| CTRI Number |
CTRI/2025/04/084321 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
06/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [HERNIA MESH ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Reducing pain after hernia surgery: Comparing two type of meshes |
|
Scientific Title of Study
|
To compare self-fixating polypropylene mesh versus 3D anatomical polypropylene mesh in laparoscopic trans abdominal preperitoneal hernioplasty:
A Randomized Controlled trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Jarapala Venu Madhav |
| Designation |
Senior Resident |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Department of Surgical Disciplines
Minimal access and general surgery
New Delhi
DELHI
110029
India |
| Phone |
9603108543 |
| Fax |
|
| Email |
madhavv695@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Chumber |
| Designation |
PROFESSOR and HOD |
| Affiliation |
Aiims New Delhi |
| Address |
Dept of Surgical Disciplines
Aiims New Delhi
4th Floor Surgery Block
Dept of Surgical Disciplines
Aiims New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9871060404 |
| Fax |
|
| Email |
sunil_chumber@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemanga Kumar Bhattacharjee |
| Designation |
Profesor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Department of Surgical Disciplines
New Delhi
DELHI
110029
India |
| Phone |
7838621562 |
| Fax |
|
| Email |
dr_hkb75@yahoo.com |
|
|
Source of Monetary or Material Support
|
| The cost will be borne by AIIMS, New Delhi research section under an institutional grant. All India institute of medical sciences New Delhi
110029 |
|
|
Primary Sponsor
|
| Name |
Aiims New Delhi |
| Address |
Aiims New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Venu Madhav |
Aiims New Delhi |
4th Floor Surgery Block
Dept of Surgical Disciplines
Aiims New Delhi
New Delhi
DELHI |
9603108543
madhavv695@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee AIIMS New Delhi |
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 |
3D anatomical polypropylene mesh |
3D anatomical polypropylene mesh will be placed in standard TAPP hernioplasty. |
| Intervention |
Self-fixating mesh
|
Self fixating mesh will be placed in standard TAPP hernioplasty.
Study will be done for 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
Patients with unilateral inguinal hernia planned for elective transabdominal preperitoneal hernioplasty. |
|
| ExclusionCriteria |
| Details |
Irreducible hernia
Intra-operative diagnosis of B/L inguinal hernia
History of lower abdominal surgery
Chronic groin pain
Chronic analgesics abuser
Any concomitant procedure planned |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post operative pain at 20-24 hrs following surgery in terms of Visual analogue scale (VAS).
|
20-24 hrs following surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mesh deployment time
|
Intraoperative |
| Surgeons satisfaction score |
intraoperative |
| chronic pain and recurrence |
3 months |
| Quality of life of the patients |
3 months |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
21/04/2025 |
| 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="8"
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
|
Inguinal hernia is one of the most common problems in the surgical patients. Various types of meshes are used for the repair of inguinal hernia. In this study, the use of 3D anatomical mesh with tacker fixation, provide structural support but may lead to issues related to mesh fixation. Self-grip mesh, by adhering directly to tissue without tackers, offers a potentially beneficial alternative like less post operative pain. We propose this randomised trial to compare self-fixating mesh and 3D anatomical mesh. |