| CTRI Number |
CTRI/2026/01/100315 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
04/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To study double J stent duration before doing flexible URS for kidney and upper ureter stones. |
|
Scientific Title of Study
|
A Prospective Study Of Short Intermediate And Long Term Pre Operative Double J Ureteral Stent Duration In Flexible URS For Renal And Proximal Ureteric Calculi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prateek Pant |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Hospital KMC Manipal |
| Address |
OPD No.14 OPD Block Kasturba Hospital Manipal Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9458707326 |
| Fax |
|
| Email |
19prateekpant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anupam Choudhary |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Hospital KMC Manipal |
| Address |
OPD No 14 OPD Block Kasturba Hospital Manipal Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9880635885 |
| Fax |
|
| Email |
anupam.choudhary@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Prateek Pant |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Hospital KMC Manipal |
| Address |
OPD No.14 OPD Block Kasturba Hospital Manipal Karnataka 576104
KARNATAKA
576104
India |
| Phone |
9458707326 |
| Fax |
|
| Email |
19prateekpant@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital Manipal |
|
|
Primary Sponsor
|
| Name |
Prateek Pant |
| Address |
OPD No.14 OPD Block Kasturba Hospital Manipal Karnataka 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Prateek Pant |
Kasturba Hospital |
OPD No 14 OPD Block Dept Of Urology and Renal Transplant
Udupi
KARNATAKA |
9458707326
19prateekpant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
Age more than 18 years
Patients undergoing flexible URS for
Renal calculi
Proximal ureteric stones
Stone Size less than 20 mm in size single or multiple
Patients planned for preoperative ureteral stenting
Willingness to participate and provide informed consent
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
Distal ureteric stones
History of ureteral strictures or prior ureteral surgery
Uncorrected anatomical abnormalities eg horseshoe kidney PUJ obstruction
Previous flexible URS on the same side within the past 6 months
Patients with indwelling stents
Difficulty in placing pre operative DJ Stent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Stone Free Rate after 30 days
Ureteral dilatation
Assessment of ureteral injury post procedure
Urinary Stones and Intervention Quality of Life Measure
|
intra op
post op
30 days after procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
02/02/2026 |
| 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="6"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
Flexible Ureteroscopic Surgery has emerged as a widely accepted and minimally invasive procedure for managing renal and proximal ureteric stones. A critical factor influencing the success and safety of flexible URS is the ease of flexible ureteroscopic access, which can be enhanced by preoperative ureteral stenting. There is no clear consensus in current urological guidelines regarding the optimal duration of preoperative stenting. In practice urologists use varying durations ranging from a few days to several weeks—based on clinical judgment rather than strong evidence. Therefore, a prospective study comparing short intermediate and long term preoperative stent durations is necessary to identify the most effective and safe stenting strategy. |