| 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
|
|
|
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
|
|
|
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
|
|
|
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. |