跳至主要内容
临床试验/NCT02895685
NCT02895685Unknown不适用

The Effect of Group Dynamics in Surgical Skill Training

Copenhagen Academy for Medical Education and Simulation2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016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
80
试验地点
2
主要终点
To examine the effect of off-site self-directed training in groups vs. individual training

研究概览

简要总结

The investigators have planned a randomized study, examining the effect of self-directed training in groups vs. individual training on trainees' acquisitions of open surgical skills.

Eighty participants who signed up for a pre-existing simulation-based course in basic open surgical skills will be randomized to practice either in pairs or individually during the course. Participants open surgical skills will be tested on a simulated skin model before and after the course. The investigators hypothesis is that dyad training will enhance self-directed learning in open surgical skills.

详细描述

The study is a prospective, rater-blinded, randomized, trial, examining the effect of off-site self-directed training in groups versus individual training in open surgical skills.

Setting The study will be conducted at Copenhagen Academy for Medical Education and Simulation, Rigshospitalet, Denmark. The study period will be twelve months from August 2016 to July 2017.

Basic open surgery training programme Copenhagen Academy for Medical Education and Simulation (CAMES) has developed a course in basic surgical skills in open surgery. The course is aimed at junior residents who are about to start a career in surgery. The current course is a six-week course consisting of didactic instructions with an experienced surgeon, expert-guided self-training and self-directed training at home. Each class consists of eight participants. One week before the course starts the participants meet for an introduction. At the introduction participants are provided with training material consisting of a portable knot tying and suturing kit from Ethicon, Surgical Care, Johnson and Johnson and a written material with descriptions of instruments, instructions in different technical skills and theoretical knowledge in open surgery. The following six weeks participants meet once a week for a one and a half hour on-site class in open surgical techniques. The on-site classes are held in a traditional classroom setting at CAMES and consist of didactic instructions followed by expert-guided self-training. The content of each on-site class is predefined. The participants are instructed to read the written material before the on-site classes. The first on-site classes focus on simple open surgical techniques such as knot tying and introduction to instruments and their use. The following on-site classes focuses on suturing techniques. In the end of the course, participants are introduced to more complex tasks in open surgery, such as theory in abdominal opening and closure, dissection and haemostasis (Appendix B). The participants are instructed to practice the technical skills presented in the classroom at home, using the portable knot tying and suture kit. If the participants reach a predefined level of proficiency at the examination test, held within one week after the last on-site class, they are allowed to participate in an operative course in basic open surgery techniques the following week. During the operative course basic concepts of laparotomy, ligation and dissection are practiced. The majority of the operative course focuses on practical training on sedated pigs. Groups of three trainees are supervised by an experienced surgeon.

Participants will be randomized to self-directed training at home in pairs (forty participants) or self-directed training at home individually (forty sixteen participants). All participants will follow the regular course in basic surgical skills in open surgery. Randomization will be en-bloc, so all participants following the same course, with eight participants in each course, will be randomized to follow the same instructions. Participants will be informed that they are expected to take part in classroom on-site classes, but they decide themselves when and how much time to spend practicing and which of the task presented in the classroom they practice.

Technical skill test At the introduction participant's technical skills in open surgery is assessed in a pre-test. The same test is used for examination at the end of the course (post-test). The test is composed of five basic tasks performed on a simulated skin model. The tasks are designed to explore technical skills in three different knot-tying techniques, five different suturing techniques and knowledge in selecting the right instruments and sutures. The examination instructions are presented in written format (Appendix C). Participants are given twenty-five minutes to complete the tasks. Participants are instructed to distribute their time on each task themselves. Unlimited time is given before the test starts to read the instructions carefully and to select the sutures needed. Tests are recorded on video. The camera is placed so only the hands of the trainee and the operation field is showed on the video. Audio will be deleted to allow for blinded rating. To pass the course, the trainees must achieve a predefined proficiency level corresponding to fifty percent (15 points) of the maximum score (30 point) at the post-test. The test will be performed at CAMES assuring optimal height and light setting at every test session.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • The participants may enter the study if any of the following apply:
  • Medical doctor from a department in the Capital Region and the region of Zeeland in Denmark.
  • Medical students employed in internships or research year in surgical departments in the Capital Region and the region of Zeeland in Denmark.
  • The participant is willing and able to give informed consent for participation in the study.

排除标准

  • The participants may not enter the study if any of the following apply:
  • The participant have performed more than 50 open surgical procedures.

结局指标

主要结局

To examine the effect of off-site self-directed training in groups vs. individual training

时间窗: 12 months

Differences between pre-test and post-test scores in basic tasks on a simulated model

次要结局

  • To examine the effect of off-site self-directed training in groups vs. individual training(12 months)

研究者

发起方
Copenhagen Academy for Medical Education and Simulation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Diana Haunstrup Bregner Overgaard

Research Year Student

Copenhagen Academy for Medical Education and Simulation

研究点 (2)

Loading locations...

相似试验

Group Dynamics in Surgical Skill Training | 临床试验