此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

Remote Training in Laparoscopy

2021年2月11日更新者：University of Aarhus

Remote Training in Laparoscopy: A Randomized Trial Comparing Home-based Self-regulated Training to Centralized Instructor-regulated Training.

The study is a prospective, randomized comparative study using a mixed methods design. The primary objective is to compare the effect of self-regulated simulation training (SRST) to instructor-regulated simulation training (IRST) in basic laparoscopic skills. The study population is first-year trainees in the specialties General Surgery, Urology and Obstetrics and Gynaecology within the postgraduate training region of northern Denmark. 46 first-year trainees will be randomized into two groups, one receiving SRST and one receiving IRST in basic laparoscopic skills.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

丹麦
- Danmark
  - Aarhus、Danmark、丹麦、8200
    - Centre for Health Sciences Education, Aarhus University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

孩子
成人
年长者

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Participant is a medical doctor
Participant is a first-year trainee in abdominal surgery, urology, or gynaecology and obstetrics.
Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

Performed > 50 lap procedures prior to enrollment
participated in training programs provided by the former course provider in the postgraduate training region of northern Denmark

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：其他
分配：随机化
介入模型：并行分配
屏蔽：单身的

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Self-regulated simulation training	其他：Home-based self-regulated simulation training (SRST) Participants allocated to the SRST arm train basic laparoscopic skills at home. Participants train by themselves using a portable box training model (BT). Training is conducted and structured through an online application-based training platform. Training is instructed by online instructional videos and texts. The BT is connected to a laptop and the participants can submit videos of their training exercises for assessment through the online training platform.
有源比较器：Instructor-regulated simulation training	其他：Centralized instructor-regulated simulation training (IRST) Participants allocated to the IRST arm train basic laparoscopic skills at the simulation centre. Participants train on a portable box training model (BT). Training is structured through an online application-based training platform and facilitated and instructed by surgical specialists. The BT is connected to a laptop and the participants can submit videos of their training exercises for assessment through the online training platform.

参与者组/臂

干预/治疗

实验性的：Self-regulated simulation training

其他：Home-based self-regulated simulation training (SRST)

Participants allocated to the SRST arm train basic laparoscopic skills at home. Participants train by themselves using a portable box training model (BT). Training is conducted and structured through an online application-based training platform. Training is instructed by online instructional videos and texts. The BT is connected to a laptop and the participants can submit videos of their training exercises for assessment through the online training platform.

有源比较器：Instructor-regulated simulation training

其他：Centralized instructor-regulated simulation training (IRST)

Participants allocated to the IRST arm train basic laparoscopic skills at the simulation centre. Participants train on a portable box training model (BT). Training is structured through an online application-based training platform and facilitated and instructed by surgical specialists. The BT is connected to a laptop and the participants can submit videos of their training exercises for assessment through the online training platform.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Mean time for laparoscopic skills test (LASTT). 大体时间：0-7 months	Laparoscopic skills testing models (pre-test, post-test and retention-test). Scoring based on mean timing of 3 consecutively performed exercises (0-180 secs). Low time-scores are better than high time scores.	0-7 months

次要结果测量

结果测量	措施说明	大体时间
Test-score SUTT 大体时间：1-7 months	Laparoscopic knot tying testing model (post-test and retention test). Blinded outcome assessor. Score based on timing and quality of sutures and stitches (score range -2 to 18). High score is better than low score.	1-7 months
Training time 大体时间：6-8 weeks	Accumulated raw training time (mins)	6-8 weeks
Training distribution 大体时间：6-8 weeks	Number of training sessions	6-8 weeks
Pass-rates 大体时间：6-8 weeks	Pass/failure of proficiency-based training program (binary)	6-8 weeks

其他结果措施

结果测量	措施说明	大体时间
Interview 大体时间：0-3 months	Qualitative data: Semi-structured interviews	0-3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Aarhus

合作者

Central Denmark Region

Northern Denmark Region

KARL STORZ Endoscopy Denmark

调查人员

首席研究员：Sigurd B Sloth, MD, PhD fellow、Centre for Health Sciences Education, Aarhus University, Denmark

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年3月1日

初级完成 (实际的)

2020年8月31日

研究完成 (实际的)

2020年8月31日

研究注册日期

首次提交

2020年5月13日

首先提交符合 QC 标准的

2020年5月19日

首次发布 (实际的)

2020年5月26日

研究记录更新

最后更新发布 (实际的)

2021年2月12日

上次提交的符合 QC 标准的更新

2021年2月11日

最后验证

2020年5月1日

Remote Training in Laparoscopy