Motion Capture as a Tool for the Assessment of Laparoscopic Performance

March 21, 2025 updated by: Ottawa Hospital Research Institute
The goal of this study is to 1) identify motion capture variables that can be used to differentiate surgical experience level and 2) evaluate if these variables can be used in a surgical education setting to improve resident performance.

Study Overview

Status

Completed

Conditions

Detailed Description

This will be a two-phase study that will take 2 years to complete.

Phase 1 will recruit staff surgeons, surgical fellows, and residents from the departments of Obstetrics and Gynecology, Urology, General Surgery, and Thoracics at The University of Ottawa and The Ottawa Hospital to complete a set of FLS tasks. Logistic regressions will be used to identify significant factors that differentiate surgical experience level (junior residents, senior residents, fellows, and staff). Classification of residents will depend on their current cohort in the CDB or traditional time-based system: A target interval will be computed for each significant factor based on the staff surgeons' average performance. This target interval will be used to assess resident performance in Phase 2.

Phase 2 will recruit Transition to Discipline residents from each department to complete 3 sets of FLS tasks. Participants will be randomized into an "objective feedback" group or a "no feedback" group. Participants randomized to the objective feedback group will receive a report that compares their performance in Set 1 to that of the staff surgeons' using the target interval as a reference. Participants receiving objective feedback will then complete Sets 2 and 3 knowing what factors to improve upon. Participants receiving no feedback will complete all sets with no intervention. Phase 2 data collection will start once Phase 1 is completed.

Trajectories of retro-reflective markers will be recorded using a 6-camera motion analysis system (40MXF-40 Vicon cameras, Oxford Metrics, Oxford, UK) sampling at 100 Hz with supporting Nexus software (v2, Oxford Metrics, Oxford, UK). Retro-reflective markers will be placed on various anatomical landmarks on the participant's body based on a cluster marker set. Laparoscopic surgical tools (grasper, scissors, or dissector) will have a marker triad fixed to the upper shaft while a laparoscopic trainer (FLS Trainer System, Limbs & Things, Savannah GA) will have markers placed at its corners. Using Vicon Nexus software, raw marker trajectories will be filtered and used to compute local coordinate systems of the upper body, joint centers, and subsequent joint angles while filtered marker trajectories on the laparoscopic tools will compute the tool tip's motion and orientation relative to the box trainer's workspace. Inertial measurement units (IMUs) will also be used to capture motion of the upper body and compare to motion capture outcomes (Secondary Objective). Wireless IMUs will be placed along the long axis of the forearm, upper arm, upper spine and lower spine.

Surface electromyography (EMG) signals of the biceps, triceps, anterior deltoid, upper trapezius, wrist extensors and flexors will also be recorded using a wireless EMG system (Trigno, Delsys Inc., Natick MA) and recorded using Nexus. Sensors will be placed over the muscle bellies following SENIAM guidelines [34] and signals will be sample data 100Hz with a 20-450Hz bandpass. All experimental EMG signals will be appropriately conditioned and normalized to maximum EMG value elicited during maximum voluntary isometric contraction (MVIC) exercises. Three repetitions of each MVIC exercise will be performed before the experimental task and will include elbow flexion and extension, arm abduction, arm flexion, and wrist flexion and extension. A minimum of 30 seconds rest will be given between each exercise to mitigate effects of fatigue.

Motion and EMG data will be exported to a custom MatLab (2019, Mathworks, Natick, MA) application to compute objective measures of laparoscopic performance: instrument tip pathlength, average (±1 stdev) excursion velocity, average (±1 stdev) excursion error, average (±1 stdev) upper body kinematics (shoulder, elbow, wrist, neck and trunk) in all three planes of motion, and integrated EMG.

Video of the surgical tasks will be recorded and synced to marker trajectory data using an external trigger. Videos will be de-identified, and the last repetition assessed by three staff surgeons. First, the raters will categorize each video as Transition to Discipline resident, Foundation of Discipline resident, Core Discipline resident, Transition to Practice resident, fellow, or staff surgeon based other their general perception of the performer's experience level. The raters will then score each video following the FLS scoring system (based on timing and penalty scores), and the OSATS evaluation grid.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

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

    • Ontario
      • Ottawa, Ontario, Canada, K1G 7W9
        • Ottawa Hospital Research Institute

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • staff surgeons, surgical fellows and residents
  • primary affiliation with the departments of Obstetrics and Gynecology, Urology, General Surgery, and Thoracics at the University of Ottawa and The Ottawa Hospital

Exclusion Criteria:

  • current injury/condition that in the opinion or the participant and/or research team will affect performance

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Objective Feedback (Motion Capture)
Participants in the objective feedback group will receive a report that compares their performance in Set 1 to that of the staff surgeons' using the target interval as a reference. Participants receiving objective feedback will then complete Sets 2 and 3 knowing what factors to improve upon.
Participants assigned to the objective feedback group will be given a report after completing Set 1 and Set 2. This report will outline their performance for each significant factor (identified in Phase 1) relative to a target interval, derived from the staff surgeon group average (± one standard deviation). Participants assigned to the objective feedback group will then be able to repeat the tasks knowing which variables to improve.
No Intervention: No Feedback
Participants receiving no feedback will complete all sets with no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion time
Time Frame: 1 year
Time to complete each task measured in seconds
1 year
Instrument pathlength
Time Frame: 1 year
Pathlength of surgical instrument tip measured in cm
1 year
Motion smoothness
Time Frame: 1 year
Motion smoothness of surgical instrument tip measured by the number of changes in acceleration (m/s^2)
1 year
Instrument orientation
Time Frame: 1 year
Orientation of surgical instrument tip measured in the three planes of motion (depth, pitch, roll, yaw), quantified in degrees relative to the surgical trainer box's local coordinate system.
1 year
Fundamentals of Laparoscopy Skill (FLS) score
Time Frame: 1 year
- A numbered score is calculated following procedures outlined in the Fundamentals of Laparoscopy Skills (FLS) modules
1 year
Objective Structured Assessment of Technical Skills (OSATS) score
Time Frame: 1 year
- A numbered score is computed from a global rating system based evaluation grid.
1 year
Participant classification
Time Frame: 1 year
Blinded reviews will classify participants as junior residents, senior residents, fellows/staff based on their perception of participant skill level.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Electromyography
Time Frame: 1 year
  • Muscles: erector spinae, biceps, triceps, anterior deltoid, upper trapezius, wrist extensors, wrist flexors
  • Amplitude quantified as %maximum measured during maximal effort trials
1 year
Muscle activation symmetry
Time Frame: 1 year
  • Muscles: erector spinae, biceps, triceps, anterior deltoid, upper trapezius, wrist extensors, wrist flexors
  • Symmetry indices will be quantified as non-dominant side/dominant side.
1 year
Upper body kinematics
Time Frame: 1 year
- Body orientation will be measured in degrees for the shoulder, elbow, wrist, neck, trunk
1 year

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Sukhbir Singh, Ottawa Hospital Research Institute

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.

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)

May 1, 2021

Primary Completion (Actual)

October 11, 2023

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

November 22, 2020

First Posted (Actual)

November 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 20200631-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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