NCT04646304

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable healthy

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

First Submitted

Initial submission to the registry

November 3, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 27, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

2.4 years

First QC Date

November 3, 2020

Last Update Submit

March 21, 2025

Conditions

Keywords

surgical traineessurgical staff

Outcome Measures

Primary Outcomes (7)

  • Completion time

    Time to complete each task measured in seconds

    1 year

  • Instrument pathlength

    Pathlength of surgical instrument tip measured in cm

    1 year

  • Motion smoothness

    Motion smoothness of surgical instrument tip measured by the number of changes in acceleration (m/s\^2)

    1 year

  • Instrument orientation

    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

    \- 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

    \- A numbered score is computed from a global rating system based evaluation grid.

    1 year

  • Participant classification

    Blinded reviews will classify participants as junior residents, senior residents, fellows/staff based on their perception of participant skill level.

    1 year

Secondary Outcomes (3)

  • Muscle Electromyography

    1 year

  • Muscle activation symmetry

    1 year

  • Upper body kinematics

    1 year

Study Arms (2)

Objective Feedback (Motion Capture)

OTHER

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.

Other: Objective Feedback (Motion Capture)

No Feedback

NO INTERVENTION

Participants receiving no feedback will complete all sets with no intervention.

Interventions

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.

Objective Feedback (Motion Capture)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1G 7W9, Canada

Location

Related Publications (6)

  • Sanchez A, Rodriguez O, Sanchez R, Benitez G, Pena R, Salamo O, Baez V. Laparoscopic surgery skills evaluation: analysis based on accelerometers. JSLS. 2014 Oct-Dec;18(4):e2014.00234. doi: 10.4293/JSLS.2014.00234.

    PMID: 25489218BACKGROUND
  • Moorthy, Munz, Dosis, Bello, Darzi. Motion analysis in the training and assessment of minimally invasive surgery. Minim Invasive Ther Allied Technol. 2003 Jul;12(3):137-42. doi: 10.1080/13645700310011233.

    PMID: 16754092BACKGROUND
  • Farcas MA, Trudeau MO, Nasr A, Gerstle JT, Carrillo B, Azzie G. Analysis of motion in laparoscopy: the deconstruction of an intra-corporeal suturing task. Surg Endosc. 2017 Aug;31(8):3130-3139. doi: 10.1007/s00464-016-5337-4. Epub 2016 Dec 7.

    PMID: 27928669BACKGROUND
  • Gray RJ, Kahol K, Islam G, Smith M, Chapital A, Ferrara J. High-fidelity, low-cost, automated method to assess laparoscopic skills objectively. J Surg Educ. 2012 May-Jun;69(3):335-9. doi: 10.1016/j.jsurg.2011.10.014.

    PMID: 22483134BACKGROUND
  • Ganni S, Botden SMBI, Chmarra M, Li M, Goossens RHM, Jakimowicz JJ. Validation of Motion Tracking Software for Evaluation of Surgical Performance in Laparoscopic Cholecystectomy. J Med Syst. 2020 Jan 24;44(3):56. doi: 10.1007/s10916-020-1525-9.

    PMID: 31980955BACKGROUND
  • Gallagher AG, McClure N, McGuigan J, Ritchie K, Sheehy NP. An ergonomic analysis of the fulcrum effect in the acquisition of endoscopic skills. Endoscopy. 1998 Sep;30(7):617-20. doi: 10.1055/s-2007-1001366.

    PMID: 9826140BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Motion Capture

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Tests, RoutineDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Sukhbir Singh

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: Phase 1 will recruit 4 groups of participants that vary in surgical experience (junior residents, senior residents, surgical fellows, and staff surgeons). Significant differences in objective measures of surgical performance will be identified. A target interval will be computed for each significant factor based on the staff surgeons' average performance. Phase 2 will recruit junior residents to complete the same sets of surgical tasks. Half of the participants will receive objective feedback comparing their performance in Set 1 to the staff surgeons' target interval while the other half will receive no feedback. Differences in performance between Sets 1 and 3 will be quantified and compared between groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 27, 2020

Study Start

May 1, 2021

Primary Completion

October 11, 2023

Study Completion

December 31, 2024

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations