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CTRI Number  CTRI/2022/04/041759 [Registered on: 08/04/2022] Trial Registered Prospectively
Last Modified On: 05/04/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   RANDOMISED CONTROLLED STUDY TO COMPARE INTRAPERITONEAL ONLAY MESH PLUS REPAIR VERSUS TRANSABDOMINAL PRE PERITONEAL MESH PLUS REPAIR FOR PATIENT WITH VENTRAL HERNIA 
Scientific Title of Study   A PROSPECTIVE, RANDOMISED CONTROLLED STUDY TO COMPARE INTRAPERITONEAL ONLAY MESH PLUS REPAIR VERSUS TRANSABDOMINAL PRE PERITONEAL MESH PLUS REPAIR FOR PATIENT WITH VENTRAL HERNIA 
Trial Acronym  IPOM PLUS VERSUS TAPP PLUS TRIAL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Devender Singh 
Designation  Assistant Professor 
Affiliation  ESIC MEDICAL COLLEGE AND HOSPITAL 
Address  Room No.2, 3 rd Floor, Department of Surgery, ESIC Medical College and Hospital, Faridabad

Faridabad
HARYANA
121001
India 
Phone  09813643337  
Fax    
Email  devinderkuntal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Devender Singh 
Designation  Assistant Professor 
Affiliation  ESIC MEDICAL COLLEGE AND HOSPITAL 
Address  Room No.2, 3 rd Floor, Department of Surgery, ESIC Medical College and Hospital, Faridabad

Faridabad
HARYANA
121001
India 
Phone  09813643337  
Fax    
Email  devinderkuntal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Devender Singh 
Designation  Assistant Professor 
Affiliation  ESIC MEDICAL COLLEGE AND HOSPITAL 
Address  Room No.2, 3 rd Floor, Department of Surgery, ESIC Medical College and Hospital, Faridabad

Faridabad
HARYANA
121001
India 
Phone  09813643337  
Fax    
Email  devinderkuntal@gmail.com  
 
Source of Monetary or Material Support  
ESIC Medical College and Hospital, New Industrial Town, Faridabad, Haryana. PIN No. 121001 
 
Primary Sponsor  
Name  ESIC Medical College and Hospital Faridabad 
Address  NIT, FARIDABAD, PIN NO. 121001 
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 Devender Singh  ESIC Medical College and Hospital   Room no.2, 3 rd Floor, Department of Surgery
Faridabad
HARYANA 		 09813643337

devinderkuntal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical commiittee  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: O||Medical and Surgical, (3) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Laparoscopic IPOM PLUS in one arm Laparoscopic TAPP PLUS in other arm  IN IPOM PLUS GROUP MESH WILL BE INTRAPERITONEAL AND IN TAPP PLUS MESH WILL BE EXTRAPERITONEAL AND COMPARATIVE RESULTS WILL BE ASSESED AT 12 MONTHS BETWEEN THE TWO GROUPS 
Comparator Agent  Laparoscopic IPOM Plus mesh hernia repair  IN IPOM PLUS GROUP COMPOSITE MESH WILL BE PLACED INTRAPERITONEALY AFTER REDUCING THE CONTENTS OF HERNIA AND CLOSING THE DEFECT 
Comparator Agent  Laparoscopic TAPP PLUS Mesh hernia repair  IN TAPP PLUS GROUP PROLENE MESH WILL BE PLACED EXTRAPERITONEALLY AFTER REDUCING THE CONTENTS OF HERNIA AND SUTURING THE DEFECT 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age ≥ 18 years
Ventral hernia (Primary or Incisional)
Defect size 2-8 cm
 
 
ExclusionCriteria 
Details  1. Patients undergoing emergency surgery
2. Parastomal or recurrent hernias
3. Unfit for General anesthesia and Laparoscopy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare postoperative morbidity including the pain scores and seroma rate   6hr, 24hr, 72 hr and than at 7, 30, 90, 180 and 360 days 
 
Secondary Outcome  
Outcome  TimePoints 
To compare length of hospital stay, surgical site infection (SSI), hernia recurrence, mesh infection, cost, operative time and patient quality of life
 		 6hr, 24hr, 72 hr and than at 7, 30, 90, 180 and 360 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/05/2022 
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   NIL 
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 - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [devinderkuntal@gmail.com].

  6. For how long will this data be available start date provided 10-05-2023 and end date provided 10-08-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

        Ventral hernia is the leading cause of abdominal pain, functional impairment and subacute intestinal obstruction. Large comparative studies have shown the advantage of laparoscopic repair over open repair. Conventional laparoscopic repair as popularised by Blanc and Booth in 1993 involves intraperitoneal placement of mesh. Limitation of which includes the requirement of costly composite mesh and fixating device. Also in few cases intraperitoneal mesh may lead to intestinal obstruction and perforation. The current trend among hernia surgeons is to place the mesh extraperitoneally or pre-peritoneally to avoid all the mesh related complications. The only limitation of pre-peritoneal mesh placement is slightly longer operative time and requirement of advanced laparoscopic skills. However there is paucity of literature comparing IPOM with TAPP which is limited to only few retrospective studies. Hence we are planning to conduct this prospective randomised  controlled study to know the advantages of one over another.

 
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