FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091693 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 24/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A trial to compare safety and efficacy of Laparoscopic and Robotic approaches for patients undergoing surgery for adrenal gland lesions. 
Scientific Title of Study   Comparison of clinical outcomes in Laparoscopic versus Robotic adrenalectomy for benign and malignant adrenal diseases: A randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kunal Soni  
Designation  Junior Resident  
Affiliation  Kunal Soni  
Address  Room No. 310, A3B3 Ward, Department of Surgical Disciplines, AIIMS

New Delhi
DELHI
110029
India 
Phone  9599416727  
Fax    
Email  kunalsoni1234@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR. PIYUSH RANJAN 
Designation  Professor  
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No. 404, 4th Floor, Department of Surgical Disciplines, AIIMS, New Delhi
Ansari Nagar, New Delhi-110029
New Delhi
DELHI
110029
India 
Phone  9971085243  
Fax    
Email  drpmishra28@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kunal Soni  
Designation  Junior Resident  
Affiliation  Kunal Soni  
Address  Room No. 310, A3B3 Ward, Department of Surgical Disciplines, AIIMS

New Delhi
DELHI
110029
India 
Phone  9599416727  
Fax    
Email  kunalsoni1234@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Science, New Delhi 
 
Primary Sponsor  
Name  Kunal Soni 
Address  Room No. 310, A3B3 Ward, Department of Surgical Disciplines, AIIMS  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Kunal Soni  All India Institute of Medical Sciences  Wards,Department of Surgical Disciplines
South
DELHI 		 9599416727

kunalsoni1234@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for PG Research  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 Adrenalectomy   This study will help us to realize which minimal access approach (robotics or Laparoscopic ) is better for patients to have a better clinical outcome postoperatively This study will help us in determining the ease of doing surgery by surgeon and possibility of conversion to open procedure 
Intervention  Robotic Adrenalectomy   This study will help us to realize which minimal access approach (robotics or Laparoscopic ) is better for patients to have a better clinical outcome postoperatively This study will help us in determining the ease of doing surgery by surgeon and possibility of conversion to open procedure  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age more than 18 years 
 
ExclusionCriteria 
Details  Age below 18 yrs
Refusal to give consent
Patients not fit for general anesthesia and
surgical positioning
History of previous abdominal Surgeries
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the clinical outcomes (Safety & Efficacy) between robotic and laparoscopic adrenalectomy in benign and malignant adrenal lesions.  Safety and efficacy will be assessed at baseline after surgery and at 2 weeks and 6 weeks after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the ease of doing the procedure by the surgeon between robotic & laparoscopic adrenalectomy.  At baseline, just after the surgery 
To compare the robotic & laparoscopic adrenalectomy in terms of conversion to open
adrenalectomy.
 		 baseline just after the surgical procedure  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 2/ Phase 3 
Date of First Enrollment (India)   04/08/2025 
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 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  

This study is a Randomised Controlled Trial to compare the clinical outcomes (Safety & Efficacy) between robotic and laparoscopic adrenalectomy in benign and malignant adrenal lesions and also to assess the  ease of doing the procedure by the surgeon between robotic and laparoscopic adrenalectomy and conversion to open in each approach.  This will help us to realize which minimal access approach (robotics or Laparoscopic ) is better for patients to have a better clinical outcome postoperatively and also to determine the ease of doing surgery by surgeon and possibility of conversion to open procedure.

 
Close