| CTRI Number |
CTRI/2024/10/075428 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating how patients feel after having their double J stent removed, comparing experiences right after the procedure to those later on. |
|
Scientific Title of Study
|
ASSESSMENT OF PATIENT REPORTED OUTCOME MEASURES IN EARLY VERSUS LATE DOUBLE J STENT REMOVAL POST-URETEROSCOPIC LITHOTRIPSY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sambit Kar |
| Designation |
Senior resident, Urology |
| Affiliation |
Vardhaman mahaveer medical college |
| Address |
Room no 438, Department of urology, ward-31, Safdarjung hospital, Ansari nagar, Delhi
New Delhi
DELHI
110060
India |
| Phone |
7767953562 |
| Fax |
|
| Email |
ksambit6742@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Mittal |
| Designation |
Associate professor, Urology |
| Affiliation |
Vardhaman mahaveer medical college |
| Address |
Room no 400, Department of urology, 4th floor, SSB, Safderjung hospital, Ansari nagar, New Delhi
New Delhi
DELHI
110060
India |
| Phone |
9571558446 |
| Fax |
|
| Email |
drruchimittalms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sambit Kar |
| Designation |
Senior resident, Urology |
| Affiliation |
VMMC, SJH, NEW DELHI |
| Address |
Room no 438, Department of urology, ward-31, Safdarjung hospital, Ansari nagar, Delhi
New Delhi
DELHI
110060
India |
| Phone |
7767953562 |
| Fax |
|
| Email |
ksambit6742@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of urology, Vardhaman medical college, Safdarjung hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahaveer MedicalCollege Safdarjung hospital Department of urology |
| Address |
4th floor, SSB, Department of urology, Vardhaman Mahaveer Medical College, Safdarjung Hospital |
| 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 |
| SAMBIT KAR |
Vardhaman Mahaveer Medical College, Safdarjung hospital |
Room no 438, 4th floor, SSB, VMMC, Ansari Nagar East, Near to AIIMS Metro Station-110029
South
DELHI |
7767953562
ksambit6742@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vardhaman mahaveer medical college |
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 |
DJ Stent removal at 3rd week |
DJ stent will be removed at third week after the procedure. |
| Intervention |
DJ Stent removal at first week |
DJ Stent will be removed at first week after the procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 years or older undergoing URSL with DJ stent placement who provide informed consent for participation. |
|
| ExclusionCriteria |
| Details |
1. Pregnant women.
2. Non-functional kidneys.
3. Known allergic reactions to materials used in stents.
4. Unable to complete the USSQ due to cognitive impairments.
5. Positive urine culture report.
6. Iatrogenic injury
7. Incomplete stone clearance
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
USSQ score
UTI |
1, 2, 3, 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the incidence of urinary tract infections and stent-related complications in relation to the timing of stent removal. |
1, 2, 3, 4 week |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
29/10/2024 |
| 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
|
Purpose of this study is recruit post URSL patients in two groups as per their DJ stent removal status in early (1 week) or late (3 week) phase and then assess their patient related outcomes. |