| CTRI Number |
CTRI/2024/11/077242 [Registered on: 22/11/2024] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinicl study comparing two laparoscopic surgical procedures (eTEP vs IPOM) for abdominal hernia repair. |
|
Scientific Title of Study
|
Randomised control trial comparing eTEP (extended totally extraperitoneal repair) vs IPOM (intraperitoneal onlay mesh) for ventral hernia repair. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saptarshi Mondal |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences, Patna |
| Address |
Room 425, 4th Floor, Ward Block, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna 800014
Patna
BIHAR
800014
India |
| Phone |
8697483430 |
| Fax |
|
| Email |
withsaptarshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prem Prakash |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences, Patna |
| Address |
Room 438, 4th Floor, Ward Block, Indira Gandhi Institute of Medical Sciences, Patna-800014
Patna
BIHAR
800014
India |
| Phone |
9801276237 |
| Fax |
|
| Email |
drpremprakash01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saptarshi Mondal |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences, Patna |
| Address |
Room 425,
4th Floor, Ward Block, Indira Gandhi Institute of Medical Sciences, Patna-800014
Patna
BIHAR
800014
India |
| Phone |
8697483430 |
| Fax |
|
| Email |
withsaptarshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences Patna-800014, Bihar, India |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Institute of Medical Sciences |
| Address |
Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna-800014 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saptarshi Mondal |
Indira Gandhi Institute of Medical Sciences, Patna |
Room 425, 4th floor, Ward Block, Department of General Surgery, Sheikhpura, Patna 800014
Patna
BIHAR |
8697483430
withsaptarshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Extended totally extraperitoneal repair (ETEP) |
In this method a large surgical space is created in the extraperitoneal space without entering the abdominal cavity and mesh placed within it and will be conducted over a period of 2 years. |
| Comparator Agent |
Intraperitoneal onlay mesh (IPOM) |
It involves bridging the hernial defect from the peritoneal side with a mesh which will be conducted over a period of 2 years. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patient above and including 18yrs of age.
2. Primary ventral or incisional hernia defect.
3. Hernia defect size greater than or equal to 2cm and lesser than or equal to 7cm.
4. Patient fit to tolerate General Anesthesia.
5. Patient eligible for repair via manual invasive procedure.
Should be able to give consent to participate in trial.
|
|
| ExclusionCriteria |
| Details |
1. Hernia defect size more than 7cm and less than 2cm
2. Hernia defect require open surgical approach.
3. Recurrent hernia after repair by recto-rectus mesh placement.
4. Patient not willing to give consent.
5. Patient not fit for general anesthesia.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain score on Post-operative Day 1 measured using Visual Analogue Scale. |
Day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain in post-operative period measured on follow-up at Day 30 & Day 90 using Visual Analogue Scale. |
Day 30 & 90 |
| Wound events such as surgical site infection (SSI) & surgical site occurrences requiring procedural intervention. |
Till day 180 |
| Abdominal wall-specific quality of life measured using Hernia-related quality of life survey |
Day 180 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
07/12/2024 |
| 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="2"
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 - NO
|
|
Brief Summary
|
Title:
RANDOMISED CONTROL TRIAL COMPARING ETEP (EXTENDED TOTALLY EXTRAPERITONEAL REPAIR) VERSUS IPOM (INTRAPERITONEAL ONLAY MESH) FOR VENTRAL HERNIA REPAIR.
Introduction:
Ventral hernia repair still remains a significant challenge in surgery, with laparoscopic techniques having greatly evolved over time. IPOM and eTEP are two promising methods for hernia repair.
Aims:
To investigate the efficacy and safety of eTEP and IPOM approach in ventral hernia repair.
Objectives:
Primary objective is to compare immediate post-operative pain scores on POD1 (using VAS).
Secondary objectives is comparison of postoperative pain on Day 30 and 90, quality of life and other surgical site occurrences.
Methodology:
A single centre randomised control trial of duration one year will be conducted on 40 patients undergoing uncomplicated ventral hernia repair, having abdominal wall defect size within 2 to 7 cm, where 20 patients will be assigned to each IPOM and eTEP study groups.
|