| 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
|
|
|
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
|
|
|
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: -
Comparing emergency department visits within 30 days post procedure. -
Assessing quality of life using the Ureteral Stent Symptom Questionnaire USSQ. -
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. |