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Clinical Trials/NCT04643314
NCT04643314
Unknown
Not Applicable

Effect of Video-based Guided Self-reflection on Intraoperative Skills: a Pilot Randomized Controlled Trial

McGill University Health Centre/Research Institute of the McGill University Health Centre1 site in 1 country34 target enrollmentAugust 1, 2020
ConditionsLaparoscopy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Laparoscopy
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Enrollment
34
Locations
1
Primary Endpoint
Feasibility: Adherence to intervention
Last Updated
5 years ago

Overview

Brief Summary

While video-assisted structured feedback by expert surgeons significantly improves laparoscopic skill acquisition in surgical trainees, this method is resource intensive and may have limited feasibility outside of research settings. Self-assessment and reflection are integral parts of medical experiential learning; however the value of video-based self-reflection in enhancing surgical skill acquisition remains to be determined.

The objective of the proposed pilot study is to investigate the feasibility of conducting a full-scale randomized controlled trial (RCT) aimed to evaluate the effectiveness of coached video-based self-reflection approach on surgical trainee performance of laparoscopic cholecystectomy.

Detailed Description

The study will be a parallel, two-groups, assessor-blind, single-center, pilot randomized controlled trial with participants (surgical trainees) individually allocated on a 1:1 ratio to intervention group (guided video-based self-evaluation in addition to traditional intraoperative teaching by faculty surgeons) and a control group (traditional intraoperative teaching alone). All the trainees participating in this trial will be asked to submit intra-operative video-recordings of 5 consecutive laparoscopic cholecystectomies performed by them as the primary operator. In this trial the intervention group participants will be asked to perform a guided self-assessment of their intra-operative skills by watching their operative video-recording. The trainee's self-assessment will be guided by validated intra-operative performance assessment tools. The control group will not have access to their recorded video submissions during the duration of this study. Outcomes assessed will include trainee's intra-operative performance and time to completion of surgical procedure, Information generated from the pilot study will help inform a full-scale RCT by testing the study procedures. Feasibility outcomes will include number of trainees and surgeons approached, consented and randomized and adherence with intervention(surgeons: intra-operative assessments; trainees: video-based assessments). Data from this pilot study will inform the calculation of sample size requirements for the full-scale RCT.

Registry
clinicaltrials.gov
Start Date
August 1, 2020
End Date
July 30, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible Party
Principal Investigator
Principal Investigator

Dr. Liane S. Feldman

Professor of Surgery and Chief of the Division of General Surgery at McGill University

McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria

Inclusion Criteria

  • All residents involved at the McGill General Surgery Program (total of 35 residents on clinical rotations)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Feasibility: Adherence to intervention

Time Frame: 1 year

% of adherence with intervention (surgeons: intra-operative assessments; trainees: video-based assessments)

Feasibility: Rate of missing assessment data

Time Frame: 1 year

% of missing responses

Feasibility: Rate of recruitment (acceptability of the trial by trainees)

Time Frame: 1 year

% of eligible residents who agree to participate in the study

Feasibility: Rate of recruitment (acceptability of the trial by attending surgeons)

Time Frame: 1 year

% of eligible attending surgeons who agree to participate in the study

Secondary Outcomes

  • Procedural times(1 year)
  • Perceived usefulness(through study completion, an average of 1 year)
  • Intraoperative performance- In-person: attending surgeon(1 year)
  • Mindset(through study completion, an average of 1 year)
  • Intraoperative performance-Video-based: blinded expert assessor(1 year)

Study Sites (1)

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