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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  
Name  Address 
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 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  
Status 
Not Applicable 
 
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  

A hernia is the abnormal protrusion of an organ or tissue through a defect in the surrounding wall, most commonly seen in the inguinal region. Inguinal herniorrhaphy is one of the most frequently performed operations by general surgeons. With the rise of minimally invasive surgery, laparoscopic hernia repair has become widely practiced and is considered the preferred approach for bilateral and recurrent inguinal hernias. The two main laparoscopic techniques are transabdominal preperitoneal repair described in 1992 and totally extraperitoneal repair described in 1993. The TAPP procedure is easier to learn but requires entry into the peritoneal cavity, making mesh fixation and peritoneal closure a technical challenge.

Various methods exist for peritoneal closure in TAPP including tackers, staples, fibrin glue, and sutures. The choice depends on surgeon skill, institutional practices, postoperative pain outcomes, and cost. Tackers may increase cost and cause persistent groin pain, fibrin glue is painless but expensive, and sutures are cost effective but require advanced laparoscopic skills and increase operative time. The introduction of 3D 4K imaging has improved laparoscopic suturing, reducing operating time and enhancing depth perception.

TAPP repair performed by experienced surgeons is safe with recurrence rates similar to open surgery. Complication rates range between 2.5 and 27 percent, with common issues including postoperative pain, seroma, and recurrence, and rare cases of bowel obstruction. Peritoneal closure remains a key step since tackers can cause adhesions and suture knots may fail leading to herniation.

This study aims to compare two peritoneal closure techniques in TAPP repair focusing on postoperative pain, operative duration, and long term complications.

 
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