NCT06612606

Brief Summary

The goal of this observational study is to explore how pretrained artificial intelligence (AI) models, trained on preclinical data, can improve the accuracy of action recognition and skills assessment in robot-assisted surgery (RAS) in urological patients by the use of transfer learning. The main questions it aims to answer are:

  • Can pretrained AI models accurately assess action recognition and skills assessment in clinical surgeries?
  • How do different training approaches of transfer learning affect the performance of the AI models? A baseline model developed from scratch using clinical data will be compared to pretrained models that are (1) directly applied to clinical data (2) fine-tuned by training only some layers of the AI model, and (3) fully retrained to see if these approaches improve performance. Participants who are robot surgeons will:
  • Undergo RAS procedures on patients, with no intervention, where video data will be collected for later action recognition and skills assessment.
  • Contribute to model training and evaluation through clinical dataset integration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2023

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

4 days

First QC Date

September 22, 2024

Last Update Submit

September 24, 2024

Conditions

Keywords

deep learningtransfer learningrobot surgerysurgical assessment

Outcome Measures

Primary Outcomes (6)

  • Accuracy of action recognition using clinical data from scratch

    Accuracy of the deep learning algorithm for action recognition, when training the model from scratch using clinical data from robot surgical procedures.

    From start to end of a the robot surgical procedure that is being assessed in terms of action recognition.

  • Accuracy of skills assessment using clinical data from scratch

    Accuracy of the deep learning algorithm for skills assessment, when training the model from scratch using clinical data from robot surgical procedures.

    From start to end of a the robot surgical procedure that is being assessed in terms of action recognition.

  • Accuracy of action recognition using the pretrained network directly on clinical data

    Accuracy of the pretrained deep learning algorithm for action recognition, when using the model directly on clinical data from robot surgical procedures.

    From start to end of a the robot surgical procedure that is being assessed in terms of action recognition.

  • Accuracy of skills assessment using the pretrained model directly on clinical data

    Accuracy of the pretrained deep learning algorithm for skills assessment, when using the model directly on clinical data from robot surgical procedures.

    From start to end of a the robot surgical procedure that is being assessed in terms of skills assessment.

  • K fold accuracies for action recognition and skills assessment for the complete retraining of the pretrained network.

    K fold cross-validation accuracies when retraining the complete pretrained model on the clinical data for both action recognition and skills assessment.

    From the start to the end of the clinical procedures.

  • K fold accuracies for action recognition and skills assessment for the partial retraining of the pretrained network.

    K fold cross validation accuracies for action recognition and skills assessment for the retraining of the LSTM and dense layers of the pretrained network using clinical data.

    From the start to the end of the clinical procedures.

Secondary Outcomes (4)

  • Weighted recall/sensitivity, precision and F1 score for action recognition of the clinical network trained from scratch

    From start to end of a the robot surgical procedure that is being assessed in terms of action recognition.

  • Weighted recall/sensitivity, precision and F1 score for Skills Assessment of the clinical network trained from scratch

    From start to end of a the robot surgical procedure that is being assessed in terms of skills assessment..

  • Predictive certainty of the action recognition and skills assessment of the network trained from scratch on the clinical data.

    From the start to the end of the clinical procedures.

  • Predictive certainty of the action recognition and skills assessment of the network partially retrained network.

    From the start to the end of the clinical procedures.

Study Arms (2)

Experienced robot surgeons

Robot surgeons with 100 or more performed robot surgical cases.

Other: observational study

Novice robot surgeons

Robot surgeons with less than 100 performed robot surgical cases.

Other: observational study

Interventions

This was an observational study with no intervention.

Experienced robot surgeonsNovice robot surgeons

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of robot surgeons who where either experienced or novice (being specialized doctors undergoing surgical fellowship to become robot surgeons). All procedures where robot-assisted procedures done on patients, who were admitted for treatment at the urological department. The patients also gave their consent regarding data collection. However, the real participant where the robot surgeons.

You may qualify if:

  • Robot surgeons who are experienced with more than 100 cases.
  • Robot surgical fellows with less than 100 cases.
  • Robot surgeons who worked at the urological department of Aalborg University Hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of urology, Aalborg University Hospital

Aalborg, North Jutland, 9000, Denmark

Location

Related Links

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 22, 2024

First Posted

September 25, 2024

Study Start

May 22, 2023

Primary Completion

May 26, 2023

Study Completion

May 26, 2023

Last Updated

September 26, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

The IPD will be shared as anonymous and GDPR secure data on an open access website. The data will be shared as the anonymized footage of the surgical procedures that the participants made.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
The IPD and supporting information will be available from the time of submission to the journal, and will be available for an unlimited amount of time.
Access Criteria
Everyone who has access to the open source website of GitHub will be able to access the data. And anyone who will have access to the journal will have access to the supporting information.

Locations