| CTRI Number |
CTRI/2024/11/076552 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomized controlled trial comparing recurrence at three months between non irrigation and irrigation after cystoscopic removal of bladder cancer less than or equal to three centimeters in size and less than or equal to three in number A study at a single hospital. |
|
Scientific Title of Study
|
A randomized controlled trial comparing post transurethral resection of bladder tumor recurrence at three months non continuous bladder irrigation vs continuous bladder irrigation for bladder tumors less than or equal to three centimeters in size and less than or equal to three in number A single center 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 |
Vineet Kala |
| Designation |
Senior registrar |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Urology,
Christian Medical College and Hospital Vellore, Ranipet Campus, Ranipet
Vellore
TAMIL NADU
632517
India |
| Phone |
7231048110 |
| Fax |
|
| Email |
kalaguddu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nirmal T J |
| Designation |
Professor and head of urology unit 3 |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Urology,
Christian Medical College and Hospital Vellore, Ranipet Campus, Ranipet
Vellore
TAMIL NADU
632517
India |
| Phone |
9894449526 |
| Fax |
|
| Email |
nirmaltj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vineet Kala |
| Designation |
Senior Registrar |
| Affiliation |
Christian Medical College |
| Address |
Department of Urology,
Christian Medical College and Hospital Vellore, Ranipet Campus, Ranipet
Vellore
TAMIL NADU
632517
India |
| Phone |
7231048110 |
| Fax |
|
| Email |
kalaguddu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian Medical College, Vellore, Tamil Nadu, India,
632517 |
|
|
Primary Sponsor
|
| Name |
Christian Medical College |
| Address |
Christian Medical College and Hospital Vellore, Ranipet Campus Ranipet |
| Type of Sponsor |
Private 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 |
| Vineet kala |
Christian Medical College |
Department of Urology,
Christian Medical College and Hospital Vellore, Ranipet Campus, Ranipet
Vellore
TAMIL NADU |
7231048110
kalaguddu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board (Silver Ethics and Research Committee) of the Christian Medical College Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C679||Malignant neoplasm of bladder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Continous bladder irrigation arm |
Proceed with transurethral resection of bladder tumour,
22 Fr 3-way Foley’s catheter will be inserted.
The patient will be given intra-vesical Mitomycin.
Continuous bladder irrigation will be started at 2,000 mL/h for the first hour, followed by 1,000 mL/h for the next two hours, and 500 mL/h until 6 AM the next day or stop early as per the surgeons preference. |
| Intervention |
Non continuous bladder irrigation arm |
Proceed with transurethral resection of bladder tumor,
22 Fr 3-way Foley’s catheter will be inserted.
The patient will be given intra-vesical Mitomycin.
No continuous bladder irrigation will be started following one hour of Mitomycin instillation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Bladder tumours (≤ 3 cm and ≤ 3 in numbers) |
|
| ExclusionCriteria |
| Details |
1) Refused consent largest tumor more than 3 cm or more than 3 tumors on imaging and cystoscopy on anti-coagulation on antiplatelets (Dual or more than 75 mg ecospirin bleeding diathesis) presenting with a bladder clot or active hemorrhage diverticular tumors not fit for anesthesia diagnosed as more than equal to T2 in HPE |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bladder tumour recurrence at 3 months |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hematuria requiring cystoscopic bladder wash and coagulation |
Upto 7 days |
| Need of continuous bladder irrigation into ward ( For non CBI Arm) |
Upto 7 days |
| Pharmacy cost or hospital stay cost |
Upto 7 days |
| Time to catheter removal |
Upto 7 days |
|
|
Target Sample Size
|
Total Sample Size="190"
Sample Size from India="190"
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 3 |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
Continuous bladder irrigation (CBI) is commonly used after
transurethral resection of bladder tumours. CBI involves a continuous flow of saline
into the bladder through a catheter to prevent blood clots from forming and
obstructing the urinary tract. It also prevents re-implantation and reduces
recurrence post transurethral resection of bladder tumours (TURBT). Continuous bladder irrigation has been proposed
as a potential intervention to reduce the risk of recurrence, although existing
evidence is inconclusive and based on non randomized retrospective studies. Our
aim is to scrutinize the efficacy of omitting continuous bladder irrigation in
relation to the risk of recurrence at 3 months in <3 cm in size, ≤3 in
number tumors. Additionally, we will assess postoperative increases in adverse
events and conduct a cost analysis. |