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CTRI Number  CTRI/2023/10/059324 [Registered on: 31/10/2023] Trial Registered Prospectively
Last Modified On: 30/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Randomized Controlled Study comparing 2 types of laparoscopic hernia repair of abdominal wall i.e TARM and eTEP-RS, chiefly the time required to complete the operation and the severity of post-operative pain among the two. 
Scientific Title of Study   Comparison of Laparoscopic Transabdominal Retromuscular (TARM) Repair with extended view Totally Extraperitoneal – Rives Stoppa (eTEP-RS) Repair for Ventral Hernias - a Randomized Controlled Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sourav Dhar 
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, MAMC Campus, New Delhi, Delhi-110002
Central
DELHI
110002
India 
Phone  7087081991  
Fax    
Email  sourav982009@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pawanindra Lal 
Designation  Head of Department 
Affiliation  Maulana Azad Medical College 
Address  Room 202, 2nd Floor, Department of Surgery, BLT Block, 2, Bahadur Shah Zafar Marg, MAMC Campus, New Delhi, Delhi-110002
Room 202, 2nd Floor, Department of Surgery, BLT Block, 2, Bahadur Shah Zafar Marg, MAMC Campus, New Delhi, Delhi-110002
Central
DELHI
110002
India 
Phone  9891209609  
Fax    
Email  profplal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sourav Dhar 
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, MAMC Campus, New Delhi, Delhi-110002
Central
DELHI
110002
India 
Phone  7087081991  
Fax    
Email  sourav982009@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College 
 
Primary Sponsor  
Name  Maulana Azad Medical College and Lok Nayak Hospital 
Address  Maulana Azad Medical College, 2, Bahadur Shah Zafar Marg, Near Delhi Gate, New Delhi - 110002 
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 Sourav Dhar  Lok Nayak Hospital  Department of General Surgery, 2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi, 110002
Central
DELHI 		 9891209609

sourav982009@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College  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  Extended view Totally Extraperitoneal-Rives Stoppa (eTEP-RS) Repair  eTEP-RS is another technique for laparoscopic ventral hernia repair, duration of intervention roughly 1.5 hours. Here retrorectus space is created through extraperitoneal approach by telescopic dissection between the rectus muscle and posterior rectus sheath; for supra-umbilical/epigastric defects, dissection begins in right lower retrorectus space through the infraumbilical port. For umbilical and infraumbilical defects, dissection of retrorectus space begins in left upper quadrant. Hernial contents are reduced, polypropylene mesh is placed in the retrorectus space usually without fixation and gas is deflated slowly under vision. 
Intervention  Transabdominal Retromuscular (TARM) Repair  TARM is a novel technique for laparoscopic ventral hernia repair (supra-umbilical/infra-umbilical, lateral hernias), duration of intervention roughly being 2 hours. Here retrorectus space is created through intraperitoneal approach by separating a flap consisting of peritoneum and posterior rectus sheath; the content is reduced and a polypropylene mesh is placed in the space created. Conventionally 3 ports are used - upper abdominal for infra-umbilical and lower abdominal for supra-umbilical hernias. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients aged 18-65 years with primary midline ventral hernia, presenting to surgery OPD of Lok Nayak Hospital planned for laparoscopic hernia repair. 
 
ExclusionCriteria 
Details  1. Patients with defect size >6 cm
2. Recurrent hernias
3. Obstructed or strangulated (complicated) hernia
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Operative time defined from first incision to last stitch between TARM versus e-TEP RS, recorded in minutes.   operative time assessed immediately at the end of surgery when the last stitch is placed. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Postoperative pain using VAS score at 24 hours, 72 hours & 7 days post-operatively.
2. Duration of hospital stay(Days)
3. Return to work(Days) 		 VAS score at 24 hours, 72 hours & 7 days post-operatively.  
 
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   Phase 4 
Date of First Enrollment (India)   10/11/2023 
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   N/A 
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 18-04-2024 and end date provided 18-03-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Purpose of the protocol - to compare the key differences between two types of Laparoscopic Hernia repair i.e. Transabdominal Retromuscular Repair (TARM) and Extended view Totally Extraperitoneal Rives Stoppa (eTEP-RS) Repair, primarily comparing operative time between the two approaches. The secondary outcomes being considered are - post-operative pain as VAS score at 24hr, 72hr and 7 days post-operatively, duration of hospital stay (in days) and days until return to work/daily routine. The study is being conducted to establish the benefits and disadvantages of approaching the retrorectus plane transabdominally i.e. after breaching the peritoneum versus creating the plane while working extraperitoneally. 
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