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。

Assessing Effectiveness of Laparoscopic Colorectal Surgical Skills

2014年12月12日 更新者:Conor Delaney, MD, PhD、University Hospitals Cleveland Medical Center
The purpose of this study is to improve the investigators understanding of different training methods in laparoscopic colon surgery.

研究概览

地位

终止

条件

详细说明

In this study the investigators use an objective evaluation system which deconstructs laparoscopic colectomy into its component steps. Critical components of the procedure as well as overall operative performance can be evaluated. This is applied to surgeons and trainee surgeons attending laparoscopic colorectal training courses using different training models to compare each model and correlate outcomes with each model to pre-course experience. This project is aimed at better educating trainers and getting better information on the validity of new training models for laparoscopic colectomy.

Aims of Project

  • To observe and assess surgical technique during laparoscopic colorectal skills training courses using a previously validated tool for formal assessment of surgical technical skills.
  • To evaluate technical errors and patterns of error during training at laparoscopic colectomy.
  • To determine outcomes and error rates with different training models and correlate these with prior surgical experience.

Number of participants/subjects in research:

Subjects will be recruited in several sites:

  • the principal investigators facility at University Hospitals of Cleveland Case Medical Center, where surgeons from outside institutions visit regularly for training courses
  • Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Laparoscopic colorectal training courses, where surgeons participate in courses with invited faculty at national meetings (the PI is national Program Director and runs these courses).
  • American Society of Colorectal Surgeons (ASCRS) Laparoscopic colorectal training courses, where surgeons participate in courses with invited faculty at national meetings (the PI is national Program Director and runs these courses).

Course attendees will be informed before the start of an appropriate laparoscopic course that the study is being performed. The study will be explained to them in detail and they will be given a copy of the appropriate paperwork to review. Verbal consent will be requested. It will be explained to them that they should feel under no pressure to participate in the study, and that if they do participate that these data are not used for their evaluation. The number of cases of components of cases that they perform will not be related to participation or non-participation in the trial.

Study Design This is an observational study in which trainees' technical surgical skills are evaluated while performing specific steps of laparoscopic colectomy cases, as outlined in the accompanying datasheets. The plan is to enroll 200 participants.

At the completion of each case, forms will be completed by the trainee, and by the teaching / supervising surgeon. Independent observers cannot be used, as only an attending laparoscopic colorectal surgeon is adequately skilled to score the resident performing the case, and it is not feasible to have a second attending surgeon present during each case.

Dr Delaney will score trainees when possible using the standardized form. For courses at University Hospitals Case Medical Center (UHCMC), the colorectal faculty will be instructed in standardized assessment, and will also assess trainees. For courses at SAGES or ASCRS, the course faculty will be shown the training assessments and directed in the standardized assessment prior to evaluations.

研究类型

观察性的

注册 (实际的)

83

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

    • Ohio
      • Cleveland、Ohio、美国、44106
        • University Hospitals Case Medical Center

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

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Surgeons and trainee surgeons attending laparoscopic colorectal training courses.

描述

Inclusion Criteria:

Subjects will be recruited in several sites:

  • The principal investigators facility at University Hospitals of Cleveland Case Medical Center, where surgeons from outside institutions visit regularly for training courses
  • Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Laparoscopic colorectal training courses, where surgeons participate in courses with invited faculty at national meetings (the PI is national Program Director and runs these courses).
  • American Society of Colorectal Surgeons (ASCRS) Laparoscopic colorectal training courses, where surgeons participate in courses with invited faculty at national meetings (the PI is national Program Director and runs these courses).

Exclusion Criteria:

Not applicable

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

  • 观测模型:队列
  • 时间观点:预期

队列和干预

团体/队列
Surgeons
Surgeons and trainee surgeons attending laparoscopic colorectal training courses will be recruited to study using different training models to compare each model and correlate outcomes with each model to pre-course experience. .
Trainee Surgeons
Surgeon and trainee surgeons attending laparoscopic colorectal training courses will be recruited to study using different training models to compare each model and correlate outcomes with each model to pre-course experience.

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
To observe and assess surgical technique used by surgeons and surgeon trainees in attendance during laparoscopic colorectal skills training courses.
大体时间:one year
To observe and assess surgical technique by surgeons and surgeon trainees in attendance during laparoscopic colorectal skills training courses using a previously validated tool for formal assessment of surgical technical skills.
one year

次要结果测量

结果测量
措施说明
大体时间
To evaluate technical errors and patterns of error by surgeons and surgeon trainees during training of laparoscopic colectomy.
大体时间:one year
To evaluate technical errors and patterns of error of surgeons and surgeon trainees during training at laparoscopic colectomy. To determine outcomes and error rates with different training models and correlate these with prior surgical experience
one year

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。

调查人员

  • 首席研究员:Conor P Delaney, MD, PhD、University Hospitals Cleveland Medical Center

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

2009年9月1日

初级完成 (实际的)

2012年6月1日

研究完成 (实际的)

2012年6月1日

研究注册日期

首次提交

2010年4月29日

首先提交符合 QC 标准的

2010年5月6日

首次发布 (估计)

2010年5月7日

研究记录更新

最后更新发布 (估计)

2014年12月15日

上次提交的符合 QC 标准的更新

2014年12月12日

最后验证

2012年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • 07-09-04 (其他标识符:Unversity Hospitals Case Medical Center)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

3
订阅