| CTRI Number |
CTRI/2025/01/079821 [Registered on: 31/01/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of post operative Sterile water irrigation on recurrence of Non Muscle-Invasive Bladder Cancer, a Randomised Control Trial |
|
Scientific Title of Study
|
Outcome and Safety of Sterile Water Irrigation vs Normal Saline Irrigation following TURBT in patients with Non Muscle Invasive Bladder Cancer A Randomized Controlled 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 |
Devesh Dhamor |
| Designation |
Senior Resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Advanced Urology Centre (26) First Floor, Level 2 Nehru Hospital,
Post graduate institute of medical education and research(PGIMER)
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9971760360 |
| Fax |
|
| Email |
deveshdhamor.pgimer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Santosh Kumar |
| Designation |
Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Advanced Urology Centre (26) First Floor, Level 2 Nehru Hospital,
Post graduate institute of medical education and research(PGIMER)
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009321 |
| Fax |
|
| Email |
santoshsp1967jaimatadi@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Santosh Kumar |
| Designation |
Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Advanced Urology Centre (26) First Floor, Level 2 Nehru Hospital,
Post graduate institute of medical education and research(PGIMER)
CHANDIGARH
160012
India |
| Phone |
7087009321 |
| Fax |
|
| Email |
santoshsp1967jaimatadi@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Post graduate institute of medical education and research, Chandigarh, PIN- 160012, India |
|
|
Primary Sponsor
|
| Name |
Post graduate institute of medical education and research Chandigarh |
| Address |
Madhya Marg Nehru Hospital Level II , First Floor Post Graduate
Institute of Medical Education and Research Chandigarh, Sector 12
160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Devesh Dhamor |
Nehru Hospital (Post Graduate Institute of Medical Education and Research) |
Advanced Urology
Centre (26), Urology
Office , LEVEL II, Nehru
Hospital, Post Graduate
Institute of Medical
Education and
Research,Madhya
Marg,
Chandigarh
CHANDIGARH |
9971760360
deveshdhamor.pgimer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, Post Graduate Institute of Medical Education and Research, Chandigarh |
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 |
Group S: Normal saline irrigation |
Post operative irrigation will be given via 0.9% w/v normal saline for a minimum period of 24 hours at a rate enough to obtain a clear output from the per urethral catheter and longer thereafter if hematuria does not settle by that period. The number of bottles of irrigant used will be recorded till the time irrigation was continued in the post operative period. Electrolytes will be monitored every 12 hourly along with periodic vital monitoring |
| Intervention |
Group W: Sterile water irrigation |
Post operative irrigation will be given via sterile water for a minimum period of 24 hours at a rate enough to obtain a clear output from the per urethral catheter and longer thereafter if hematuria does not settle by that period. The number of bottles of irrigant used will be recorded till the time irrigation was continued in the post operative period. Electrolytes will be monitored every 12 hourly along with periodic vital monitoring |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing TURBT for suspected Bladder Cancer;
Giving free and informed consent;
Resection completed within 1 hour;
Complete resection done in a single setting |
|
| ExclusionCriteria |
| Details |
Metastatic, recurrent or muscle invasive disease
Coexistent Upper Tract involvement
High risk of fluid overload or hyponatremia with EF less than 40%, DCMP, eGFR less than 30 ml/min, pre operative hyponatremnia |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the rate of recurrence after TURBT among the two groups |
3,6,9,12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the safety profile of sterile water irrigation after TURBT among the two groups |
0,12,24 hours |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
12/02/2025 |
| 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="0"
Days="5" |
|
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
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [deveshdhamor.pgimer@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomised , parallel group , active control, single-centre trial to study the role of sterile water irrigation fluid in the post operative period in the prevention of recurrence of disease in patients undergoing Trans Urethral Resection of Bladder Tumour (TURBT). The primary outcome measures will be to compare the incidence of recurrence and assess safety (by documenting symptomatic hyponatremia) among the two groups following elective surgery. The patients will be assessed at 3,6,9 and 12 months for recurrence using cystoscopy. The secondary outcome will be to assess the safety profile of sterile water irrigation. Hourly assessment of vital parameters and 12th hourly electrolyte monitoring will be done. |