| CTRI Number |
CTRI/2025/03/082478 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Role of urinary catheterisation in minimally invasive hernia repairs |
|
Scientific Title of Study
|
Intraoperative urinary catheterization in patients undergoing minimally invasive hernia repair: Trends and outcomes in a tertiary care hospital |
| 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 Ashmita Jain |
| Designation |
Junior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Surgery Block
AIIMS, New Delhi
Ansari Nagar
New Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
8108574526 |
| Fax |
|
| Email |
ashmitajain2019@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr V.K. Bansal |
| Designation |
Professor & Unit Head |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Surgery Block
AIIMS, New Delhi
Ansari Nagar
New Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
9810348479 |
| Fax |
|
| Email |
drvkbansal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Hemanga Bhattacharjee |
| Designation |
Professor & Unit Head |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Surgery Block
AIIMS, New Delhi
Ansari Nagar
New Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
7838621462 |
| Fax |
|
| Email |
dr_hkb75@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Surgery Block
AIIMS, New Delhi
Ansari Nagar
New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Surgery Block
AIIMS, New Delhi
Ansari Nagar
New Delhi - 110029 |
| 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 Ashmita Jain |
AIIMS New Delhi |
Surgery Block
AIIMS, New Delhi
Ansari Nagar
New Delhi - 110029
New Delhi
DELHI |
8108574526
ashmitajain2019@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for POstgraduate Research |
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 |
| Intervention |
Patients undergoing inguinal hernia repair with catheterization intraoperatively |
Patients with inguinal hernia who are understanding minimally invasive hernia repair surgery with intraoperative catheterization will be followed for post operative urinary complications |
| Comparator Agent |
Patients with inguinal hernia undergoing hernia repair without intraoperative catheterization |
Patients undergoing minimally invasive inguinal hernia repair without intraoperative catheterization will be followed post operatively for urinary complications |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 - 80 years
2. patients undergoing elective laparoendoscopic or robot assisted inguinal hernia repair |
|
| ExclusionCriteria |
| Details |
1. Patients with neurogenic bladder or on clean intermittent catheterisation
2. Patients with pre-existing indwelling catheter
3. History of urethral stricture
4. History of suprapubic surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post operative urinary retentio, defined as post operative failure to void requiring straight catheterisation, placement of an indwelling catheter or return to the emergency department due to failure to void after discharge from the hospital.
The incidence of catheterization in previously non-catheterised patients and the incidence of re-catherisation in previously catheterised patients will be recorded |
Day of surgery, Day of discharge, One week from the day of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Duration of urinary catheterization measured in hours from the time of intraoperative insertion of urinary catheter till its removal. (denoted as t1)
2. Duration of catheterization in patients who have had postoperative urinary retention (denoted as t2)
3. Length of postoperative hospital stay in hours between the two groups, defined as time from completion of surgery to time of discharge. Duration of stay in case of readmission will not be taken into account.
4. Rate of readmission due to urinary retention between the two groups
5. Post operative pain will be measured with a numerical pain rating scale (NPRS) of 0 to 10, where 0 is no pain & 10 is maximum possible pain
|
Day of surgery, Day of discharge, One week from the day of surgery |
|
|
Target Sample Size
|
Total Sample Size="350"
Sample Size from India="350"
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)
|
22/03/2025 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims at comparing the incidence of urinary complications in patients undergoing inguinal hernia repair with catheterization with those who are not catheterised. |