| CTRI Number |
CTRI/2026/02/104035 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
“Predicting Difficult Laparoscopic Gallbladder Surgery Using Clinical and Ultrasound Findings: A Prospective Observational Study in Gallstone Patients” |
|
Scientific Title of Study
|
A Prospective Observational Study to Determine Predictive Factors for Difficult Laparoscopic Cholecystectomy Using Clinico-Radiological Criteria |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aayush Shah |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Medical College |
| Address |
Department of General Suregry Datta Meghe Medical College Wanadongri Nagpur
Department of General Surgery Datta Meghe Medical College Campus Wanadongri Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9409648757 |
| Fax |
|
| Email |
acshah1202@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avinash Rinait |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Medical College |
| Address |
Department of General Surgery Datta Meghe Medical College Wanadongri Nagpur
Department of General Surgery Datta Meghe Medical College Campus Wanadongri Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
7350262569 |
| Fax |
|
| Email |
avi1234rinait@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aayush Shah |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Medical College |
| Address |
Department of General Surgery Datta Meghe Medical College Wanadongri Nagpur
Department of General Surgery Datta Meghe Medical College Wanadongri Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9409648757 |
| Fax |
|
| Email |
acshah1202@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Aayush Shah |
| Address |
Shivneri MBBS Hostel Wanadongri Nagpur Maharashtra India 441110 |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 |
| AAYUSH CHINTAN SHAH |
SHALINITAI MEGHE HOSPITAL AND RESEARCH CENTRE |
DEPARTMENT OF GENERAL SURGERY NAGPUR MAHARASHTRA
Nagpur
MAHARASHTRA |
09409648757
acshah1202@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comitte Of Datta Meghe Medical College Nagpur |
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 |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
•Adult patients 18 to 80 years diagnosed with symptomatic cholelithiasis or chronic cholecystitis
•Planned for elective laparoscopic cholecystectomy
•Provided informed consent
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome was the occurrence of difficult laparoscopic cholecystectomy, assessed intraoperatively using predefined objective criteria including operative time, adhesions, anatomical difficulty, complications, and conversion. |
The primary outcome was the occurrence of difficult laparoscopic cholecystectomy, assessed intraoperatively using predefined objective criteria including operative time, adhesions, anatomical difficulty, complications, and conversion. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="49"
Sample Size from India="49"
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)
|
20/02/2026 |
| 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
|
Gallstone disease is common worldwide, with laparoscopic cholecystectomy (LC) being the standard treatment for symptomatic cases. Although LC offers clear advantages over open surgery, 1–13% of procedures require conversion due to technical difficulties. This prospective observational study evaluates simple preoperative clinical and ultrasonographic parameters—such as prior cholecystitis attacks, leukocytosis, gallbladder wall thickness, and pericholecystic fluid—to predict difficult LC and conversion risk. Identifying high-risk patients preoperatively can improve surgical planning, patient counseling, and optimal utilization of experienced surgical teams. |