartha Raj

JIPMER, Pondicherry

研究点 (1)

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