Effect of Video-based Guided Self-reflection on Intraoperative Skills

Laparoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04643314
• Other study ID #: 2020-6348
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: November 2020
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Liane S Feldman, MD
• Phone: 5149341934
• Email: liane.feldman[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Laparoscopy

Intervention

Other:
• Guided video-based self-evaluation
In addition to their usual residency training, participants randomized to this group will undergo the following interventions: The participants will be asked to review their own operating room recordings (of each of the 5 consecutive submitted laparoscopic cholecystectomy cases that the participant acted as the primary operator) and to assess themselves (within 72 hours (3 days) of the procedure) using validated intra-operative assessment tools. The completion of the self-evaluations is to guide and document video-based self-reflection. The duration of self-assessment/reflection session will be up do the participant. Residents in this group will have unlimited access to their recordings through the web-based platform. On the other hand, they will not be able to access the battery of assessment forms after the third day following the procedure.

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Rate of recruitment (acceptability of the trial by trainees)	% of eligible residents who agree to participate in the study	1 year
Primary	Feasibility: Rate of recruitment (acceptability of the trial by attending surgeons)	% of eligible attending surgeons who agree to participate in the study	1 year
Primary	Feasibility: Adherence to intervention	% of adherence with intervention (surgeons: intra-operative assessments; trainees: video-based assessments)	1 year
Primary	Feasibility: Rate of missing assessment data	% of missing responses	1 year
Secondary	Intraoperative performance- In-person: attending surgeon	Intra-operative performance will be assessed by the attending surgeon (present at time of the operation) after each operation (within 72 hours) using the following four tools: The Global Operative Assessment of Laparoscopic Skills (GOALS) Score 5-25 with higher score signifying better skills Operative Performance Rating System (OPRS) Score 10-50 with higher score signifying better skills Eubanks checklist 0-100% with higher score signifying better skills The O-SCORE Entrustability Scale 1-5 with higher score signifying better skills	1 year
Secondary	Procedural times	Time to the following events: time to critical view of safety after completion of adhesiolysis,; time to detachment of the gallbladder from the liver bed after division of the cystic artery and duct; total procedure time (from insertion of first trocar to extraction of the gallbladder).	1 year
Secondary	Perceived usefulness	all participants will be asked to evaluate the perceived utility of video-based self-reflection at baseline. This will be repeated at the end of the trial for the intervention group. In addition, they will be queried about the ease of executing the intervention (recording, storage and retrieval of their procedures) at the end of trial.	through study completion, an average of 1 year
Secondary	Mindset	Dweck Mindset instrument, DMI	through study completion, an average of 1 year
Secondary	Intraoperative performance-Video-based: blinded expert assessor	Intra-operative performance will be assessed by two expert assessors (MIS attending surgeons blinded to the case number or group allocation of the participants) using the following three tools: The Global Operative Assessment of Laparoscopic Skills (GOALS) Score 5-25 with higher score signifying better skills Operative Performance Rating System (OPRS) Score 10-50 with higher score signifying better skills Eubanks checklist 0-100% with higher score signifying better skills	1 year