| CTRI Number |
CTRI/2026/02/104440 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Kidney stone patients undergoing endoscopic surgery: comparison of ureteral stent versus medicine before surgery to improve stone clearance and recovery |
|
Scientific Title of Study
|
Comparison of short-term preoperative stenting and preoperative silodosin administration on outcomes of RIRS for renal stones |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IPGME&R/IEC/2026/0022 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KUMAR RAJIV RANJAN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
IPGMER AND SSKM HOSPITAL |
| Address |
DEPARTMENT OF UROLOGY
IPGMER AND SSKM HOSPITAL
244 AJC BOSE ROAD
KOLKATA
Kolkata
WEST BENGAL
700038
India |
| Phone |
9432513295 |
| Fax |
|
| Email |
dr.ranjanrajiv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MRIDUL GERA |
| Designation |
POST DOCTORAL TRAINEE |
| Affiliation |
IPGMER AND SSKM HOSPITAL |
| Address |
DEPARTMENT OF UROLOGY
IPGMER AND SSKM HOSPITAL
244 AJC BOSE ROAD
KOLKATA
Kolkata
WEST BENGAL
700038
India |
| Phone |
9350254136 |
| Fax |
|
| Email |
dcgera180@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MRIDUL GERA |
| Designation |
POST DOCTORAL TRAINEE |
| Affiliation |
IPGMER AND SSKM HOSPITAL |
| Address |
DEPARTMENT OF UROLOGY
IPGMER AND SSKM HOSPITAL
244 AJC BOSE ROAD
KOLKATA
Kolkata
WEST BENGAL
700038
India |
| Phone |
9350254136 |
| Fax |
|
| Email |
dcgera180@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IPGMER AND SSKM HOSPITAL |
| Address |
DEPARTMENT OF UROLOGY
IPGMER AND SSKM HOSPITAL
244 AJC BOSE ROAD
KOLKATA |
| 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 |
| MRIDUL GERA |
IPGMER AND SSKM HOSPITAL |
ROOM NO-1 , 5TH FLOOR
DEPARTMENT OF UROLOGY
IPGMER AND SSKM HOSPITAL
244 AJC BOSE ROAD
Kolkata
WEST BENGAL |
9350254136
dcgera180@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
SILODOSIN |
SILODOSIN 8mg daily for 7 days prior to RIRS without stenting |
| Intervention |
Ureteral stenting |
Preoperative ureteral stenting 14 days prior to RIRS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with renal calculi 5-20mm indicated for RIRS
2. No history of previous ureteral stenting or ureteric surgery |
|
| ExclusionCriteria |
| Details |
1. Patients with ureteral stones
2. Active urinary tract infection
3. Single or multiple renal stones in a single functioning kidney
4. Pregnancy
5. Coagulopathy or on anti-coagulant therapy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stone free rate at 2-4 weeks post operatively |
outcomes will be assessed at baseline, 4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Operative time |
Outcome will be assessed at baseline, 4 weeks & 8 weeks |
| Need for ureteral dilatation |
Outcome will be assessed at baseline, 4 weeks & 8 weeks |
| Intraoperative ureteral injury |
Outcome will be assessed at baseline, 4 weeks & 8 weeks |
| Postoperative complications |
Outcome will be assessed at baseline, 4 weeks & 8 weeks |
| Hospital stay duration |
Outcome will be assessed at baseline, 4 weeks & 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/03/2026 |
| 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="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
|
This prospective randomized controlled trial aims to compare the effectiveness of short term preoperative ureteral stenting with preoperative silodosin administration in improving outcomes of RIRS for renal stones. Sixty adult patients with renal calculi planned for RIRS will be randomized into two groups . Primary outcome include stone- free rate at 2-4 weeks. Secondary outcomes include operative time, need for ureteral dilatation, intraoperative ureteral injury, postoperative complications and hospital stay. The study aims to determine whether pharmacological ureteral relaxation with silodosin can provide outcomes comparable to mechanical dilation achieved by prestenting, thereby potentially reducing the need for invasive preoperative stenting. |