跳至主要内容
临床试验/NCT07533214
NCT07533214Enrolling By Invitation不适用

Impact of Left-Handed Tailored Endoscopic Mitral Simulation Training on Skill Acquisition for Left-handed Surgeons

Academisch Ziekenhuis Maastricht1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
30
试验地点
1
主要终点
Delta time difference of suture placement

研究概览

简要总结

Study Characteristics and Structure are as follows:

All Left-handed cardiac surgeons and residents attending the 2024 EACTS annual meeting (october 2024) are invited to any of the 3-day 8-endoscopic sessions as part of this study trial. The Left-handed cardiac surgeons and residents may participte in any of the sessions which best fits their schedule. Time frame includes all three days of endoscopic simulation sessions as walk-ins according to the availability of each surgeon. The exclusion criteria will be experienced endoscopic left-handed surgeons who are already experts. Left-handed surgeons will be randomized to either the standard right-handed guided simulation training session or to a Left-handed tailored simulation session.

Study Intervention: Left-handed surgeons and residents will be randomized to either a 2-hour Left-handed tailored-guided session (Group 1) or a standard right-handed guided 2-hour endoscopic simulation training session (Group 2).

Setting: EACTS 2024 annual meeting (october 2024 - 3-day convention)

Group 1 will be guided by a left-handed intructor using Left-handed endoscopic suture maps Group 2 will be guided by a right-handed intructor using Standard right-handed suture maps

Pre-course tests will evaluate accuracy and time of endoscopic suture placement in comparison to post-course tests to assess improvements. Pre-session assessments will be carried out evaluating endoscopic suture placement accuracy and time to suture placement. These include:

  1. Time to suture placement under <60 seconds
  2. Accuracy of suture placement considered to be between 2-8 mm
  3. Suture placement locations will be both Anterior and Posterior annular placements

Post-skills sessions assessment: finalizing the 2-hour workshop the participants will be asked to repeat both the anterior and posterior annular endoscopic suture placement.

Final study evaluations and delta time comparisons will be performed to determine if Left-handed surgeons guided by left-handed surgeons outperform or at least fair better then when guided by right-handed instructors.

详细描述

Determine if during endoscopic simulation training the pairing of LH surgeons with LH instructors will outperform LH surgeons guided by right-handed intructors.

Determine whether LH surgeons guided by right-handed instructors on simulation training fair worse against Right-handed to right handed simulation training.

We hypothesize that the pairing of same dexterity tailored training will improve endoscopic skill performance.

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Left handed cardiac surgeons and residents

排除标准

  • experienced endoscopic left handed surgeons

研究组 & 干预措施

Left-handed surgeons with left-handed instructors

Active Comparator

Determine if during endoscopic simulation training the pairing of LH surgeons with LH instructors will outperform LH surgeons guided by right-handed intructors.

干预措施: Endoscopic annular suture placement guided by left handed instructor (Procedure)

Left-handed surgeons with right-handed instructor

No Intervention

Determine whether LH surgeons guided by right-handed instructors on simulation training fair worse against Right-handed to right handed simulation training.

结局指标

主要结局

Delta time difference of suture placement

时间窗: From the randomisation (start of the training) to the end of two-hours training

Final study evaluations and delta time comparisons will be performed to determine if Left-handed surgeons guided by left-handed surgeons outperform or at least fair better then when guided by right-handed instructors. Study Objectives: Determine if during endoscopic simulation training the pairing of LH surgeons with LH instructors will outperform LH surgeons guided by right-handed intructors. Determine whether LH surgeons guided by right-handed instructors on simulation training fair worse against Right-handed to right handed simulation training. We hypothesize that the pairing of same dexterity tailored training will improve endoscopic skill performance.

improvement in seconds taken to perform mitral suturing

时间窗: this will be performed during a two hour course

time duration it takes to successfully place mitral annular sutures on simulators

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peyman Sardari Nia

Cardiothoracic Surgeon

Academisch Ziekenhuis Maastricht

研究点 (1)

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