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临床试验/NCT00555243
NCT00555243已完成不适用

An Evaluation of Validated Laparoscopic Skills Simulators and the Impact on Operating Room Performance

University of Texas Southwestern Medical Center8 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2005年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
8
主要终点
Whether laparoscopic simulators truly affect real time performance in the operating room among Gynecology residents

研究概览

简要总结

The primary goal of this study is to answer whether validated laparoscopic simulators truly affect real time performance in the operating room among Gynecology residents.

详细描述

We have designed a randomized control trial to assess the impact of a laparoscopic simulator curriculum on operating room performance amongst gynecology residents. At the beginning of the study, each resident that chooses to participate will take a multiple choice pre-test assessing his or her background knowledge of laparoscopic surgical principles. Everyone will then listen to a series of lectures / video demonstrations teaching the fundamentals of laparoscopic surgery. The final part of the orientation is to have each resident perform 5 tasks on the laparoscopic simulators (peg transfer, endoloop, pattern cutting, intracorporeal suturing, and extracorporeal suturing) while being proctored by a faculty member who is timing the task and recording any errors made. Each resident will have 2 proctored performances (pre- and post) on the simulator and it will be set up as a typical OSCE-type exam. We chose to have them perform 2 repetitions as opposed to the usual 1 (like on the MCAT, SAT, or other high stake exam) to allow for potential unfamiliarity with the simulator equipment.

The residents will then perform a laparoscopic tubal ligation with a faculty member when they begin their Benign Gynecology rotation. Each resident will subsequently be randomized either traditional teaching (no simulator) or five 30-minute faculty-directed sessions at the Laparoscopic Simulator Lab. Those randomized to simulation training can practice and perform as many repetitions necessary on the simulator to achieve proficiency. Prior to completing the rotation, the residents will perform another laparoscopic tubal ligation with a faculty member blinded to whether they randomized to simulator training to re-assess their technical skills. The resident will have another proctored examination of simulator performance on the five tasks. Finally, a videotape review by independent observers will verify precision of the surgical evaluations at the conclusion of the study.

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

  • All Ob/Gyn residents in post-graduate years 1-4 from ACGME accredited programs

排除标准

  • 未提供

研究组 & 干预措施

1

Experimental

Laparoscopic Simulation Education

干预措施: Laparoscopic Simulation training (Procedure)

2

Placebo Comparator

干预措施: Traditional Surgical Education (Procedure)

结局指标

主要结局

Whether laparoscopic simulators truly affect real time performance in the operating room among Gynecology residents

时间窗: Over the course of one resident rotation (4-6 weeks)

次要结局

  • Determine if the level of improvement is inversely related to resident level of training.(Over the course of one resident rotation (4-6 weeks))
  • Establish whether psychomotor testing predicts surgical proficiency and helps identify those who may need more intensive training over the course of their education.(Over the course of one resident rotation (4-6 weeks))
  • Calculate receiver operator curves to aid in the establishment of a "passing score" threshold on the validated laparoscopic simulators(Over the course of one resident rotation (4-6 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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