| CTRI Number |
CTRI/2026/03/105551 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Predicting kidney stone clearance and complication rates after RIRS surgery and creating a checklist for discharging on the same day |
|
Scientific Title of Study
|
PREDICTING SFR AND COMPLICATIONS AFTER RIRS CREATING A NOMOGRAM FOR DAY CARE RIRS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
CHINMAY SANJAY JAMALE |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Hospital KMC Manipal |
| Address |
Room no 14 OPD Building Department of Urology and Renal Transplant KMC MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
8381055600 |
| Fax |
|
| Email |
chinmay.jamale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARUN CHAWLA |
| Designation |
PROFESSOR |
| Affiliation |
Kasturba Hospital KMC Manipal |
| Address |
Room number 14 OPD Building Department of Urology and Renal Transplant KMC MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9008002440 |
| Fax |
|
| Email |
arun.chawla@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
CHINMAY SANJAY JAMALE |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Hospital KMC Manipal |
| Address |
Room no 14 OPD Building Department of Urology and Renal Transplant KMC MANIPAL
KARNATAKA
576104
India |
| Phone |
8381055600 |
| Fax |
|
| Email |
chinmay.jamale@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
CHINMAY SANJAY JAMALE |
| Address |
Room no 14 OPD Building Department of Urology and Renal Transplant KMC MANIPAL
|
| Type of Sponsor |
Other [self] |
|
|
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 |
| CHINMAY SANJAY JAMALE |
KASTURBA HOSPITAL |
Room number 14 OPD Building Department of Urology and Renal Transplant
Udupi
KARNATAKA |
8381055600
chinmay.jamale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBAMEDICALCOLLEGEANDKASTURBAHOSPITALINSTITUTIONALETHICSCOMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Any age needing RIRS
Normal kidney anatomy
Residing within a 20 km radius of at least a secondary healthcare center
Stone size greataer than 3 cm in single dimension |
|
| ExclusionCriteria |
| Details |
Anatomical abnormalities
Bilateral RIRS in the same sitting
Charleson co-morbidity score greater than 3
Retrograde intrarenal stone RIRS score greater than 6
Operative time more than 90 minutes
Pelvicalyceal system perforation
Post Ureteroscopic Lesion Scale PULS greater than 2
Post operative exclusive criteria assessed 6 hours post procedure
Hemodynamic instability Heart rate greater than 100 beats per minute respiratory rate more than 20 breaths per minute and systolic blood pressure less than 100 mm of Hg
Persistent fever 100 degree Fahrenheit
Pain visual analogue score VAS greater than 4
Persistent significant visible hematuria as assessed by the operating surgeon |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary objective predicting SFR and complications after RIRS
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Creating a nomogram for daycare RIRS |
18 months |
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
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
|
N/A |
|
Date of First Enrollment (India)
|
26/03/2026 |
| 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="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
|
RIRS is a commonly used minimally invasive procedure to remove stones from the kidney In many hospitals this operation can now be done as a day care procedure meaning patients are admitted and discharged within 24 hours of admission However not all patients achieve a completely stone free result and some may develop complications By studying different patient stone and surgery factors it can help to create a simple tool called a nomogram that will help doctors predict before surgery the chances of complete stone clearance and any possible complications This may improve patient counselling decision making and safety |