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