Improving Surgeon Performance Measures for Robot-Assisted Surgery

May 2, 2024 updated by: Memorial Sloan Kettering Cancer Center

Generalized Robotic Skills Assessment Using Machine Learning-Based Analysis Across Multiple Surgical Specialties

The purpose of this study is to develop new tools to understand surgeon performance to improve surgical training and participant outcomes after surgery.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center (All protocol activites)
      • Rockville Centre, New York, United States, 11553
        • Memorial Sloan Kettering Nassau (Limited protocol activites)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Surgeons who meet the inclusion criteria will be approached by the study team for participation in this study.

Description

Inclusion Criteria:

  • Surgeons who perform robotic surgery for candidate procedures
  • Surgeons who perform candidate procedures that are frequently performed by at least three surgeons (to ensure the ability to make adequate comparisons)
  • Surgeons who agree to participate in the study

Exclusion Criteria:

  • Surgeons who decline to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Robotic surgeons
Participants will be robotic surgeons in urologic, gynecologic, colorectal, hepatobiliary, gastric, and thoracic surgery
Procedure: Robotic Surgery
Surgeons will perform and participants will undergo robotic surgery according to the standard of care. No additional interventions will be performed on participating participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of Automated Performance Metrics to surgeon experience
Time Frame: Up to 2 years

For the primary objective, we will capture Automated Performance Metrics/APMs and will determine the association between these and other metrics and surgeon experience, which will be used to construct validation.

APMs that will be used in the study:

Time Metrics

Camera Metrics

Instrument Metrics

System Metrics

Articulation Metrics
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Alvin Goh, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2023

Primary Completion (Estimated)

August 24, 2026

Study Completion (Estimated)

August 24, 2026

Study Registration Dates

First Submitted

August 25, 2023

First Submitted That Met QC Criteria

September 7, 2023

First Posted (Actual)

September 14, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 23-094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surgery

Clinical Trials on Robotic Surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe