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CTRI Number  CTRI/2024/01/061886 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 06/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   LIRA vs IPOM Plus in Anterior Abdominal Wall Hernia Repair in terms of early post operative complications 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR VATSAL GUPTA 
Designation  PG RESIDENT 
Affiliation  Department of General Surgery 
Address  Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital New Delhi

Central
DELHI
110001
India 
Phone  7289053837  
Fax    
Email  drvatsalgupta@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR NEETI KAPUR 
Designation  PROFESSOR 
Affiliation  Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital 
Address  Department of General Surgery Dr. Ram Manohar Lohia Hospital New Delhi India

Central
DELHI
110001
India 
Phone  9818182212  
Fax    
Email  neetikapur2004@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  DR SHARDOOL VIKRAM GUPTA 
Designation  ASSISTANT PROFESSOR 
Affiliation  Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital 
Address  Department of General Surgery Dr. Ram Manohar Lohia Hospital New Delhi India

Central
DELHI
110001
India 
Phone  9971265738  
Fax    
Email  docshardool@gmail.com  
 
Source of Monetary or Material Support  
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital, NEW DELHI 
 
Primary Sponsor  
Name  ABVIMS and Dr RML Hospital New Delhi 
Address  Department of General surgery ABVIMS and Dr RML hospital New Delhi 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR VATSAL GUPTA  Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital  Department of general surgery, Dr Ram Manohar Lohia Hospital, New Delhi
Central
DELHI 
7289053837

drvatsalgupta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intraperitoneal Onlay Mesh Repair Plus (IPOM PLUS)  IPOM PLUS will be used for the treatment of ventral hernias over a period of 1 year. IPOM Plus is an established technique for ventral hernia repair.  
Intervention  Laparoscopic Intracorporeal Rectus Aponeuroplasty (LIRA)  LIRA will be used for the treatment of ventral hernias over a period of 1 year. LIRA is a relatively newer technique for ventral hernia repair. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ADULT PATIENTS WITH PRIMARY VENTRAL HERNIA 
 
ExclusionCriteria 
Details  Recurrent ventral hernia
Obstructed or strangulated hernia
ASA 3 or more 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Early post-operative complications
Pain
Seroma
Surgical site infection 
1 hour, 6 hours, 24 hours, 7 day, 30 day, 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Intra-op complications
Operative Time
Length of hospital stay 
1 month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/02/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/08/2024 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 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.

 
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