| CTRI Number |
CTRI/2025/03/083724 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Analysis between various Stone scores for PCNL and creating a new score |
|
Scientific Title of Study
|
Evaluation of various stone-scoring systems Guys stone score STONE Nephrolithometry Clinical Research Office of Endourological Society CROES nomogram and Seoul National University Renal Stone Complexity S ReSC score for creating a new nomogram for predicting stone free rates SFR and complications after percutaneous nephrolithotomy PCNL a prospective observational 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 |
SHUBHAM SINGH |
| Designation |
Senior resident |
| Affiliation |
KMC Manipal |
| Address |
Room no 14, urology OPD , !st floor BALIGA black, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9413235256 |
| Fax |
|
| Email |
Shubham21singh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. SUNIL B PILLAI |
| Designation |
PROFESSOR AND HOD DEPT OF UROLOGY |
| Affiliation |
|
| Address |
Room no 14, urology OPD , 1st floor BALIGA black, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9731855209 |
| Fax |
|
| Email |
sunil.pillai@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
SHUBHAM SINGH |
| Designation |
Senior resident - Dept of urology and renal transplantation, KMC Manipal |
| Affiliation |
KMC Manipal |
| Address |
Room no 14, urology OPD , !st floor BALIGA black, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9413235256 |
| Fax |
|
| Email |
Shubham21singh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College (KMC), Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 57610
INDIA |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Kasturba Medical College Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104 |
| Type of Sponsor |
Private medical college |
|
|
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 Shubham singh |
KASTURBA MEDICAL COLLEGE MANIPAL |
Room no 14, UROLOGY OPD, 1st floor, BALIGA block, KMC Manipal, Tiger circle road, madhav nagar, eshwar nagar, manipal
Udupi
KARNATAKA |
9413235256
Shubham21singh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and kasturba hospital institutional ethics committee |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All consenting adults of any gender having renal calculi 2cm undergoing PCNL |
|
| ExclusionCriteria |
| Details |
1. Patient with chronic renal failure
2. Patients with indwelling stents and nephrostomy tubes. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO compare all four scoring systems for predicting stone free rates (SFR) and complications after percutaneous nephrolithotomy (PCNL) over a follow up period of 1 month post discharge |
a follow up period of 1 month post discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare different scoring systems to predict SFR
2. To create a novel nomogram to predict stone free rates in patients undergoing PCNL |
A follow up period of 1 month post discharge |
|
|
Target Sample Size
|
Total Sample Size="164"
Sample Size from India="164"
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)
|
15/04/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
Global disease burden of urolithiasis - 1394/100,000 population
Stone burden in South-east asia - 1652/100,000 population
Disease burden in india (2019) - 1821/100,000 population
The present lack of a standardized scoring systems for predicting stone free rates and complications necessitates this study |