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CTRI Number  CTRI/2022/04/042048 [Registered on: 21/04/2022] Trial Registered Prospectively
Last Modified On: 13/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Different methods of mesh fixation in hernia surgery: a comparision of post operative outcomes 
Scientific Title of Study   Comparison between Sutures, N-butyl-2cyanoacrylate and Self- gripping mesh in Lichtenstein Hernia repair- A multi arm randomized control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sagar P 
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  7676746974  
Fax    
Email  sagar0496@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vijayakumar c 
Designation  Assistant professor 
Affiliation  JIPMER 
Address  Jipmer Campus Rd, Gorimedu, Priyadarshini Nagar, Puducherry, 605006. room 86, second floor, OPD block.
Jipmer Campus Rd, Gorimedu, Priyadarshini Nagar, Puducherry, 605006. IPD block, second floor, ward-34
Pondicherry
PONDICHERRY
605006
India 
Phone  7676746974  
Fax    
Email  vijaymmc01@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sagar P 
Designation  Junior resident 
Affiliation  JIPMER 
Address  Jipmer Campus Rd, Gorimedu, Priyadarshini Nagar, Puducherry, 605006. OPD block,second floor, room 86
Jipmer Campus Rd, Gorimedu, Priyadarshini Nagar, Puducherry, 605006. IPD block, second floor, ward 31.
Pondicherry
PONDICHERRY
605006
India 
Phone  7676746974  
Fax    
Email  sagar0496@gmail.com  
 
Source of Monetary or Material Support  
JIPMER Jipmer Campus Rd, Gorimedu, Priyadarshini Nagar, Puducherry, 605006. 
 
Primary Sponsor  
Name  JIPMER 
Address  JIPMER, Puducherry 
Type of Sponsor  Research institution and hospital 
 
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 Sagar P  JIPMER  Jipmer Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006 ROOM NUMBER 86, SECOND FLOOR OLD BUIDLING, OPD BLOCK, DEPARTMENT OF SURGERY.
Pondicherry
PONDICHERRY 		 7676746974

sagar0496@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-IEC-JIPMER   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  n-butyl-2cyanoacrylate gel  mesh fixation will be done with n-butyl-2cyanoacrylate gel in this arm  
Comparator Agent  self gripping mesh  self gripping mesh will be used for fixation of mesh. 
Intervention  Sutures for mesh fixation  here sutures will be used to fix the mesh in hernia repair. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All consenting patients with primary elective uni- lateral uncomplicated inguinal hernia planned for open mesh repair. 
 
ExclusionCriteria 
Details  1. Recurrent or giant inguinal hernia with loss of do- main.
2. Hernia patients with disorders of hemostasis and coagulation
3. Chronic pain due to previously operated opposite side or due to any other medical problems
4. Patients 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 and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of sutures vs N-butyl-2-cy- anoacrylate vs self-gripping mesh for mesh 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 numbness and hematoma, seroma, rate of SSI, urinary retention, length of operation, intraoperative time for mesh fixation, Length of hospital stay and time to re- turn to work) between the three groups

2. To compare the long-term outcomes (Chronic pain, recurrence and cost benefit analysis), between the three groups.
3. To analyse cost effectiveness between the three groups
 		 day 0,1,2,7,30 and after 6 months of surgery 
 
Target Sample Size   Total Sample Size="93"
Sample Size from India="93" 
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)   01/05/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil yet 
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?

  2. What additional supporting information will be shared?

  3. Who will be able to view these files?

  4. For what types of analyses will this data be available?

  5. By what mechanism will data be made available?

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - 
Brief Summary   This study is going to be a three arm RCT comparing three efficient methods of mesh fixation in elective hernia repair to compare the outcomes of surgery post operatively. Using sutures, N-butyl-2cyanoacrylate and self gripping mesh we aim to compare the three 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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