| CTRI Number |
CTRI/2025/11/098026 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
19/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
STUDY OF TWO DIFFERENT WAYS OF SEALING THE ABDOMINAL LINING IN HERNIA REPAIR |
|
Scientific Title of Study
|
COMPARISON OF ABSORBABLE TACKERS VERSUS UNIDIRECTIONAL BARBED ABSORBABLE SUTURES FOR CLOSING PERITONEAL FLAP IN TRANS ABDOMINAL PRE-PERITONEAL HERNIA REPAIRS:
A RANDOMISED CONTROLLED 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 |
DR SAYANDEEP SAHA |
| Designation |
RESIDENT |
| Affiliation |
ARMED FORCES MEDICAL COLLEGE |
| Address |
DEPARTMENT OF GENERAL SURGERY, ARMED FORCES MEDICAL COLLEGE, PUNE, MAHARASHTRA
Pune MAHARASHTRA 411040 India |
| Phone |
9205673538 |
| Fax |
|
| Email |
drsayandeepsaha@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR ANIMESH VATSA |
| Designation |
PROFESSOR (GENERAL SURGERY) |
| Affiliation |
ARMED FORCES MEDICAL COLLEGE |
| Address |
DEPARTMENT OF GENERAL SURGERY, ARMED FORCES MEDICAL COLLEGE, PUNE, MAHARASHTRA
Pune MAHARASHTRA 411040 India |
| Phone |
9560495765 |
| Fax |
|
| Email |
animeshvats@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
DR ANIMESH VATSA |
| Designation |
PROFESSOR (GENERAL SURGERY) |
| Affiliation |
ARMED FORCES MEDICAL COLLEGE |
| Address |
DEPARTMENT OF GENERAL SURGERY, ARMED FORCES MEDICAL COLLEGE, PUNE, MAHARASHTRA
Pune MAHARASHTRA 411040 India |
| Phone |
9560495765 |
| Fax |
|
| Email |
animeshvats@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College, Pune, 411040, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical College |
| Address |
Pune, 411040, Maharashtra, India |
| 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 ANIMESH VATSA |
ARMED FORCES MEDICAL COLLEGE , PUNE |
DEPARTMENT OF GENERAL SURGERY, ARMED FORCES MEDICAL COLLEGE, PUNE, MAHARASHTRA Pune MAHARASHTRA |
9560495765
animeshvats@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical Research Cell and Institutional Ethical Committee, Armed Forces Medical College, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ABSORBABLE TACKER |
ABSORBABLE TACKERS WILL BE USED IN PERITONEUM CLOSURE IN TAPP SURGERY |
| Intervention |
BARBED SUTURE FOR PERITONEAL CLOSURE |
IN TAPP SURGERY PERITONEUM IS CLOSED WITH BARBED SUTURE . 20 PDS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a. Patients between 18-65 yrs undergoing unilateral or bilateral Laparoscopic TAPP hernia repair.
b. Written informed consent.
|
|
| ExclusionCriteria |
| Details |
a. Patients with history of recurrence.
c. Patients with comorbidities- smokers, bronchial asthma, on steroid or immunosuppressive therapies.
d. Patients unfit for general anaesthesia or ASA more than III
e. Patients unwilling for regular follow up
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare post operative pain following TAPP (VAS score) at 1, 3 , 7 , 30 days and 6 months. |
1, 3 , 7 , 30 days and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Operative time
• Seroma formation
• Recurrence rates at 6 months
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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 4 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="0" 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
|
|