Clinical trial NCT04643314: Effect of Video-based Guided Self-reflection on Intraoperative Skills
Official title: Effect of Video-based Guided Self-reflection on Intraoperative Skills: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopy
Keywords: laparoscopic surgical skills
self-reflection
operative recording
laparoscopic cholecystectomy
surgical education
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a parallel, two-groups, assessor-blind, single-center, pilot randomized controlled trial.
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Feasibility: Rate of recruitment (acceptability of the trial by trainees)
timeFrame: 1 year
measure: Feasibility: Rate of recruitment (acceptability of the trial by attending surgeons)
timeFrame: 1 year
measure: Feasibility: Adherence to intervention
timeFrame: 1 year
measure: Feasibility: Rate of missing assessment data
timeFrame: 1 year
Secondary outcomes:
measure: Intraoperative performance- In-person: attending surgeon
timeFrame: 1 year
measure: Procedural times
timeFrame: 1 year
measure: Perceived usefulness
timeFrame: through study completion, an average of 1 year
measure: Mindset
timeFrame: through study completion, an average of 1 year
measure: Intraoperative performance-Video-based: blinded expert assessor
timeFrame: 1 year
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University
name: Liane S Feldman, MD
role: PRINCIPAL_INVESTIGATOR
References: