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CTRI Number  CTRI/2023/12/060672 [Registered on: 22/12/2023] Trial Registered Prospectively
Last Modified On: 05/10/2024
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   Stent removal after one week compared with conventional stent removal after six weeks following a laparoscopic operation for obstruction in the urinary passage in children: A randomised control trial. 
Scientific Title of Study   DJ stent removal after one-week versus six-weeks in paediatric laparoscopic pyeloplasty: A prospective randomised controlled trial.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Badhrinath J  
Designation  Senior Resident 
Affiliation  Christian Medical College Vellore 
Address  Department of Urology, Christian Medical College Vellore, Ranipet campus Kilminnal – 632517 04172224647

Vellore
TAMIL NADU
632517
India 
Phone  9944187879  
Fax    
Email  badhrinj@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chandrasingh J 
Designation  Head of the Department  
Affiliation  Christian Medical College Vellore 
Address  Department of Urology, Christian Medical College Vellore, Ranipet campus Kilminnal – 632517 04172224647
Department of Urology, Christian Medical College Vellore, Ranipet campus Kilminnal – 632517 04172224647
Vellore
TAMIL NADU
632517
India 
Phone  9442609368  
Fax    
Email  chandrasingh@cmcvellore.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Badhrinath J  
Designation  Senior Resident 
Affiliation  Christian Medical College Vellore 
Address  Department of Urology, Christian Medical College Vellore, Ranipet campus Kilminnal – 632517 04172224647


TAMIL NADU
632517
India 
Phone  9944187879  
Fax    
Email  badhrinj@gmail.com  
 
Source of Monetary or Material Support  
CHRISTIAN MEDICAL COLLEGE FLUID GRANT Department of Urology, Christian Medical College Vellore, Ranipet campus Kilminnal – 632517 
 
Primary Sponsor  
Name  Christian Medical College Vellore 
Address  Department of Urology, Christian Medical College Vellore, Ranipet campus Kilminnal – 632517 04172224647 
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 Badhrinath J  Christian Medical College, Vellore  Department of Urology, Christian Medical College Vellore, Ranipet campus Kilminnal – 632517
Vellore
TAMIL NADU 		 9944187879

badhrinj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of research, Institutional Review Board, 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: N00-N99||Diseases of the genitourinary system, (2) ICD-10 Condition: N130||Hydronephrosis with ureteropelvicjunction obstruction, (3) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DJ stent removal at one week.   Removal of DJ stent after one week of surgery in children undergoing Paediatric Laparoscopic pyeloplasty. 
Comparator Agent  DJ stent removal at six weeks.   Removal of DJ stent after six weeks of surgery in patients undergoing Paediatric Laparoscopic pyeloplasty. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Children between one year and 16 years of age
undergoing Laparoscopic pyeloplasty for Pelvi-ureteric junction. 
 
ExclusionCriteria 
Details  Open pyeloplasty, Age> 16 years, recurrent PUJO, those unwilling to participate, any patient with intra-op decision for longer duration of stenting, lost to follow-up in less than six months.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Stent related discomfort such as Flank pain/ supra-pubic pain on Visual analog score, frequency of urination, urgency, need for medications - anticholinergics. The outcomes are assessed prior to stent removal in both the groups.   One week for treatment group and six weeks in the control group.  
 
Secondary Outcome  
Outcome  TimePoints 
Rates of infection, obstruction, need for
repeat stenting/ pyeloplasty, change in relative function and drainage of the affected kidney, length of hospital stay and cost.
 		 One week, six weeks & six months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/01/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [BADHRINJ@GMAIL.COM].

  6. For how long will this data be available start date provided 15-01-2026 and end date provided 15-11-2036?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This study is a randomised, parallel group, active controlle single centre study comparing the outcomes of DJ stent removal in children undergoing laparoscopic pyeloplasty for pelvi-ureteric junction obstruction at one week versus six weeks. The primary outcome will be stent related discomfort at one week and six weeks. The secondary outcomes will be rates of infection, obstruction, need for repeat stenting/ pyeloplasty, change in relative function and drainage of the affected kidney, length of hospital stay and cost at one week, six weeks & six months.

 
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