| CTRI Number |
CTRI/2025/10/096195 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
finding out whether fixing a surgical mesh with stitches or just placing it without stitches during keyhole hernia surgery makes a difference in long-term pain for patients. |
|
Scientific Title of Study
|
Comparative analysis of chronic postoperative inguinal pain between mesh fixation and non-fixation of 3-dimensional polypropylene mesh in patients undergoing laparoscopic transabdominal preperitoneal inguinal hernia repair for unilateral inguinal hernias: A Randomized Controlled Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saurabh Borgharia |
| Designation |
Professor, Dept. of Surgery |
| Affiliation |
Lady Hardinge Medical College |
| Address |
room no 306, dept of general suregry, Lady Hardinge Medical College & Associated Hospitals, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9810203804 |
| Fax |
|
| Email |
saurabhborgharia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashas M |
| Designation |
1st Year PG Resident, Dept. of Surgery |
| Affiliation |
Lady Hardinge Medical College |
| Address |
4th floor wing 1, IPD Building, Dept of general surgery, Lady Hardinge Medical College & Associated Hospitals, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
7019345832 |
| Fax |
|
| Email |
yashasmry123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yashas M |
| Designation |
1st Year PG Resident, Dept. of Surgery |
| Affiliation |
Lady Hardinge Medical College |
| Address |
4th floor, wing 1 IPD building, Dept of general surgery, Lady Hardinge Medical College & Associated Hospitals, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
7019345832 |
| Fax |
|
| Email |
yashasmry123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College, shaheed bhagat singh marg, new dhelhi 110001 |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College Associated Hospitals New Delhi |
| Address |
Lady Hardinge Medical College & Associated Hospitals, Shaheed Bhagat Singh Marg, New Delhi |
| 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 |
| DrYashas M |
Lady Hardinge Medical College & SSK Hospital, New Delhi. |
Dept of Surgery, LHMC
New Delhi
DELHI |
7019345832
yashasmry123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, LHMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A (Fixation) |
Laparoscopic TAPP is done in these patients with 15 × 10 cm 3D polypropylene mesh fixed using absorbable tackers or sutures. |
| Intervention |
Group B (Non-Fixation) |
Laparoscopic TAPP is done o=in these patients with 15 × 10 cm 3D polypropylene mesh placed without fixation with sutures or tackers. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Primary unilateral reducible inguinal hernia |
|
| ExclusionCriteria |
| Details |
Prior lower abdominal surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of chronic postoperative inguinal pain |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Early hernia recurrence diagnosed clinically and radiologically |
3 months |
| Early postoperative pain |
1 week |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
30/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="10" |
|
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
|
This is a randomized controlled trial evaluating the impact of mesh fixation versus non fixation in laparoscopic transabdominal preperitoneal TAPP inguinal hernia repair for primary unilateral hernias The primary endpoint is chronic postoperative inguinal pain at 3 months assessed using Visual Analog Scale VAS score Secondary outcomes include recurrence early postoperative pain and complications such as seroma hematoma and postoperative ileus A total of 64 adult patients will be randomized in a 1 to 1 ratio The trial will be conducted at Lady Hardinge Medical College and Associated Hospitals New Delhi over 14 months from September 2025 to November 2026 |