| CTRI Number |
CTRI/2025/09/094395 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Laparoscopic Or Open Intraperitoneal Meshplasty For Small Umbilical Hernia-- Which One Is Better? |
|
Scientific Title of Study
|
A Comparative Study To Evaluate The Efficacy Of Two Minimally Invasive Techniques For Repair Of Small Umbilical Hernias Using Dual Layered Patch Mesh |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Charmi Mistry |
| Designation |
Junior Resident |
| Affiliation |
HBT MEDICAL COLLEGE & DR. R. N. COOPER HOSPITAL |
| Address |
Department of General Surgery,
Juhu, Vile-Parle west, Mumbai.
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
8169081745 |
| Fax |
|
| Email |
drcharmimistry@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vipul Nandu |
| Designation |
Assistant Professor |
| Affiliation |
HBT MEDICAL COLLEGE & DR. R. N. COOPER HOSPITAL |
| Address |
Department Of General Surgery,
Juhu, Vile-Parle West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
7977023286 |
| Fax |
|
| Email |
dr.vipulnandu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vipul Nandu |
| Designation |
Assistant Professor |
| Affiliation |
HBT MEDICAL COLLEGE & DR. R. N. COOPER HOSPITAL |
| Address |
Department Of General Surgery,
Juhu, Vile-Parle West, Mumbai
MAHARASHTRA
400056
India |
| Phone |
7977023286 |
| Fax |
|
| Email |
dr.vipulnandu@gmail.com |
|
|
Source of Monetary or Material Support
|
| HBT Medical College & Dr. R. N. Cooper Hospital, Juhu, Vile-Parle West, Mumbai , Maharashtra, India. Pin code -400056 |
|
|
Primary Sponsor
|
| Name |
HBT Medical College |
| Address |
Juhu, Vile-Parle West, Mumbai |
| 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 Charmi Mistry |
HBT Medical College & Dr. R. N. Cooper Hospital |
Juhu, Vile-Parle West, Mumbai
Mumbai (Suburban)
MAHARASHTRA |
8169081745
drcharmimistry@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEEE |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with umbilical and paraumbilical hernia with defect size less than 3 cm and undergoing elective surgery.
2. Age between 18 to 80 years.
3. Consenting for the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients not consenting for the study.
2. Patients with umbilical/paraumbilical hernia with defect size more than 3 cm
3. Recurrent/ incisional hernias
4. Any other hernia except umbilical and paraumbilical hernias.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare Outcomes Of Patient Undergoing Open V/S Laparoscopic Intraperitoneal Onlay Meshplasty For Umbilical/Paraumbilical Hernias Using Same Dual Layered Composite Circular Mesh |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To Compare Intra-Operative Time & Meshplacement Time During Both The Procedures
2. To Assess Complications With Both Procedures With Respect To Post-Operative Pain, Ssi Rates And Early Recurrence.
|
8 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
We will be conducting a prospective
randomised case-control study at a single urban tertiary care centre,It
involves 60 adult patients, above 18 years with uncomplicated umbilical hernias
scheduled for ipom vs open umbilical hernia both with patch mesh plasty.All
having defect size <3cm
Two groups were assigned randomly :
Group A of 30 patients are operated using laparoscopic ipom technique and Group B 30 patients with open umbilical
hernia repair. To compare outcomes of patients undergoing open intraperitoneal
mesh plasty v/s Laparoscopic intraperitoneal onlay mesh plasty for umbilical/
paraumbilical hernias using the same dual layered Composite circular mesh.To
compare intra-operative time, mesh placement time, and shift out of ot time. Wound healing, post-operative pain, ssi rates, time to
discharge after surgery, early
recurrence We will analyse the data
using Microsoft Excel and SPSS version 21 software. ethical approval and
secured informed consent for participating in case study as well as undergoing
operation will be taken separately .The study aims to provide empirical
evidence regarding the potential advantages of specifically in clinical guidance
,operative time ,reducing complications, improving patient well-being ,assessment
to new advances. |