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CTRI Number  CTRI/2026/02/103212 [Registered on: 06/02/2026] Trial Registered Prospectively
Last Modified On: 29/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Evaluating a pre-operative score to predict difficulty of laparoscopic cholecystectomy 
Scientific Title of Study   Evaluation of Difficult Laparoscopic Cholecystectomy Using A Pre-Operative Scoring System 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aabhas Katia 
Designation  Junior Resident 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department Of Surgery, Level III, D-Block, Government Medical College and Hospital, Sector 32, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9356295353  
Fax    
Email  aabhaskatia@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh Kumar Bansiwal 
Designation  Professor 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department Of Surgery, Level III, D-Block, Government Medical College and Hospital, Sector 32, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121566  
Fax    
Email  rajbansiwal_72@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Aabhas Katia 
Designation  Junior Resident 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department Of Surgery, Level III, D-Block, Government Medical College and Hospital, Sector 32, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9356295353  
Fax    
Email  aabhaskatia@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Government Medical College and Hospital Chandigarh 
Address  Sector 32, Chandigarh, India, 160030 
Type of Sponsor  Government medical college 
 
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 Aabhas Katia  Government Medical College and Hospital  Department Of Surgery, Level III, D-Block, Government Medical College and Hospital, Sector 32, Chandigarh, 160030
Chandigarh
CHANDIGARH 
9356295353

aabhaskatia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE (GMCH, Chandigarh)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients above 18 years undergoing elective laparoscopic cholecystectomy. 
 
ExclusionCriteria 
Details  Emergency cholecystectomy (e.g., perforated gallbladder, empyema), Patients with known gallbladder malignancy, Patients undergoing open cholecystectomy primarily, Patients with liver cirrhosis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess correlation between preoperative and intraoperative scores with surgical difficulty  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
To review the components & scoring criteria of Modified Randhawa & Pujahari’s Preoperative Predictive Scale for assessing the difficulty of laparoscopic
cholecystectomy.
To evaluate the clinical utility of using Modified Randhawa & Pujahari’s scale for surgical planning. 
2 years 
 
Target Sample Size   Total Sample Size="125"
Sample Size from India="125" 
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)   24/02/2026 
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="2"
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  
This study focuses on improving the safety and planning of gallbladder surgery, known as laparoscopic cholecystectomy. While most of these surgeries are straightforward, a significant number become difficult because of factors like inflamed tissue, prior surgeries, or other health issues. These difficulties can make the operation take longer, increase complications, or require switching to a larger open surgery. The study tests a scoring system that uses patient history, physical findings, and ultrasound results to predict in advance which cases are likely to be challenging. By knowing this ahead of time, the medical team can plan more effectively, allocate the needed resources, prepare for possible difficulties, and discuss risks more clearly with patients. This research, conducted at Government Medical College and Hospital, Chandigarh, compares the predictions of the scoring system with the actual experience during surgery. The ultimate aim is to make gallbladder surgery safer for patients by helping doctors anticipate and manage difficult cases before they start.
 
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