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CTRI Number  CTRI/2023/03/050605 [Registered on: 13/03/2023] Trial Registered Prospectively
Last Modified On: 09/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Comparative study between two operative procedures for ventral hernia eTEP RS and IPOM plus 
Scientific Title of Study   Extended view totally extraperitoneal Rives Stoppa (e-TEP RS) versus laparoscopic intraperitoneal onlay mesh (IPOM) plus repair for ventral hernia-A Randomized controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Binit Sharma 
Designation  Post graduate trainee 
Affiliation  Maulana Azad medical college  
Address  2, Bahadur shah Zafar marg, MAMC Campus,New Delhi, Delhi-110002
2, Bahadur shah Zafar marg, New Delhi, Delhi-110002
Central
DELHI
110002
India 
Phone  7003613007  
Fax    
Email  Sharma.binit2013@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pawanindra Lal 
Designation  Director professor and HOD 
Affiliation  Maulana Azad medical college  
Address  2, Bahadur shah Zafar marg, MAMC Campus,New Delhi, Delhi-110002
2, Bahadur shah Zafar marg, New Delhi, Delhi-110002
Central
DELHI
110002
India 
Phone  9891209609  
Fax    
Email  Profplal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Binit Sharma 
Designation  Post graduate trainee 
Affiliation  Maulana Azad medical college  
Address  2, Bahadur shah Zafar marg, MAMC Campus,New Delhi, Delhi-110002
2, Bahadur shah Zafar marg, New Delhi, Delhi-110002
Central
DELHI
110002
India 
Phone  7003613007  
Fax    
Email  Sharma.binit2013@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College  
 
Primary Sponsor  
Name  Binit Sharma 
Address  2, Bahadur shah Zafar marg, MAMC Campus, New Delhi-110002 
Type of Sponsor  Other [Self] 
 
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 Binit Sharma   Lok Nayak Hospital   2, Bahadur shah Zafar marg, New Delhi, Delhi-110002 surgery department
Central
DELHI 		 7003613007

Sharma.binit2013@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, MAMC  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  laparoscopic intraperitoneal onlay mesh (IPOM) plus repair for ventral hernia  operative procedures in which we go into the peritoneal cavity and mesh is placed on inner surface of peritoneum 
Intervention  Extended view totally extraperitoneal Rives Stoppa (e-TEP RS) repair for ventral hernia  operative procedure in which retrorectus space is used for mesh placement. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  All cases of midline ventral hernia(M2,M3) in central or lower abdomen between age 18-75 years  
 
ExclusionCriteria 
Details  1. Patients with defect size > 6cm
2. Recurrent Hernias
3. Emergency cases
4. Hernia with skin infections and enterocutaneous fistula
5. Unfit for General Anaesthesia
6. BMI more than 35 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Operative time defined from incision to last stitch between e-TEP RS versus IPOM plus  Duration of operation defined from incision to last stitch between e-TEP RS versus IPOM plus 
 
Secondary Outcome  
Outcome  TimePoints 
1. Postoperative pain using VAS score at 1day, 1week, 6 week postop
2. Duration of hospital stay(Days)
3. Return to work(Days) 		 Vas score at 1 day, 1 week, 6 week 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/03/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  MAMC Library

  6. For how long will this data be available start date provided 18-01-2024 and end date provided 18-12-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Primary and incisional ventral hernias repairs have always been a challenge for surgeons. In the current era, so many different options for the management of these hernias are available from various open to minimal invasive techniques, and this diversity of techniques makes the decision making more difficult in ventral hernia. Surgeons are still in a search of the ideal or standardized method that adequately decreases postoperative complications and improves quality of life. According to latest evidence, laparoscopic techniques have the advantage of shorter hospital stay after surgery, early resumption of work, and lesser surgical wound complications as compared to open techniques. From IPOM to e-TEP, minimal invasive procedures for ventral hernia repair with different techniques and mesh positions have evolved rapidly in the last decade. e-TEP offers the benefit of a minimally invasive procedure along with mesh in sublay/retrorectus position, hence avoiding the intra-abdominal mesh-related complications. .Another advantage of e-TEP in large ventral hernia is that if closure is difficult or not possible, then posterior component separation technique in the form of transversus abdominis release can be combined as the plane of dissection is the same. As per available evidence, it is believed that mesh in sublay position offers superior quality of postoperative connective tissue formation, less recurrence, and less cost as compared to composite mesh with anti-adhesion barrier used for intra-peritoneal position. The current data are lacking, as till now only one retrospective comparative study by Penchev et al. of both the approaches has been published. 
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