| CTRI Number |
CTRI/2024/04/065584 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Evaluate if intravesical epinephrine irrigation improves the postoperative outcomes in patients undergoing resection of Bladder Tumor as compared to normal saline irrigation |
|
Scientific Title of Study
|
A Randomized Controlled Trial on Evaluating the safety and efficacy of intravesical epinephrine irrigation on postoperative outcomes in patients undergoing Transurethral resection of Bladder Tumor. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saharsh Ambade |
| Designation |
senior resident |
| Affiliation |
All India Institute Of Medical Science, Bhubaneswar |
| Address |
Department of Urology, 2nd Floor. AIIMS Bhubaneswar
Kendrapara
ORISSA
751019
India |
| Phone |
8586097324 |
| Fax |
|
| Email |
ambade3582@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swarnendu Mandal |
| Designation |
senior resident |
| Affiliation |
All India Institute Of Medical Science, Bhubaneswar |
| Address |
Dept of Urology , 2nd Floor , AIIMS Bhubaneswar
Kendrapara
ORISSA
751019
India |
| Phone |
8447562972 |
| Fax |
|
| Email |
urol_swarnendu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saharsh Ambade |
| Designation |
senior resident |
| Affiliation |
All India Institute Of Medical Science, Bhubaneswar |
| Address |
Department of Urology , 2nd Floor , AIIMS Bhubaneswar
Kendrapara
ORISSA
751019
India |
| Phone |
8586097324 |
| Fax |
|
| Email |
ambade3582@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Urology, AIIMS, Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
Department of Urology |
| Address |
Department of Urology, AIIMS , Bhubaneswar |
| 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 Saharsh Ambade |
All India Institute Of Medical Sciences , Bhubaneswar |
Department of urology, 2nd floor , AIIMS, Bhubaneswar , Patrapada , Odisha
Kendrapara
ORISSA |
8586097324
ambade3582@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N328||Other specified disorders of bladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravesical epinephrine |
In the post operative period, the test group will receive continuous intravesical bladder irrigation
with 1:100,000 diluted epinephrine (10 ml 1:1000 epinephrine further diluted with 990 mL of
normal saline) will be maintained at 100-150 mL/hr for 12 under cardiovascular monitoring |
| Comparator Agent |
Intravesical Saline irrigation |
The patients in the control
group will receive the intravesical normal saline irrigation in the intra-operative and post operative period
till POD1 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with bladder tumor undergoing TURBT
Patients undergoing en-bloc resection of bladder tumour
Patients undergoing en-bloc resection of bladder tumour using laser (HOLERBT) |
|
| ExclusionCriteria |
| Details |
ASA Grade 3 or more.
Patients with incomplete tumour clearance
Patients undergoing TUR biopsy for large bladder mass
Patients undergoing restaging TURBT
Patients with intraoperative deep bladder resection that requires prolonged
catheterization
Patients with congenital or acquired Hyper/ hypocoagulation disorders.
Patients with hematological malignancies.
Patients with decompensated chronic liver disease or renal impairment or other
bleeding diathesis.
Patients with a history of thromboembolic disease.
Patients with history of arrhythmias
Patients with uncontrolled hypertension
ï‚· Patients with a history of acute coronary syndrome within the past 12 months |
|
|
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 |
To compare the mean indwelling catheter time in patients undergoing TURBT in those
receiving intravesical normal saline vs continuous epinephrine solution irrigation |
at discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the postoperative hematuria in patients undergoing TURBT in those
receiving intravesical normal saline vs continuous epinephrine solution irrigation
2. To compare the length of hospitalization in patients undergoing TURBT in those
receiving intravesical normal saline vs continuous epinephrine solution irrigation
3. To compare the secondary hematuria in patients undergoing TURBT in those
receiving intravesical normal saline vs continuous epinephrine solution irrigation |
6 hrs , 12 hrs , 1 month |
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
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)
|
24/04/2024 |
| 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="6"
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
|
Patient undergoing TURBT for bladder tumor had risk of bleeding from bladder in post operative period, So patient are kept in foley catheter for 2-3 days with continous intravesical saline irrigaaion to prevent clot formation. The purpose of this trial is to evaluate the efficacy of intravesical epinephrine infused saline irrigation as compared to normal saline irrigation on peri-operative outcomes including mean indwelling catheter time, postoperative hematuria, length of hospitalization and secondary hematuria and to decrease the cathetor indwelling time and post op bleeding |