| CTRI Number |
CTRI/2022/05/042418 [Registered on: 09/05/2022] Trial Registered Prospectively |
| Last Modified On: |
08/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see renal function in patients with stone disease after removing the stone by surgery. |
|
Scientific Title of Study
|
Post Operative Renal Function In Patients With Urolithiasis: A Prospective Observational Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kothuri Sricharan Raj |
| Designation |
Registrar |
| Affiliation |
Kasturba Hospital, Manipal University |
| Address |
Room no. 14, Dept of Urology,
Kasturba Hospital,
Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9164972271 |
| Fax |
|
| Email |
charankothuri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Chawla |
| Designation |
Professor |
| Affiliation |
Kasturba Hospital, Manipal University |
| Address |
Room no. 14, Dept of Urology,
Kasturba Hospital,
Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9008002440 |
| Fax |
|
| Email |
urologyarun@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Chawla |
| Designation |
Professor |
| Affiliation |
Kasturba Hospital, Manipal University |
| Address |
Room no. 14, Dept of Urology,
Kasturba Hospital,
Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9008002440 |
| Fax |
|
| Email |
urologyarun@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba Hospital |
| Address |
Kasturba Hospital,
Manipal,
Udupi Dist,
Karnataka
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kothuri Sricharan Raj |
Kasturba Hospital |
room no 14,
dept of urology
kasturba hospital
Udupi
KARNATAKA |
9164972271
charankothuri@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 - 2 (STUDENT RESEARCH) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N209||Urinary calculus, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients being admitted with clinical diagnosis of urolithiasis for surgical management. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the improvement of renal function after intervention and follow up in treated patients. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the trend of clinical presentation, Surgical management and complications of urolithiasis. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
10/05/2022 |
| 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
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study will be conducted on patients of urolithiasis getting admitted to Kasturba Hospital, Manipal. Patients will be selected for study according to all inclusion and exclusion criteria. The method of study consists of: ï‚· Detailed history taking and a thorough physical examination as per a prepared proforma ï‚· Routine blood and urine investigations. ï‚· Specific investigations to confirm the diagnosis of Urolithiasis. ï‚· Depending on the size and site of the calculus, the appropriate treatment for the patient will be decided. The treatment includes Percutaneous nephrolithotomy (PCNL), Retrograde intrarenal surgery (RIRS), therapeutic ureteroscopy (URSL) and Cystoscopic removal of bladder calculi and urethral calculi. ï‚· Patients’ baseline renal function, comorbidities, stone parameters, and intra-operative variables will be analyzed to determine the relationship with post-operative renal function. ï‚· To study the trend of renal function in patients with urolithiasis after surgical management during follow up at post op day1 and at 4 weeks. |