FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/074178 [Registered on: 23/09/2024] Trial Registered Prospectively
Last Modified On: 13/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to assess the feasibility and safety of plastic tube placed in ureter(tube connecting kidney and bladder) with a string attached to conventional plastic tubes with two coils  
Scientific Title of Study   A prospective randomized control study assessing the feasibility and safety of complete intra-ureteric stent on a string following upper tract ureteroscopy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aswath V 
Designation  Senior registrar 
Affiliation  Christian Medical College, Vellore  
Address  Department of Urology Christian Medical college Ranipet Campus Vellore

Vellore
TAMIL NADU
632517
India 
Phone  09739868215  
Fax    
Email  aswathv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajadoss  
Designation  Professor  
Affiliation  Christian Medical College  
Address  Department of Urology Christian Medical College Ranipet Campus Vellore

Vellore
TAMIL NADU
632517
India 
Phone    
Fax    
Email  rajadoss@cmcvellore.ac.in  
 
Details of Contact Person
Public Query  
Name  Aswath V 
Designation  Senior registrar  
Affiliation  Christian Medical College  
Address  Department of Urology CMC Vellore Ranipet Campus Vellore - 632517

Vellore
TAMIL NADU
632517
India 
Phone  9739868215  
Fax    
Email  aswathv@gmail.com  
 
Source of Monetary or Material Support  
Christian Medical College, Ranipet Campus Vellore- 632517 India  
 
Primary Sponsor  
Name  Christian Medical Collge  
Address  Department of Urology Christian Medical College Ranipet Campus Vellore- 632517 India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aswath V  Christian Medical College   Department of Urology Christian Medical college Ranipet Campus , Vellore
Vellore
TAMIL NADU 		 9739868215

aswathv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
OFFICE OF RESEARCH INSTITUTIONAL REVIEW BOARD (IRB) CHRISTIAN MEDICAL COLLEGE, VELLORE, INDIA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  Conventional double J stents   Following upper tract ureteroscopic stone removal; conventional double J stent will be inserted in comparator arm; for a period less than or equal to 1 week  
Intervention  Placement of complete intraureteric stent on string   Following upper tract ureteroscopic stone removal; complete intraureteric stent with string will be inserted; for period less than or equal to 1 week  
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All patients who have a ureteric stent inserted after upper tract ureteroscopic procedures for unilateral stone disease  
 
ExclusionCriteria 
Details  pediatric patients, patients undergoing bilateral procedures, anatomical abnormalities, solitary functioning kidney, incomplete treatment, planned for staged procedures, coexisting non calculous diseases, prior ureteric stenting, impacted vesico-ureteric junction calculus and complicated URSL requiring long term stent placement  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the quality of life , stent related symptoms and complication rates between ureteric stent on strings and conventional ureteric stent using the validated Ureteral Stent Symptom Questionnaire   USSQ score assessed on post op day (POD) 1, POD3, prior to stent removal and 1 day after stent removal  
 
Secondary Outcome  
Outcome  TimePoints 
1. To study the cost effectiveness of complete intra- ureteric stent with attached strings.  From september 2024  
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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/ Phase 3 
Date of First Enrollment (India)   24/09/2024 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aswathv@gmail.com].

  6. For how long will this data be available start date provided 15-09-2024 and end date provided 15-03-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Ureteroscopy (URS) is a common procedure for removing upper urinary tract stones. Ureteric stent placement after URS is a routine practice. Placement of conventional ureteric stents is associated with stent related symptoms due to irritation of the bladder by the intravesical lower coil. Conventional stents are routinely removed using cystoscopy which entail added cost and discomfort which may be circumvented by stent on strings that may be pulled out by the patient/ clinician without the need for cystoscopy. This study aims to assess the safety and feasibility of complete intra- ureteric stent with attached strings following upper tract ureteroscopy 
Close