| CTRI Number |
CTRI/2024/08/072276 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observation study to predict the renal function of remaining kidney and outcomes in patient undergoing radical nephrectomy |
|
Scientific Title of Study
|
A Prospective Observational study to estimate split renal function and predict
functional outcomes after radical nephrectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swarnendu Mandal |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Science, Bhubaneswar |
| Address |
Dept of Urology , 2nd Floor , AIIMS Bhubaneswar Kendrapara ORISSA 751019 India
Kendrapara
ORISSA
751019
India
Kendrapara
ORISSA
751019
India |
| Phone |
8447562972 |
| Fax |
|
| Email |
urol_swarnendu@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Saharsh Ambade |
| Designation |
Senior resident |
| Affiliation |
All India Institute Of Medical Science, Bhubaneswar |
| Address |
Dept of Urology , 2nd Floor , AIIMS Bhubaneswar Kendrapara ORISSA 751019 India
Kendrapara
ORISSA
751019
India
Kendrapara
ORISSA
751019
India |
| Phone |
8586097324 |
| Fax |
|
| Email |
ambade3582@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saharsh Ambade |
| Designation |
senior resident |
| Affiliation |
All India Institute Of Medical Science, Bhubaneswar |
| Address |
Department of Urology, 2nd Floor. AIIMS Bhubaneswar Kendrapara ORISSA 751019 India
Kendrapara
ORISSA
751019
India
Kendrapara
ORISSA
751019
India |
| Phone |
8586097324 |
| Fax |
|
| Email |
ambade3582@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Urology, 2nd Floor. AIIMS Bhubaneswar
Kendrapara
ORISSA
751019
India |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Saharsh Ambade |
All India Institute Of Medical Sciences , Bhubaneswar |
Department of urology, 2nd floor , AIIMS, Bhubaneswar , Patrapada , Odisha
Kendrapara
ORISSA
Kendrapara
ORISSA |
8586097324
ambade3582@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing Radical nephrectomy
2.Written informed consent
|
|
| ExclusionCriteria |
| Details |
1.ASA Grade ≥ 3 (Patients Unfit for Surgery)
2.Patient undergoing cytoreductive nephrectomy
3.Patient undergoing simple/donor/partial nephrectomy
4.Patient with preoperative CKD
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate split renal function and predict functional outcomes after radical nephrectomy using Parenchymal volume analysis, creatinine , EGFR. |
Baseine
1 month
3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
20/08/2024 |
| 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
|
Patient undergoing radical Nephrectomy for RCC tumors have imminent risk of decline in new baseline glomerular filtration rate. This study aims to develop nomogram to predict outcomes after
radical nephrectomy using Parenchymal volume analysis, creatinine , EGFR that can
have significant clinical implications for RCC management and patient
counseling. |