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CTRI Number  CTRI/2025/04/084850 [Registered on: 15/04/2025] Trial Registered Prospectively
Last Modified On: 14/04/2025
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   Different methods of mesh fixation in hernia surgery: a comparision of post operative outcomes  
Scientific Title of Study   Comparing Sutures vs. N-hexyl cyanoacrylate glue mesh fixation in reducing postoperative pain in patients undergoing unilateral inguinal hernia repair-A single blinded randomized control trail 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swaroop Johnson Michael 
Designation  Junior Resident 
Affiliation  JIPMER 
Address  Jipmer Campus Rd, Gorimedu, Priyadarshini Nagar, Puducherry, 605006 Old Block, Room 86, Second floor. Jipmer Campus Rd, Gorimedu, Priyadarshini Nagar, Puducherry, 605006 IPD block, 2nd floor, Ward 31

Pondicherry
PONDICHERRY
605006
India 
Phone  09100831537  
Fax    
Email  johnsonmichael831537@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Swaroop Johnson Michael 
Designation  Junior Resident 
Affiliation  JIPMER 
Address  Jipmer Campus Rd, Gorimedu, Priyadarshini Nagar, Puducherry, 605006 Old block, Room 86, Second floor. Jipmer Campus Rd, Gorimedu, Priyadarshini Nagar, Puducherry, 605006 IPD block, 2nd floor, Ward 31

Pondicherry
PONDICHERRY
605006
India 
Phone  09100831537  
Fax    
Email  johnsonmichael831537@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vijaykumar C 
Designation  Associate Professor 
Affiliation  JIPMER 
Address  Jipmer Campus Rd, Gorimedu, Priyadarshini Nagar, Puducherry, 605006. OPD block, second floor, Room 86

Pondicherry
PONDICHERRY
605006
India 
Phone  09100831537  
Fax    
Email  vijaymmc01@gmail.com  
 
Source of Monetary or Material Support  
JIPMER Jipmer Campus Rd, Gorimedu, Priyadarshini Nagar, Puducherry, 605006.  
 
Primary Sponsor  
Name  JIPMER 
Address  JIPMER Jipmer Campus Rd, Gorimedu, Priyadarshini Nagar, Puducherry, 605006.  
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 Swaroop  JIPMER  Jipmer Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006 ROOM NUMBER 86, SECOND FLOOR OLD BUIDLING, OPD BLOCK, DEPARTMENT OF SURGERY.
Pondicherry
PONDICHERRY 		 09100831537

johnsonmichael831537@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES  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 
Intervention  n-hexyl-cyanoacrylate glue   mesh fixation will be done with n-hexyl-2cyanoacrylate gel in this arm  
Comparator Agent  Sutures for mesh fixation   here sutures will be used to fix the mesh in hernia repair.  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All consenting patients with primary elective unilateral uncomplicated inguinal hernia planned for open mesh repair 
 
ExclusionCriteria 
Details  1.Hernia patients with disorders of hemostasis and coagulation
2.Chronic pain due to previously operated opposite side or due to any other medical problem
3.Patient undergoing concomitant surgeries along with mesh repair 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of sutures vs. N-hexyl-cyanoacrylate for mesh fixation in reducing postoperative pain during elective primary unilateral inguinal hernia repair.fixation in reducing postoperative pain during elective primary unilateral inguinal hernia repair.  day 0,1,2,7,30 of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the short-term outcomes (local numb-ness & hematoma, seroma, rate of SSI, urinary reten-tion, length of operation, intraoperative time for mesh fixation, Length of hospital stay & time to return to work) between the two groups
2. To compare the long-term outcomes (Chronic pain, & recurrence) between the two groups
 		 day 0,1,2,7,30, after 6 months & 1year of surgery  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   N/A 
Date of First Enrollment (India)   10/05/2025 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [vijaymmc01@gmail.com].

  6. For how long will this data be available start date provided 01-11-2024 and end date provided 01-07-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is going to be an RCT comparing two efficient methods of mesh fixation in elective hernia repair to compare the outcomes of surgery post operatively. Using sutures and N-hexyl-2cyanoacrylate we aim to compare the two in different aspects of probable improvement in the age old technique of Meshplasty with sutures which is widely used and is known to be commonly associated with post operative chronic pain.     
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