LIRA vs IPOM Plus in Anterior Abdominal Wall Hernia Repair in terms of early post operative complications

Phase 3

Completed

Conditions: Medical and Surgical, (2) ICD-10 Condition: K432||Incisional hernia without obstruction or gangrene, (3) ICD-10 Condition: K439||Ventral hernia without obstructionor gangrene, (4) ICD-10 Condition: K429||Umbilical hernia without obstruction or gangrene,

Registration Number: CTRI/2024/01/061886

Lead Sponsor: ABVIMS and Dr RML Hospital New Delhi

Brief Summary: 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 projectâ€”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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

ADULT PATIENTS WITH PRIMARY VENTRAL HERNIA.

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early post-operative complications	1 hour, 6 hours, 24 hours, 7 day, 30 day, 3 months
Pain	1 hour, 6 hours, 24 hours, 7 day, 30 day, 3 months
Seroma	1 hour, 6 hours, 24 hours, 7 day, 30 day, 3 months
Surgical site infection	1 hour, 6 hours, 24 hours, 7 day, 30 day, 3 months

Secondary Outcome Measures

Name	Time	Method
Intra-op complications	Operative Time

Trial Locations

Locations (1): Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital
🇮🇳
Central, DELHI, India
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital
🇮🇳Central, DELHI, India
DR VATSAL GUPTA
Principal investigator
7289053837
drvatsalgupta@gmail.com