Improving Surgeon Performance Measures for Robot-Assisted Surgery

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT06037837

Collaborator

(none)

1,000

Enrollment

Locations

Anticipated Duration (Months)

142.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Surgery	Procedure: Robotic Surgery

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 24, 2023

Anticipated Primary Completion Date :

Aug 24, 2026

Anticipated Study Completion Date :

Aug 24, 2026

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Correlation of Automated Performance Metrics to surgeon experience [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Surgeon inclusion criteria:

Performs robotic surgery for candidate procedures
Performs candidate procedures that are frequently performed by at least three surgeons (to ensure the ability to make adequate comparisons)
Agrees to participate in the study

Patient inclusion criteria:

Aged 18 years or older
Scheduled to undergo a robot-assisted surgical procedure involving the prostate, kidney, bladder, colon, pancreas, gallbladder, stomach, uterus, or lung

Exclusion Criteria:

Patient exclusion criteria:

Scheduled to undergo multiple panel procedures
Scheduled to undergo hybrid procedures involving open and robot-assisted techniques

o Hybrid procedures will involve multiple surgeons from different subspecialties, include certain rare steps, and require the surgeons' improvisation to complete such procedures safely; to avoid data heterogeneity, we have elected to exclude such procedures

Refusal to consent to data capture during the procedure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering Monmouth (Limited protocol activities)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center (All protocol activites)	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau (Limited Protocol Activites)	Rockville Centre	New York	United States	11553