FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/092517 [Registered on: 06/08/2025] Trial Registered Prospectively
Last Modified On: 05/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study outcome between different mesh fixation techniques in patients undergoing laparoscopic groin hernia surgery. 
Scientific Title of Study   A prospective comparative study between suture fixation of mesh versus tack fixation of mesh in laparoscopic trans-abdominal pre-peritoneal (TAPP) repair of inguinal hernia  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aadit Goel 
Designation  Junior Resident 
Affiliation  Sawai Man Singh Medical College Jaipur 
Address  Room No. 117, First Floor, Surgery Office, Department of General Surgery, Sawai Man Singh Medical College and Hospital Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9671308141  
Fax    
Email  docaadit@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hanuman Ram Khoja 
Designation  Professor 
Affiliation  Sawai Man Singh Medical College Jaipur 
Address  Room no 117, First Floor, Department of General Surgery, Sawai Man Singh Medical College and Hospital Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9460324000  
Fax    
Email  dr.hanumankhoja@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aadit Goel 
Designation  Junior Resident 
Affiliation  Sawai Man Singh Medical College Jaipur 
Address  Room no 117, First Floor, Department of General Surgery, Sawai Man Singh Medical College and Hospital Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9671308141  
Fax    
Email  docaadit@gmail.com  
 
Source of Monetary or Material Support  
Sawai Man Singh Medical College, Jaipur-302004, Rajasthan 
 
Primary Sponsor  
Name  Department of General Surgery Sawai Man Singh Medical College and Hospital 
Address  Room No. 117, First Floor, Department of General Surgery, Sawai Man Singh Medical College and Hospital Jaipur 302004 Rajasthan 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Hanuman Ram Khoja  Sawai Man Singh Medical College and Hospital Jaipur 302004 Rajasthan 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aadit Goel  Sawai Man Singh Medical College and Hospital  Room no 117, First Floor, Department of General Surgery, Sawai Man Singh Medical College and Hospital Jaipur 302004 Rajasthan
Jaipur
RAJASTHAN 		 9671308141

docaadit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, SMS Medical College and Attached Hospitals, Jaipur  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  Suture fixation of mesh  Suture Fixation of mesh using polyglactin 910 suture in laparoscopic trans-abdominal pre-peritoneal repair of inguinal hernia surgery. Patients to be followed for postoperative pain for 3 months. 
Intervention  Tack Fixation of Mesh  Tack Fixation of mesh using Laparoscopic tacker firing in laparoscopic trans-abdominal pre-peritoneal repair of inguinal hernia surgery. Patients to be followed for postoperative pain for 3 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients with reducible inguinal hernia
2. Patients who give written and informed consent to participate in study
3. Patients with no comorbidity that contraindicates general anaesthesia and laparoscopic surgery 
 
ExclusionCriteria 
Details  1. Patients with recurrent, obstructed or strangulated hernias
2. Intra-operative conversion from laparoscopic to open inguinal hernia repair
3. Patients with cardiovascular complications, respiratory complications, contraindication to general anaesthesia and laparoscopic surgery  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Post-operative pain  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 2 
Date of First Enrollment (India)   18/08/2025 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [docaadit@gmail.com].

  6. For how long will this data be available start date provided 01-02-2027 and end date provided 01-02-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This clinical trial is being conducted to compare Tack fixation of mesh versus Suture Fixation of mesh, if any in patients undergoing laparoscopic repair of inguinal hernias by transabdominal preperitoneal approach by evaluating postoperative pain upto three months after surgery. 
Close