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CTRI Number  CTRI/2025/07/090120 [Registered on: 03/07/2025] Trial Registered Prospectively
Last Modified On: 02/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparison between laparoscopic partial nephrectomy and robotic partial nephrectomy 
Scientific Title of Study   A Randomized controlled trial comparing laparoscopic partial nephrectomy to robotic assisted partial nephrectomy- Short-term outcomes 
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 Gaurav Jalendra 
Designation  DrNB Resident, Dept. of Urology and renal transplant 
Affiliation  Rukmani Birla Hospital, Jaipur 
Address  B-40, Basement floor, Rukmani Birla Hospital, Jaipur

Jaipur
RAJASTHAN
302018
India 
Phone  09950152460  
Fax    
Email  gauravjalendra004@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Devendra Kumar Sharma 
Designation  Director, Urology and Renal transplant 
Affiliation  Rukmani Birla Hospital, Jaipur 
Address  B-40, Basement floor, Rukmani Birla Hospital, Jaipur

Jaipur
RAJASTHAN
302018
India 
Phone  09828280909  
Fax    
Email  lakheri@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gaurav Jalendra 
Designation  DrNB Resident, Dept. of Urology and renal transplant 
Affiliation  Rukmani Birla Hospital, Jaipur 
Address  B-40, Basement floor, Rukmani Birla Hospital, Jaipur

Jaipur
RAJASTHAN
302012
India 
Phone  09950152460  
Fax    
Email  gauravjalendra004@gmail.com  
 
Source of Monetary or Material Support    
Primary Sponsor  
Name  Dr Gaurav Jalendra 
Address  B-40, Basement floor, RBH, Jaipur, Rajasthan, India- 302018 
Type of Sponsor  Other [Self ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gaurav Jalendra  Rukmani Birla Hospital  B-40, Basement floor, Department of Urology and renal transplant sciences
Jaipur
RAJASTHAN 		 09950152460

gauravjalendra004@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of the Institutional Ethics Committee, Rukmani Birla Hospital, A Unit of CMRI, Gopalpura Bypass Road, Gopalpura, Jaipur-302017 Rajasthan, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Laparoscopic  renal tumor will be excised with laparoscopic interventions 
Intervention  Robotic Assisted  renal tumor will be excised with robotic interventions 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. ASA/ Eligible to undergo MIS.
2. Give written and informed consent
 
 
ExclusionCriteria 
Details  1. Coagulopathy
2. Metastatic disease
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Compare WIT (warm ischemia time) between LPN and RPN  3 month 
 
Secondary Outcome  
Outcome  TimePoints 
Compare intra-operative parameters between LPN & RPN.
Compare post-operative parameters between LPN & RPN.
Compare pathological outcome between LPN & RPN.
 		 3 month 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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   Phase 3 
Date of First Enrollment (India)   14/07/2025 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [gauravjalendra004@gmail.com].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 01-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a randomized, parallel group, single centre trial comparing the laparoscopic and robotic partial nephrectomy in 64 patients with renal mass that will be conducted in single centre in India. The primary outcome measures will be Warm ischaemia time. The secondary outcomes will be intra-operative, post-operative and pathological outcomes at 3 month. 
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