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CTRI Number  CTRI/2024/11/077457 [Registered on: 28/11/2024] Trial Registered Prospectively
Last Modified On: 27/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Analytical study 
Study Design  Other 
Public Title of Study   Role of Artificial Intelligence in laparoscopic cholecystectomy surgery 
Scientific Title of Study   Development of an artificial neural network/ convoluted neural network and deep learning based predictive model of difficulty grades of laparoscopic cholecystectomy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepjyoti Chaudhuri 
Designation  Junior Resident, Dept of Surgery 
Affiliation  Armed Forces Medical College, Pune, India 
Address  Department of Surgery First Floor, Main Building Armed Forces Medical College Pune, Solapur - Pune Highway, near Race Course, Wanowrie, Pune

Pune
MAHARASHTRA
411040
India 
Phone  9804704087  
Fax    
Email  drdeepjyoti2012@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Gp Capt Ameet Kumar 
Designation  Professor, Department of Surgery 
Affiliation  Armed Forces Medical College, Pune, India 
Address  Department of Surgery First Floor, Main Building Armed Forces Medical College Pune, Solapur - Pune Highway, near Race Course, Wanowrie, Pune

Pune
MAHARASHTRA
411040
India 
Phone  6002092231  
Fax    
Email  ameetsurg@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anumoy Ghosh 
Designation  Asst Prof Grade-1 
Affiliation  NIT Mizoram 
Address  Department of Electronics and Communication Engineering NIT Mizoram, Chaltlang Aizawl

Aizawl
MIZORAM
796012
India 
Phone  6009267471  
Fax    
Email  anumoy.ece@nitmz.ac.in  
 
Source of Monetary or Material Support  
NIT Mizoram Aizawl, India. Pin - 796012 
 
Primary Sponsor  
Name  Armed Forces Medical College 
Address  AFMC Pune Maharashtra - 411040 
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 Deepjyoti Chaudhuri  Armed Forces Medical College, Pune  Department of Surgery Armed Forces Medical College Pune, Solapur - Pune Highway, near Race Course, Wanowrie, Pune - 411040
Pune
MAHARASHTRA 
9804704087

drdeepjyoti2012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe, Armed Forces Medical College, Punee, AFMC Pune  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  AI predictor model  Difficulty grade of laparoscopic Cholecystectomy is assessed based on clinico-demographic-radiologic data, which the AI MODEL will interpret and assign an surgical operative difficulty grade. 
Comparator Agent  Randhawa Pujahari scale  The surgical difficulty grade will be predicted using the same data of the test population using the Randhawa Pujahari scale  
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All patients undergoing laparoscopic cholecystectomy at AFMC Pune 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prediction of Difficulty Grades of surgery for laparoscopic cholecystectomy  at the end of the study 
 
Secondary Outcome  
Outcome  TimePoints 
Variation of difficulty grades with age, gender, prior abdominal surgery history, gall bladder characteristics like wall thickness, pericholecystic fluids  At the end of each case 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   09/12/2024 
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="0"
Months="4"
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  

Background: Laparoscopic cholecystectomy, a routinely performed high volume surgical procedure, is a suitable surgical procedure for the application of machine learning techniques, using analysis of ultrasound images. However, the adoption of AI in surgical practice has been limited by factors such as surgeon awareness, complex algorithms, and the lack of synchronized preoperative ultrasound and intra-operative images.

 

The Study:   This pilot study aims to investigate the role of artificial intelligence (AI) in predicting difficulty grades for Laparoscopic Cholecystectomy whereby it is  hypothesized that AI-based analysis of preoperative ultrasound images can predict operative difficulty by training a computer system with both preoperative and intra-operative images.

 

Aims & Objectives: The research objectives include collecting and feeding data of ultrasound images to develop an AI algorithm in the first phase, and testing the algorithm by predicting difficulty grades based on preoperative ultrasound images in the second phase. Being conducted at a tertiary care teaching hospital, approximately 400 cases of laparoscopic cholecystectomy will be analyzed.

 

Methodology: Involves creating a data pool of preoperative and intra-operative images, training a machine learning platform using artificial/ convolutional neural networks, and subsequently assessing the accuracy of preoperative ultrasound findings in predicting operative difficulty. 

 

It is expected to establish the potential role of AI-based image analysis in laparoscopic cholecystectomy and pave the way for future research in this field. The findings will contribute to evidence-based medicine and have implications for clinical practice, providing a foundation for further exploration and development of AI tools in surgical prediction.

 
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