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CTRI Number  CTRI/2021/06/034287 [Registered on: 17/06/2021] Trial Registered Prospectively
Last Modified On: 30/04/2023
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 Comparison Between Open and Laparoscopic Repair of Uncomplicated Ventral Hernia Using Disease Specific Quality of Life Index 
Scientific Title of Study   Comparison of Open Vs Laparoscopic Repair of Uncomplicated Ventral Hernia Using Disease Specific Quality Of Life Index 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DEEPAK KUMAR 
Designation  Post Graduate - Junior Resident 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR 
Address  Department of General Surgery, 4th Floor, D-Block, All India Institute of Medical Sciences Raipur, Tatibandh, G.E. Road, Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  7085320541  
Fax    
Email  kdeepak2061996@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tridip Dutta Baruah 
Designation  Associate Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR 
Address  Department of General Surgery, 4th Floor, D Block, AIIMS RAIPUR, Tatibandh, G.E. Road, Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9109720246  
Fax    
Email  tridipduttabaruah@gmail.com  
 
Details of Contact Person
Public Query  
Name  DEEPAK KUMAR 
Designation  Post Graduate - Junior Resident 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR 
Address  Department of General Surgery, 4th Floor, D Block, AIIMS RAIPUR, TATIBANDH , G.E. ROAD

Raipur
CHHATTISGARH
492099
India 
Phone  7085320541  
Fax    
Email  kdeepak2061996@gmail.com  
 
Source of Monetary or Material Support  
Department of General Surgery, AIIMS Raipur 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Raipur 
Address  Department of General Surgery, AIIMS Raipur, Tatibandh, Raipur, Chhattisgarh 492099 
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 
Deepak Kumar  All India Institute of Medical Sciences Raipur  Department of General Surgery, D Block,AIIMS Raipur, Tatibandh, Raipur, Chhattisgarh 492099
Raipur
CHHATTISGARH 		 7085320541

kdeepak2061996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC- AIIMS Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K439||Ventral hernia without obstructionor gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Laparoscopic Repair of Ventral Hernia  For the laparoscopic repair of ventral hernia, intraperitoneal access will be gained using either the open Hasson technique or the Veress needle technique. Once pneumoperitoneum is achieved, three to four trocars would be placed usually consisting of one 10-mm port and two to three 5-mm ports. A piece of mesh will then be chosen and cut to allow for a 3 to 5-cm overlap around the fascial defect. The mesh will then be introduced into the peritoneal cavity and anchored to the abdominal wall using tacks ( fixation device). 
Comparator Agent  Open Repair of Ventral Hernia  The open repair of ventral hernia will be performed directly over the hernia site. Using electrocautery the hernia and surrounding fascia will be appropriately exposed. The hernia sac will then be reduced and, depending on the fascial defect size, closed using mesh. Mesh will be primarily placed in an underlay fashion. Other options included onlay, inlay or sublay. The mesh will be secured to the fascia using Prolene sutures in either a running or simple interrupted suture. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  i. Age 18-60 years
ii. Patient give informed written consent
iii. Ventral hernia less than 10cm in diameter
iv. Undergoing elective surgery for ventral hernia 
 
ExclusionCriteria 
Details  i. Pregnant women
ii. Patients with complicated ventral hernia (pain, incarcerated, strangulated etc)
iii. Patients with multiple abdominal scars
iv. Patients with abdominal wall infection
v. Patients with cirrhosis of liver and/or ascites and other co-morbid conditions
vi. Patients on immunosuppressive agents or suffering from immunosuppressive
disorders
vii. History of connective tissue disorder (e.g.: Rheumatoid arthritis,
Scleroderma, Sjogren syndrome, Lupus erythematosus etc ) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Laparoscopic ventral hernia repair improves quality-of-life as compared to open repair
postoperatively. 		 2 month follow up for each patients postoperatively.
Total duration of study is 12 to 18 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Laparoscopic ventral hernia repair also improves the following parameter as compared to
open repair postoperatively.

1. Operative time
2. Postoperative pain by Visual Analogue Scale (VAS)
3. Postoperative analgesia requirement.
4. Postoperative day of mobilisation from bed
5. Postoperative day of discharged
6. Complications 		 2 month follow up for each patients postoperatively.
Total duration of study is 12 to 18 months. 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   20/06/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
After taking written informed consent with patients satisfying
inclusion criteria, the patient’s data like patient’s details, history & examination finding ,
values of routine laboratory investigations and preoperative HerQLes score will be recorded
in the Case Record Performa (CRF). The patients will be allocated randomly into one of the
two groups, Group A (Open Repair) and B (Laparoscopic Repair). Pre operatively patients
will be administered a single dose antibiotic prophylaxis of Ceftriaxone intravenous 1 gm, one
hour before surgery. The patients will be administered Intra-Venous Paracetamol (1gm) at
q8hr and Intra-Venous Diclofenac (Aq) 75 mg at q12hr on the immediate postoperative
period (POD-0). They will be switched to Tablet Diclofenac 50mg PO q8hr from POD1
onwards. The number of days of requirement of Tablet Diclofenac 50mg PO q8hr or any
other additional analgesia requirement will be noted down. Visual Analogue Scale (VAS)
for pain will be recorded at 24 hours postoperatively. The patients will be followed up at
POD7 (1st week) ,4th week and 8th week in the General Surgery Outpatient Department
(OPD) as well as over telephone, for recording HerQLes score for Quality of Life
postoperatively, VAS score for pain/discomfort and for development of any complications
like Seroma, Surgical Site Infection, and Recurrence etc.
 
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