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CTRI Number  CTRI/2025/11/096913 [Registered on: 04/11/2025] Trial Registered Prospectively
Last Modified On: 14/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   is placing a DJ stent( a hollow tube to keep ureter patent), after routine stone clearing surgery from the tubes draining urine from kidney , actually necessary ? 
Scientific Title of Study   Conventional stent placement versus no stent placement after Ureterorenoscopic Lithotripsy for ureteric calculi –A randomized controlled study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hitesh Bohra m 
Designation  DNB TRAINEE 
Affiliation  Nazareth Hospital  
Address  Department of General Surgery , Nazareth Hospital room D3

East Khasi Hills
MEGHALAYA
793003
India 
Phone  9886168608  
Fax    
Email  bohra.hitesh1296@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Hitesh Bohra m 
Designation  DNB TRAINEE 
Affiliation  Nazareth Hospital  
Address  Department of General Surgery D-3, Nazareth Hospital

East Khasi Hills
MEGHALAYA
793003
India 
Phone  9886168608  
Fax    
Email  bohra.hitesh1296@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Hitesh Bohra m 
Designation  DNB TRAINEE 
Affiliation  Nazareth Hospital  
Address  Department of General Surgery D-3 , Nazareth Hospital

East Khasi Hills
MEGHALAYA
793003
India 
Phone  9886168608  
Fax    
Email  bohra.hitesh1296@gmail.com  
 
Source of Monetary or Material Support  
Nazareth Hospital, Arbuthnot road, Meghalaya 793003 India 
 
Primary Sponsor  
Name  Nazareth Hospital  
Address  Arbuthnot road, Laitumkhrah , Meghalaya 793003, India 
Type of Sponsor  Private hospital/clinic 
 
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 Alfred Lepcha   Nazareth Hospital   Department of General surgery , Arbuthnot road 793003, Laitumkhrah
East Khasi Hills
MEGHALAYA 
9612103757

alfredlepcha.17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 omission  After URSL procedure, patients randomized into group B, will not receive indwelling stent ( if the operating surgeon deems stent placement not mandatory based on intraoperative findings) . and at follow up , patients in both the groups will be interviewed and comparisons will be made on the quality of life, and complications arising out of stent placement and omission  
Intervention  Stent insertion  After URSL procedure, patients randomized into group A, will receive indwelling stent, and at follow up , patients in both the groups will be interviewed and comparisons will be made on the quality of life, and complications arising out of stent placement and omission DJ stent size will be based on patient habitat usually 5-6 fr silicon double J stent  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients undergoing unilateral Ureterorenoscopic lithotripsy for calculi upto 15 mm  
 
ExclusionCriteria 
Details 
1. Planned bilateral ureteroscopy.
2. Indwelling ureteral stent or percutaneous nephrostomy tube preoperatively in either kidney.
3. Anatomic abnormalities of the ipsilateral upper urinary tract (for example, horseshoe kidney, crossed fused ectopia, pelvic kidney, urinary diversion).
4. Anatomic or functional solitary kidney.
5. Planned secondary or staged ureteroscopy.
6. Pregnancy.
7 Sepsis 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the outcomes and complications of conventional stent placement versus no stent placement after Ureteroscopic Lithotripsy for ureteric calculi.
1. unexpected hospital ER visits
2. Quality of life as shown by USSQ score
3. Complications arising due to stent placement or omission  
To compare the outcomes and complications of conventional stent placement versus no stent placement after Ureteroscopic Lithotripsy for ureteric calculi.
time period would be a minimum of 4 weeks from the surgery , till end of followup , usually after 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   12/10/2026 
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="0"
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  

Title
Conventional Stent Placement Versus No Stent Placement After Ureteroscopic Lithotripsy for Ureteric Calculi A Randomized Controlled Study

Introduction
Urolithiasis affects nearly 8 percent of Indians, with some regions reporting prevalence as high as 22.4 percent. Ureteroscopic lithotripsy URSL is a common treatment, often followed by ureteral stenting to ensure postoperative ureteral patency. However, stents can cause significant discomfort and lower quality of life referred to as stent syndrome. Although professional guidelines suggest stent omission after uncomplicated URSL, over 80 percent of cases still receive stents, largely due to a lack of high quality evidence.

Aims and Objectives
The primary aim is to compare outcomes and complications of conventional stent placement versus no stent placement following uncomplicated URSL.
Objectives include:

  1. Comparing emergency department visits within 30 days post procedure.

  2. Assessing quality of life using the Ureteral Stent Symptom Questionnaire USSQ.

  3. Documenting and comparing postoperative complications in both groups.

Justification of Study
There is no prior study in India that uses the USSQ tool to guide clinical decisions on stent placement. This study aims to provide robust evidence through a randomized controlled design to optimize postoperative protocols and reduce patient morbidity.

Review of Literature
Multiple RCTs and meta analyses demonstrate that stented patients experience more pain, lower urinary tract symptoms, and longer hospital stays, without significant improvement in stone free rates or complication prevention. Studies by Reddy et al, Savic et al, Al Demour et al, and Denstedt et al consistently report improved quality of life and fewer symptoms in stentless groups.

Methodology
Design Open label, single centre RCT
Setting Nazareth Hospital, Shillong
Duration 12 months
Participants 60 adult patients 18 to 65 years undergoing unilateral URSL for stones up to 15 mm
Randomization 1 to 1 to stent Group A or no stent Group B
Inclusion Criteria Informed consent, uncomplicated URSL
Exclusion Criteria Bilateral URSL, preexisting stent, anatomical anomalies, pregnancy, staged URSL

Risks
No additional risks beyond those of standard URSL. Any intraoperative complications requiring stent placement will lead to exclusion from the study.

Outcome Measures
Primary Emergency department visits within 30 days
Secondary USSQ scores at Day 30 and postoperative complications

Statistical Analysis
Sample size 30 per group power 80 percent, alpha 0.05
Tests Chi square or Fishers exact for categorical data; t test or Mann Whitney U for continuous data
Software Stata 17
Significance p less than 0.05

National Significance
This is one of the first RCTs in India using USSQ to assess post URS outcomes. Findings could influence national surgical protocols and reduce unnecessary stent related morbidity, improving patient quality of care and resource use in urological surgery.

 
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