| CTRI Number |
CTRI/2025/06/088688 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ureteric calculus patients undergoing Ureteroscopic Lithrotripsy procedure |
|
Scientific Title of Study
|
Comparitive study of Double J stent versus externalized ureteral catheter placement in URSL ( ureteroscopic lithotripsy ) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SANDEEP MAHADEV DESAI |
| Designation |
SENIOR RESIDENT ACADEMIC UROLOGY |
| Affiliation |
AIIMS RAIPUR |
| Address |
FLAT NO 6 , RAM KUTI , FIRST FLOOR , FORTUNE RESIDENCY , TATIBANDH
DEPARTMENT OF UROLOGY , C BLOCK GROUND FLOOR , AIIMS RAIPUR , TATIBANDH , RAIPUR
Raipur
CHHATTISGARH
492099
India |
| Phone |
9867602836 |
| Fax |
|
| Email |
sandeepdesai.urology@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amit Sharma |
| Designation |
Head of Department , Additional Professor |
| Affiliation |
AIIMS Raipur |
| Address |
Department of Urology , Ground floor , C block , AIIMS Raipur , Tatibandh
Raipur
CHHATTISGARH
492099
India |
| Phone |
9867602836 |
| Fax |
|
| Email |
dramitsharma@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
SANDEEP MAHADEV DESAI |
| Designation |
SENIOR RESIDENT ACADEMIC UROLOGY |
| Affiliation |
AIIMS RAIPUR |
| Address |
FLAT NO 6 , RAM KUTI , FIRST FLOOR , FORTUNE RESIDENCY , TATIBANDH
DEPARTMENT OF UROLOGY , C BLOCK GROUND FLOOR , AIIMS RAIPUR , TATIBANDH , RAIPUR
CHHATTISGARH
492099
India |
| Phone |
9867602836 |
| Fax |
|
| Email |
sandeepdesai.urology@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Urology |
| Address |
AIIMS Raipur |
| 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 SANDEEP DESAI |
AIIMS RAIPUR |
DEPARTMENT OF UROLOGY AND RENAL TRANSPLANT , AIIMS RAIPUR , TATIBANDH , RAIPUR
Raipur
CHHATTISGARH |
9867602836
sandeepdesai.urology@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE AIIMS RAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N201||Calculus of ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
URETEROSCOPIC LITHOTRIPSY(URSL) |
DJ STENT PLACEMENT IN OTHER GROUP AFTER URSL SURGERY |
| Intervention |
URETEROSCOPIC LITHOTRIPSY(URSL) |
EXTERNAL URETERAL CATHETER PLACEMENT IN ONE GROUP AFTER URSL SURGERY |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing URSL greater than 18 years of age.
2. Patients with normal anatomy of Upper Urinary Tract.
3. Patients with ureteric stones less than 2 cm |
|
| ExclusionCriteria |
| Details |
1. Patients with Duplication anomalies of the Upper Urinary Tract.
2. Patients with UTI/ Urosepsis.
3. Patients with impacted stones in upper ureter.
4. Patients with LUTS.
5. Patients with intra-operative injuries such as mucosal flap, ureteral perforation and
ureteric orifice dilatation. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain assessment using VAS after EUC placement and DJ stent placement.
|
1 MONTH
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. QOL assessment using USSQ for evaluating stent related symptoms that affect QOL.
2. To compare the complication rates in EUC placement v/s DJ stent placement after URSL surgery.
|
1 MONTH |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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 2 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="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
|
AIM : TO INVESTIGATE THE OUTCOMES OF SHORT TERM PLACEMENT OF A EUC IN COMPARISION TO ROUTINE PLACEMENT OF A DJ STENT AFTER URSL SURGERY.
RESEACH QUESTION : CAN USE OF EXTERNAL URETERAL CATHETER ( EUC ) DECREASE STENT RRLATED SYMPTOMS CAUSED AFTER PLACEMENT OF A DJ STENT ?
HYPOTHESIS : USE OF EXTERNAL URETERAL CATHETER ( EUC ) GIVES LESS STENT RELATED SYMPTOMS AS COMPARED TO DJ STENT PLACEMENT AND ALSO HAS LESS PAIN IN PATIENTS UNDERGOING URSL.
PRIMARY OBJECTIVE : PAIN ASSESSMENT USING VAS AFTER EUC PLACEMENT AND DJ STENT PLACEMENT
SECONDARY OBJECTIVE : QOL ASSESSMENT USING USSQ FOR EVALUATING STENT RELATED SYMPTOMS THAT AFFECT QOL. TO COMPARE COMPLICATION RATES IN EUC PLACEMENT VS DJ STENT PLACEMENT AFTER URSL SURGERY. |