NCT06732271

Brief Summary

Objective: Critical view of safety (CVS) is a successful technique to reduce bile duct injury during laparoscopic cholecystectomy (LC). We aimed to create a deep learning-based quality control model for LC and reduce the learning curve for junior surgeons, which would automatically assess whether surgeons are CVS conscious during procedures.Methods: We retrospectively collected 308 LC videos from public datasets (Cholec80, Endoscapes) and Sun Yat-sen Memorial Hospital. Video frames were labeled using binary classification and feature optimization methods, such as black border clipping and sliding windows. Two neural networks, ResNet-50 and EfficientNetV2-S, were trained and evaluated based on F1 scores and accuracy. Additionally, We created an online CVS recognition system (LC-Smart), tested it using 171 films from two hospitals, and compared the results to two local senior doctors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
308

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2024

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2024

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

1 month

First QC Date

December 9, 2024

Last Update Submit

December 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • the surgical time

    Nov/2023-Nov/2024

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

people with laparoscopic cholecystectomy

You may qualify if:

  • complete video data with no missing footage;
  • surgical procedure identified as laparoscopic cholecystectomy;
  • full visibility of the surgical area in the video;
  • successful completion of the procedure;
  • absence of significant anatomical variations
  • video resolution no less than 720×560.

You may not qualify if:

  • substantial intraoperative adhesions
  • a history of previous abdominal or pelvic procedures
  • a conversion to open surgery during the procedure
  • significant bleeding that obscured structural identification.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Memorial Hospital,SUn Yat-sen UNiversity

Guangzhou, Guangdong, 510220, China

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2024

First Posted

December 13, 2024

Study Start

October 24, 2024

Primary Completion

November 24, 2024

Study Completion

November 30, 2024

Last Updated

December 13, 2024

Record last verified: 2024-12

Locations