跳至主要内容
临床试验/NCT06147128
NCT06147128Enrolling By Invitation不适用

Proficiency Based Progression Training Versus Traditional Training During a Robotic Emergency Conversion Due to a Vessel Injury in a Simulated Setting: a Prospective, Randomized, Multicenter Clinical Trial: The T-REC Trial

Orsi Academy1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2023年8月10日最近更新:
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试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
Orsi Academy
入组人数
48
试验地点
1
主要终点
Comparison between PBP training versus traditional training for an emergency scenario where an open conversion is necessary due to a (simulated) vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system.

研究概览

简要总结

This randomized controlled trial aims to compare the effectiveness of traditional training approach to training with the proficiency-based progression (PBP) approach for teaching the technical skills (TS) and non-technical skills (NTS) for surgeons in the context of an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery.

详细描述

In a prospective, randomized and blinded study surgical residents (n = 48) from Belgium university (i.e. the Katholieke Universiteit [KU] Leuven and University of Gent residency training programs) will be enrolled and randomized to Traditional type training proficiency-based progression (PBP) training to learn how to perform an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model. Specifically, this study will include four independent arms, each employing different training methodologies for technical skills (TS) and non-technical skills (NTS).

Group 1 will receive standard training for both TS and NTS. Group 2 will receive PBP training for TS and standard training for NTS. Group 3 will receive standard training for TS and PBP training for NTS. Group 4 will receive PBP training for both TS and NTS.

All four group will receive the same e-learning on TS and NTS (on an emergency scenario where (simulated) open conversion is necessary due to vessel injury during robotic surgery on a dry lab model). The PBP trained group will however be required to demonstrate quantitively defined proficiency benchmarks for training progression (i.e., for the e-learning, TS and NTS). The Traditional trained group will train in the same laboratory for a case-matched period of time as the PBP group, with the same level of supervising faculty proctors and using the same training resources but with no proficiency benchmarks.

Investigators will be trained in pairs to assess performance from a pre-defined set of explicitly defined binary metric events reliably (inter-rater reliability > 0.8). They will also be blinded as to the identity of the trainee performing the procedure, how they were trained (i.e., group) and procedure order.

H1 It is hypothesized that implementation of PBP training in teaching TS and NTS for surgeons in the context of an emergency scenario where (simulated) open conversion is necessary due to vessel injury during robotic surgery, leads to better surgical training outcomes (i.e., lower number of performance errors) when compared to traditional training.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • recently accepted, form first to last year residents' gynecology and obstetrics, urology and general surgery.
  • Ability to perform a laparotomy

排除标准

  • Any robotic experience with emergency undocking.

结局指标

主要结局

Comparison between PBP training versus traditional training for an emergency scenario where an open conversion is necessary due to a (simulated) vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system.

时间窗: 1 year

Proficiency level will be determined by objectively assessed, validated, binary performance operative metrics where the proficiency benchmark is defined on the mean of the objectively assessed performance of experienced practitioners. The aim of this study is to report the main performance outcomes of the T-REC trial. The investigators will compare differences between four groups in performance level as assessed by binary performance metrics of an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system. The four groups deffers for the training methodology used (PBP vs traditional training). The dependant variables will be the i) time required to complete the procedure, ii) the number of procedure steps completed, iii) the number of errors made, iv) the number of critical errors made and whether the procedure was completed or not.

次要结局

  • Trainee's satisfaction as assessed by questionnaire. Does it influence outcome of surgical training? Comparison between PBP training versus traditional training group.(2 years)
  • Correlation between live and video-based scoring of surgical performance(2 years)
  • Reporting the outcome of the e-learning scores from an online proficiency questionnaire on an online learning platform.(2 years)

研究者

发起方
Orsi Academy
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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