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CTRI Number  CTRI/2026/04/107678 [Registered on: 07/04/2026] Trial Registered Prospectively
Last Modified On: 23/01/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective Study 
Study Design  Other 
Public Title of Study   A Study Exploring Health Issues and Recovery Challenges in Participants Undergoing Gallbladder Surgery 
Scientific Title of Study   IMPACT CHOLE: Assessment of Morbidity and Burden of Illness through a Tracking Initiative in a Prospective, Observational Study of Cholecystitis 
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 Virinder Kumar Bansal 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Surgical Disciplines, Room No. 405, 4th Floor, New Surgical Block, AIIMS, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  01126588500  
Fax    
Email  drvkbansal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Akhil Dahiya 
Designation  Head, Department of Clinical and Medical Affairs 
Affiliation  Intuitive Surgical India Pvt. Ltd. 
Address  6th Floor, St Andrews (Signature Block), Embassy Golf Link Business Park, off Intermediate Ring Road, Domlur, Challaghatta Village, Varthur Hobli, Bangalore

Bangalore
KARNATAKA
560071
India 
Phone  08045505100  
Fax    
Email  akhil.dahiya@intusurg.com  
 
Details of Contact Person
Public Query  
Name  Dr Akhil Dahiya 
Designation  Head, Department of Clinical and Medical Affairs 
Affiliation  Intuitive Surgical India Pvt. Ltd. 
Address  6th Floor, St Andrews (Signature Block), Embassy Golf Link Business Park, off Intermediate Ring Road, Domlur, Challaghatta Village, Varthur Hobli, Bangalore

Bangalore
KARNATAKA
560071
India 
Phone  08045505100  
Fax    
Email  akhil.dahiya@intusurg.com  
 
Source of Monetary or Material Support  
Intuitive Surgical India Pvt. Ltd. 6th Floor, St Andrews (Signature Block), Embassy Golf Link Business Park, off Intermediate Ring Road, Domlur, Challaghatta Village, Varthur Hobli, Bangalore – 560071, Karnataka, India 
 
Primary Sponsor  
Name  Intuitive Surgical India Pvt. Ltd. 
Address  6th Floor, St Andrews (Signature Block), Embassy Golf Link Business Park, off Intermediate Ring Road, Domlur, Challaghatta Village, Varthur Hobli, Bangalore – 560071, Karnataka, India 
Type of Sponsor  Other [Medical Device Company] 
 
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 Virinder Kumar Bansal  All India Institute of Medical Sciences  Department of Surgical Disciplines, New Surgical Block, AIIMS, Ansari Nagar, New Delhi- 110029
South
DELHI 		 01126588500

drvkbansal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K810||Acute cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Adult patients (18 years or more) undergoing cholecystectomy for cholecystitis/gallstone disease.
2. The subject is scheduled to undergo cholecystectomy for acute cholecystitis classified as grade I or II, as assessed by the physician in accordance with the Tokyo guidelines. 
 
ExclusionCriteria 
Details  1. The subject has a contraindication to general anesthesia or surgical procedures.
2. The subject has been taking daily pain medications for more than 6 weeks.
3. The subject is scheduled to undergo a concomitant procedure.
4. The subject has a known bleeding or coagulation disorder.
5. The subject is pregnant or suspected to be pregnant.
6. The subject has a psychological or psychiatric disorder, or a severe systemic illness that may hinder compliance with study requirements or the ability to provide informed consent.
7. The subject is currently enrolled in another interventional or investigational research study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the change in Health-Related Quality of Life (HRQoL), as measured by the EQ-5D-3L index score, from pre-operative baseline to postoperative day 30 between patients undergoing laparoscopic or robotic-assisted cholecystectomy.  At baseline, and at Day 3 (+1) day, day 7 (+1) day, Day 14 (+3) days, and Day 30 (+5) days post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To compare perioperative outcomes: operative time, estimated blood loss, conversion to open surgery, intraoperative complications, postoperative complications, post-anesthesia care unit (PACU) time, Intensive Care Unit (ICU) stay, & length of hospital stay (LOS).  At discharge 
To compare patient-reported pain intensity as assessed by the Numeric Rating Scale (NRS) at predefined time points  At baseline, & at 6, 12, 24 hours, day 3, & day 7 post surgery 
To compare cumulative analgesic consumption during the first 7 postoperative days.  At Day 7 post surgery 
To compare time to return to activities of daily living & return to work.  At day 3, 7 & 14 post surgery.  
To collect optional cost data to evaluate direct treatment costs, costs of adverse event (AE) management, readmissions & reoperations & perform exploratory cost-effectiveness analyses (e.g., cost per QALY gained using EQ-5D utility values).  At baseline & at 30 days post surgery.  
To document survival status, EQ-5D-3L, bile duct injury, port side hernia, and any costs related to readmission and reoperation.  3, 6, and 12 months post surgery 
 
Target Sample Size   Total Sample Size="218"
Sample Size from India="218" 
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)   15/05/2026 
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   Cholecystectomy is one of the most commonly performed general surgical procedures. The purpose of this study is to evaluate the quality of life, pain and cost outcomes following laparoscopic cholecystectomy (LC) or robotic-assisted cholecystectomy (RAC). The goal of this real-world observational study is to generate essential data on quality of life and pain outcomes following LC or RAC. 
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