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CTRI Number  CTRI/2024/08/072761 [Registered on: 20/08/2024] Trial Registered Prospectively
Last Modified On: 19/08/2024
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   Comparison between cutting of hernial sac and dissection of hernial sac in Laparoscopic hernia surgery 
Scientific Title of Study   Comparison of Short-Term Outcomes Between Dissection Vs Transection of Hernial Sac in Laparoscopic Extended Totally Extraperitoneal Inguinal Hernia Repair A Double Blinded Randomized Control 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  Sushil Nepali 
Designation  Junior Resident 
Affiliation  JIPMER 
Address  Jipmer Jipmer Campus ROOM 312, JIPMER
Jipmer Jipmer Campus
Pondicherry
PONDICHERRY
605006
India 
Phone  9884303283  
Fax    
Email  joseph.sushil2012@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Uday Shamrao Kumbhar 
Designation  PROFESSOR 
Affiliation  JIPMER 
Address  Department of General Surgery JIPMER Puducherry
Jipmer Campus
Pondicherry
PONDICHERRY
605006
India 
Phone  9940306513  
Fax    
Email  k26uday74@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Sushil Nepali 
Designation  Junior Resident 
Affiliation  JIPMER 
Address  Department of General Surgery JIPMER
Department of General Surgery JIPMER
Pondicherry
PONDICHERRY
605006
India 
Phone  9884303283  
Fax    
Email  joseph.sushil2012@gmail.com  
 
Source of Monetary or Material Support  
JIPMER,PUDUCHERRY, INDIA, 605006 
 
Primary Sponsor  
Name  SUSHIL NEPALI 
Address  JIPMER, PUDUCHERRY, INDIA, 605006 
Type of Sponsor  Other [Self] 
 
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 ABHINAYA REDDY  JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH  DEPARTMENT OF GENERAL SURGERY JIPMER ROOM 7
Pondicherry
PONDICHERRY 		 8195014433

joseph.sushil2012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES, JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R398||Other symptoms and signs involvingthe genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dissection of hernial sac  Dissection of hernial sac in laparoscopic extended totally extraperitoneal inguinal hernia repair Duration- 35mins 
Intervention  Transection of hernial sac  Transection of hernial sac in laparoscopic extended totally extraperitoneal inguinal hernia repair Duration - 25mins 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All consenting patients above 18 years age with primary
unilateral uncomplicated indirect inguinal hernia planned
for elective Laparoscopic eTEP inguinal hernia repair. 
 
ExclusionCriteria 
Details  1 Patients with bubonocele.
2.Pantaloon hernia.
3.Hernia patients with disorder of hemostasis and
coagulation.
4.Previously operated opposite side.
5.Patients undergoing laparoscopic eTEP inguinal hernia
repair with concomitant surgeries.
6.Previous lower abdominal surgeries.
7.Obese patients (BMI>35). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine and compare the sac dissection time, operating
time, and seroma formation rate between transection and
dissection of hernial sac in Laparoscopic eTEP Inguinal Hernia
Repair. 		 8days, 30days and 90 days 
 
Secondary Outcome  
Outcome  TimePoints 
To determine & compare the short-term (3 months) post
operative outcomes between transection & dissection of hernial
sac in Laparoscopic eTEP Inguinal Hernia Repair. 		 8days,30days & 90 days 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   31/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  31/08/2024 
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)   Closed to Recruitment of Participants 
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-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  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 [joseph.sushil2012@gmail.com].

  6. For how long will this data be available start date provided 06-08-2024 and end date provided 07-08-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Comparison Of Short-Term Outcomes Between Dissection Vs
Transection of Hernial Sac in Laparoscopic Extended Totally
Extraperitoneal Inguinal Hernia Repair- A Double Blinded
Randomized Control Trial.
 
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