跳至主要内容
临床试验/NCT04643314
NCT04643314Unknown不适用

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 Centre2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
34
试验地点
2
主要终点
Feasibility: Adherence to intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

Due to the nature of the intervention, the participants (resident trainees) cannot be blinded, however the assessors (attending surgeons) who will rate performance will be unaware of group allocation. Any inadvertent unblinding will be reported.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

Feasibility: Adherence to intervention

时间窗: 1 year

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

Feasibility: Rate of missing assessment data

时间窗: 1 year

% of missing responses

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

时间窗: 1 year

% of eligible residents who agree to participate in the study

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

时间窗: 1 year

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

次要结局

  • 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)

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

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

研究点 (2)

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