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临床试验/CTRI/2024/01/061886
CTRI/2024/01/061886已完成Phase 3 4

A randomised controlled study to compare Laparoscopic Intracorporeal Rectus Aponeuroplasty (LIRA) and Intraperitoneal Onlay Mesh Repair (IPOM Plus) Plus in terms of early post-operative complications in ventral hernia repair

ABVIMS and Dr RML Hospital New Delhi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月2日最近更新:

试验速览

阶段
Phase 3 4
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Early post-operative complications

研究概览

简要总结

Hernia is defined as abnormal protrusion of an organ or tissue through an opening in the layer of the body that normally contains it.

Hernias may be broadly divided into two main groups, depending on whether they develop in the upper abdomen or in the groin, and each group contains multiple types.

The European Hernia Society (EHS) has introduced a system of classifications of inguinal and ventral (primary and incisional) hernias. , which is used in another EHS project—the European Registry of Abdominal Wall Hernias.

The presentation of a ventral hernia is usually pain, swelling or fullness at the site of occurrence that can change with position or Valsalva, except in case of incarcerated or strangulated hernias, which may cause erythema and asymmetry as well. In most cases, the diagnosis of a ventral hernia can be made by history and physical exam.

The placement of an intraperitoneal mesh (IPOM) bridging the defect was related to a bulging effect after a certain period of time (pseudo-recurrence). An alternative in order to avoid this last problem and to increase the functionality of the abdominal wall was proposed by performing the closure of the defect by laparoscopy before placing the mesh (IPOM Plus), although some studies have suggested that the tension generated in the midline by closure of defect could be associated with an increase in the rate of pain and recurrence.

These problems led to the development of Laparoscopicintracorporeal rectus aponeuroplasty (LIRA), a new laparoscopic technique for the treatment of ventral moderate defects by J Gomez-Menchero et al in 2017. This technique combines the advantages of both concepts: the minimally invasive approach and the abdominal wall reconstruction associated to Closure of defect, allowing a restoration of the midline without tension, by the plication of the posterior aponeurosis of both abdominal rectus muscles combined with a laparoscopic intraperitoneal prosthetic repair (intraperitoneal onlay mesh).

This study aims at comparing the efficiency, advantages, disadvantages, limitations, early post-operative complications defined by post-operative pain, seroma formation, surgical site infection and recurrence of hernia with Laparoscopicintracorporeal rectus aponeuroplasty (LIRA) and Intraperitoneal onlay mesh plus repair (IPOM Plus repair) to determine whether these techniques are comparable.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ADULT PATIENTS WITH PRIMARY VENTRAL HERNIA.

排除标准

  • Recurrent ventral hernia Obstructed or strangulated hernia ASA 3 or more.

结局指标

主要结局

Early post-operative complications

时间窗: 1 hour, 6 hours, 24 hours, 7 day, 30 day, 3 months

Pain

时间窗: 1 hour, 6 hours, 24 hours, 7 day, 30 day, 3 months

Seroma

时间窗: 1 hour, 6 hours, 24 hours, 7 day, 30 day, 3 months

Surgical site infection

时间窗: 1 hour, 6 hours, 24 hours, 7 day, 30 day, 3 months

次要结局

  • Intra-op complications(Operative Time)

研究者

发起方
ABVIMS and Dr RML Hospital New Delhi
申办方类型
Government medical college

研究点 (1)

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