| CTRI Number |
CTRI/2024/12/078061 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative study of early versus late removal of per urethral catheter after urethral stricture surgery. |
|
Scientific Title of Study
|
A Comparative study of early versus late removal of per urethral catheter after anterior anastomotic and buccal mucosal onlay urethroplasty. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sai Bharath Nandula |
| Designation |
Mch Urology Resident |
| Affiliation |
IPGMER and SSKM Hospital, Kolkata |
| Address |
Urology Department, 5 th floor, Urology Nephrology Department, IPGMER and SSKM Hospital, Bhawanipur, 244 AJC Bose Road, Kolkata.
Kolkata
WEST BENGAL
700020
India |
| Phone |
9490336677 |
| Fax |
|
| Email |
saibharathnandula@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soumya Mondal |
| Designation |
Associate Professor |
| Affiliation |
IPGMER and SSKM Hospital, Kolkata |
| Address |
Urology Department, 5 th floor, Urology and Nephrology building, IPGMER and SSKM Hospital, Bhawanipur, 244 AJC Bose road, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433119700 |
| Fax |
|
| Email |
dr.soumya.mondal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sai Bharath Nandula |
| Designation |
Mch Urology Resident |
| Affiliation |
IPGMER and SSKM Hospital, Kolkata |
| Address |
Urology Department, 5 th floor, Urology Nephrology Department, IPGMER and SSKM Hospital, Bhawanipur, 244 AJC Bose Road, Kolkata.
Kolkata
WEST BENGAL
700020
India |
| Phone |
9490336677 |
| Fax |
|
| Email |
saibharathnandula@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGMER and SSKM Hospital, Bhawanipur, 244 AJC Bose Road, Kolkata,West Bengal, India.Pin Code - 700020 |
|
|
Primary Sponsor
|
| Name |
Sai Bharath Nandula |
| Address |
Urology Department, 5 th floor, Urology and Nephrology Building,IPGMER and SSKM Hospital, Bhawanipur, 244 AJC Bose Road, Kolkata,West Bengal, India.Pin Code - 700020 |
| 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 Sai Bharath Nandula |
IPGMER and SSKM Hospital, Kolkata |
Department of Urology, 5 th floor, Urology and Nephrology building, IPGMER and SSKM Hospital, 244 AJC Bose Road, Bhawanipur, Kolkata.Pin Code - 700020
Kolkata
WEST BENGAL |
9490336677
saibharathnandula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER Research Oversight Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N359||Urethral stricture, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Early removal |
Early removal of per urethral catheter after anastomotic and buccal mucosal onlay urethroplasty surgery which is done on 7 th and 14 th day after surgery respectively. |
| Comparator Agent |
Late removal |
Late removal of per urethral catheter after anastomotic and buccal mucosal onlay urethroplasty surgery which is done on 14th and 21st day after surgery respectively. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
Patients diagnosed with urethral stricture disease and who underwent anastomotic and buccal mucosal onlay urethroplasty. |
|
| ExclusionCriteria |
| Details |
Patients with history of previous repair, chronic kidney disease, uncontrolled diabetes mellitus and who received radiotherapy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Extravasation rates, duration of catheterization. |
Extravasation rates on 7th, 14th for anastomotic urethroplasty and 14th and 21st day for buccal mucosal onlay urethroplasty. Duration of catheterization measured on 21st day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recurrence of stricture rates. |
Recurrence rates studied at 3 & 6 months after surgery. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/12/2024 |
| Date of Study Completion (India) |
21/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 is a parallel arm, randomized controlled study in which after urethroplasty surgery patients are followed up. Early removal of catheter has advantages of reduced urinary tract infection rates, better comfort to the patient and reduced recurrence rate of stricture, In the intervention group, per urethral urethrogram is done 7 days early than comparator group which is within the optimum range of duration of catheterization. The extravasation rates are measured and catheter is removed when there is no extravasation. The extravasation rates, duration of catheterization and recurrence rates of both groups are compared and the feasibility of early removal is to be determined. |