| CTRI Number |
CTRI/2024/06/068250 [Registered on: 03/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| 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
|
Comparison of fixation and non fixation of mesh in Day care laparoscopic totally extraperitoneal repair of inguinal hernia |
|
Scientific Title of Study
|
Comparison of fixation and non-fixation of mesh in daycare laparoscopic totally extra-peritoneal repair of indirect inguinal hernia: a randomised controlled study |
| 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 Anubhav Vindal |
| Designation |
Professor |
| Affiliation |
Maulana azad medical college |
| Address |
Room no 215, 3rd floor, Dept of General surgery, BL Taneja block, Maulana Azad Medical college,Bahadur Shah zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9968604403 |
| Fax |
|
| Email |
anubhav.vindal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anubhav Vindal |
| Designation |
Professor |
| Affiliation |
Maulana azad medical college |
| Address |
Room no 215, 3rd floor, Dept of General surgery, BL Taneja block, Maulana Azad Medical college,Bahadur Shah zafar Marg, New Delhi
DELHI
110002
India |
| Phone |
9968604403 |
| Fax |
|
| Email |
anubhav.vindal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lalropuia |
| Designation |
Postgraduate student |
| Affiliation |
Maulana azad medical college |
| Address |
Room no 215, 3rd floor, Dept of General surgery, BL Taneja block, Maulana Azad Medical college,Bahadur Shah zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
8118982148 |
| Fax |
|
| Email |
lalropuiajongte@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana azad medical college, Bahadur Shah Zafar Marg, New Delhi, India. 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana azad medical college |
| Address |
Bahadur Shah Zafar Marg, New Delhi, India. 110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anubhav Vindal |
Maulana azad medical college |
Room no 215, Dept of of General surgery, BL Taneja block, Maulana azad medical college, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI |
9968604403
anubhav.vindal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Maulana azad medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Day care laparoscopic totally extraperitoneal repair of inguinal hernia |
Recurrence of inguinal hernia at 3 months in a daycare laparoscopic totally extraperitoneal repair of inguinal hernia- in fixation of mesh group |
| Intervention |
Day care laparoscopic totally extraperitoneal repair of inguinal hernia |
Recurrence of inguinal hernia at 3 months in a daycare laparoscopic totally extraperitoneal repair of inguinal hernia- non fixation of mesh group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1.All the patient undergoing day care laparoscopic totally extraperitoneal repair of indirect inguinal hernia
2. More than 18 years of age |
|
| ExclusionCriteria |
| Details |
1. RECURRENT INGUINAL HERNIA
2. DIRECT INGUINAL HERNIA |
|
|
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 |
| Recurrence of inguinal hernia |
At 3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative pain |
After 24 hours,1 week, 1 months, 3 months |
| Patient satisfaction |
After 24 hours,1 week, 1 month, 3 month |
| Any other complications |
After 24 hours, 1 week, 1 month, 3 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
|
N/A |
|
Date of First Enrollment (India)
|
11/06/2024 |
| 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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [lalropuiajongte@gmail.com].
- For how long will this data be available start date provided 06-05-2024 and end date provided 30-11-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Patient of indirect inguinal hernia undergoing TEP between the age of >18 years will be included in the study. A total of 20 patients, 10 in each group will be included in the study. The patient will be blinded towards the group allocation to avoid bias toward reporting of outcomes, and independent observer(medical student/intern) will be asked to collect data from the patient in order to ensure observer blinding. The collected data will be analysed only at the end once the accrual of all the patient has been completed. |