| CTRI Number |
CTRI/2025/03/082172 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| 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 study comparing results of mesh placement in umbilical hernia surgery in 2 different planes of abdomen with one group mesh placed above abdominal wall muscle and other between the layers of abdominal wall muscle |
|
Scientific Title of Study
|
A Comparative study of outcomes of onlay and retro rectus mesh repair in the management of umbilical hernia Randomised control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Archana N |
| Designation |
PG student |
| Affiliation |
Bangalore medical college and research institute Karnataka |
| Address |
Department of General surgery,Victoria hospital ,Bangalore medical and research institute
Bangalore
KARNATAKA
560018
India |
| Phone |
8892356976 |
| Fax |
|
| Email |
archn567@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kemparaj T |
| Designation |
Professor |
| Affiliation |
Bangalore medical college and research institute Karnataka |
| Address |
Department of General surgery,Victoria hospital, Bangalore medical college and research institute
Bangalore
KARNATAKA
560002
India |
| Phone |
9448455040 |
| Fax |
|
| Email |
dkemprajt@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kemparaj T |
| Designation |
PROFESSOR |
| Affiliation |
Bangalore medical college and research institute Karnataka |
| Address |
Department of General surgery ,Victoria hospital ,Bangalore medical college and research institute
Bangalore
KARNATAKA
560002
India |
| Phone |
9448455040 |
| Fax |
|
| Email |
dkemprajt@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Department of General surgery Victoria hospital BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE , fort,Krishna Rajendra road Bangalore Karnataka 560002 india |
|
|
Primary Sponsor
|
| Name |
Bangalore medical College and research institute |
| Address |
Department of General Surgery,Victoria hospital,Bangalore medical college and research institute Fort, Krishna Rajendra road Bangalore Karnataka 560002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| 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 Archana N |
Bangalore medical college and research institute |
Department of General surgery,Victoria hospital,Bangalore medical college and research institute, Victoria hospital , Fort, Krishna Rajendra road 560002
Bangalore
KARNATAKA |
8892356976
archn567@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| bangalore medical college and research institue |
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: K429||Umbilical hernia without obstruction or gangrene, (3) ICD-10 Condition: K429||Umbilical hernia without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
RETRORECTUS MESH REPAIR in umbilical hernia |
Mesh is placed in retro rectus plane between rectus muscle and posterior rectus sheath for umbilical hernia |
| Intervention |
Onlay mesh repair in umbilical hernia |
mesh placed above the rectus sheath in onlay mesh repair for umbilical hernia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with umbilical hernia
Patients giving informed consent |
|
| ExclusionCriteria |
| Details |
Patient not giving consent
Divarication of recti
Recurrent umbilical hernia |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
POST OPERATIVE PAIN
|
Post operative day 1,2,3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SURGICAL SITE INFECTION
POSTOPERATIVE HOSPITAL STAY |
POST OPERATIVE DAY 3 & 5
Those staying less than 3 days or those staying more than 3 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
23/03/2025 |
| 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 Applicable |
| 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 hernia is protrusion of viscus or part of viscus through a defect in anterior abdominal wall in the umbilical region ,there are various treatment modalities for umbilical hernia such as in lay mesh , retro rectus mesh repair, preperitoneal mesh repair, IPOM. Retro rectus mesh repair is better than Onlay mesh repair. onlay repair has more complications such as surgical site infection , increased duration of hospital stay, more post op pain compared to retro rectus mesh repair. studies have shown that retro rectus mesh repair has better outcomes than onlay meh repair, hence my study aims to prove the same |