| CTRI Number |
CTRI/2025/12/098354 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of 3D Virtual Reality Technology on Outcomes of Robotic-Assisted Partial Nephrectomy. |
|
Scientific Title of Study
|
A Prospective Study on the Impact of Three-Dimensional Virtual Reality Models on Surgical Planning and Clinical Outcomes in Robotic-Assisted Partial 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 |
DR DHRUVIN GANATRA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of general surgery Post Graduate Institute of Medical Education and Research madhya marg sector 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7984960325 |
| Fax |
|
| Email |
dhruvinganatra25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHANKY SINGH |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of urology Post Graduate Institute of Medical Education and Research madhya marg sector 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8837671948 |
| Fax |
|
| Email |
shankydt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DHRUVIN GANATRA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of general surgery Post Graduate Institute of Medical Education and Research madhya marg sector 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7984960325 |
| Fax |
|
| Email |
dhruvinganatra25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research Chandigarh |
|
|
Primary Sponsor
|
| Name |
DR DHRUVIN GANATRA |
| Address |
Department of general surgery Post Graduate Institute of Medical Education and Research madhya marg sector 12 Chandigarh 160012 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR SHANKY SINGH |
Department of urology Post Graduate Institute of Medical Education and Research madhya marg sector 12 Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SHANKY SINGH |
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH |
Department of urology,Postgradu Institute of medical and research Chandigarh Madhya Marg sector 12 Chandigarh 160012
Chandigarh
CHANDIGARH |
8837671948
shankydt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C649||Malignant neoplasm of unspecifiedkidney, except renal pelvis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Preoperative Planning without 3D VR (Conventional Imaging-Based Planning) |
Preoperative planning based on routine 2D CT imaging using axial, coronal, and sagittal views without the use of 3D virtual reality reconstruction. |
| Intervention |
Three-Dimensional Virtual Reality–Assisted Surgical Planning for Robotic-Assisted Partial Nephrectomy |
Creation of a patient-specific 3D VR renal model from preoperative CT imaging.
The surgeon reviews and interacts with the VR model for tumor anatomy assessment, resection planning, RENAL score analysis, vascular mapping, and approach strategy prior to robotic-assisted partial nephrectomy. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients who are giving informed consent
2 Patients undergoing robotic assisted partial nephrectomy
3 T1a and selective T1b ranal mass low to intermediate risk nephrometry score
|
|
| ExclusionCriteria |
| Details |
1 Patients not willing for consent
2 Patients without preoperative CT MRI or IVP
3 Pregnant women
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the change in operative time for robotic assisted surgery when surgeons reviewed three dimensional virtual reality model |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 change surgical planning
2 reduce estimated blood loss
3 reduce clamp time
4)reduce average hospital stay
|
1.5 years |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
13/12/2025 |
| 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="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
|
This is randomised controlled trial to see effect of three dimensional virtual reality model surgical outcome and planning of robotic assisted partial nephrectomy to compare change in operative time for robotic assisted surgery when surgeon reviewed three dimensional virtual reality model sample size is 52 conduct in India |