| CTRI Number |
CTRI/2026/02/103051 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Two Minimally Invasive Surgical Methods for Umbilical and Para-Umbilical Hernia Repair |
|
Scientific Title of Study
|
A randomised control trial study of comparison between IPOM vs e TEP in Laparoscopic in umbilical and para-umbilical hernia |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krunalkumar Jivrambhai Patel |
| Designation |
General Surgery Resident |
| Affiliation |
Government medical College Bhavnagar |
| Address |
Department of General Surgery Sir T Hospital Jail Road Kalanala Bhavnagar
Department of General Surgery Sir T Hospital Jail Road Kalanala Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9512433452 |
| Fax |
|
| Email |
Krunal35patel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Firdaus A Dekhaiya |
| Designation |
Associate Professor |
| Affiliation |
Government medical college Bhavanagar |
| Address |
Department of General surgery sir t hospital bhavanagar
District jail road bhavanagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9825133976 |
| Fax |
|
| Email |
drfirdausd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr krunal Kumar jivarambhai patel |
| Designation |
General surgery resident |
| Affiliation |
Government medical college Bhavanagar |
| Address |
Department of General surgery sir t hospital bhavanagar
District jail road bhavanagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9512433452 |
| Fax |
|
| Email |
krunal35patel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical College Bhavnagar pin 364001 Gujarat India |
|
|
Primary Sponsor
|
| Name |
Government medical College bhavanagar |
| Address |
Near st bus stand Jail road kalanala Bhavnagar 364001 Gujarat |
| 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 Krunalkumar Patel |
Sir t hospital bhavanagar |
Department of general surgery government medical College and Sir T Hospital Jail road Bhavnagar
Bhavnagar
GUJARAT |
9512433452
Krunal35patel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K429||Umbilical hernia without obstruction or gangrene, (2) ICD-10 Condition: K439||Ventral hernia without obstructionor gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ipom and etep |
comparison of outcomes between laparoscopic ETEP enhanced view totally extraperitoneal and IPOM intraperitoneal onlay mesh techniques in the repair of umbilical paraumbilical ventral hernias |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients with umbilical and para umbilical hernias eligible for laparoscopic surgery
|
|
| ExclusionCriteria |
| Details |
Patients who were offered open surgeries for the same.
Surgeries converted to open
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the hospital stay between ETEP and IPOM surgery in umbilical and paraumbilical hernia
To compare the duration of surgery between ETEP and IPOM surgery in umbilical and paraumbilical hernia
To compare the Post/ intra operative complication in terms of of Recurrence of hernia, intra op bleeding, intra op conversion to open, difficulty in dissection , pain, hematoma, hemorrage,Mesh infection , surgical site infection between ETEP and IPOM surgery in umbilical and paraumbilical hernia
|
6 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to obtain the various outcome of ipom and etep |
6 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
16/02/2026 |
| 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)
|
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
|
Umbilical and paraumblical hernia occurs as a result of weakness in musculofascial layer of anterior abdominal wall The most important causes are congenital acquired incisional and traumatic Umbilical and paraumblical can be repair by laproscopic surgical procedure A successful series of laparoscopic repair of umbilical hernia and paraumblical hernia was done Open sublay technique and laparoscopic intraperitoneal onlay mesh IPOM technique are the most common used procedures in ventral and incisional hernia repair however each technique has its own disadvantages The enhanced view total extraperitoneal technique ETEP aims to put the mesh in the retromuscular space by minimal invasive technique This study is to investigate the outcome of ETEP and IPOM approach in umbilical and paraumbilical hernia repair |