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临床试验/NCT03360357
NCT03360357撤回不适用

Laparoscopic Vaginal Cuff Suturing Proficiency Following Two Standard Educational Approaches: A Randomized Controlled Trial

Mayo Clinic0 个研究点开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
Mayo Clinic
主要终点
Proficiency of laparoscopic suturing of OBGYN residents

研究概览

简要总结

A recent survey of obstetrics and gynecology fellowship program directors showed that graduating OB/GYN residents may be underprepared for advanced laparoscopic training, necessitating an evaluation of the current structure of resident and fellow curriculum. Specifically, only 46% of first year fellows were able to independently perform an abdominal hysterectomy. Out of 28 residents tested using a previously validated laparoscopic cuff suturing model, only 8 (28.6%) passed the assessment.

For this reason, it is necessary to identify the most effective and efficient educational approaches to obtain procedural proficiency. Time and effort has been placed in developing simulation programs. Simulation has shown promising outcomes in improving the performance of trainees and attending physicians with the ultimate objective of generating better surgeons. A previous meta-analysis of simulation-based educational assessments demonstrated that these assessments correlate positively with patient-related outcomes. However, there are limited studies with adequate validity to use simulation for summative evaluations of performance for gynecology residents. The widely used Fundamentals of Laparoscopic Surgery (FLS) program is used for credentialing of general surgeons, however, a systematic review suggested that more validity evidence is required to support its content (selection of tasks and scoring rubric) and the consequences (favorable and unfavorable impact) assessment. Although there has been an increase in the number of models available to teach OB/GYN common gynecologic procedures, there is a lack of evidence to support that these methods are actually allowing residents to create better surgical skills.

To address the current limitations in OB/GYN training, the investigators have developed short, guided drills that cover the steps required for laparoscopic suturing and allow residents opportunities for deliberate practice. These drills will be tested compared to residents watching a laparoscopic suturing video and practicing using a high fidelity, suturing simulation model. Both of these methods are standard educational approaches for teaching laparoscopic skills, but it is unknown if one of the approaches is more effective than the other.

详细描述

Methods: Describe, in detail, the research activities that will be conducted under this protocol:

This study is a randomized controlled trial comparing laparoscopic suturing skills, specifically vaginal cuff closure, of OBGYN residents, fellows, and faculty using two different teaching methods and evaluate if there is any significant difference in their performance after teaching with the two different educational approaches. The laparoscopic camera/scope within a box trainer will video record the drills and the cuff suturing evaluation anonymously. These anonymous videos will be used to set proficiency standards for the drills and evaluate which educational approach is most effective.

The educational video and high fidelity simulation practice group will watch a 10 minute educational video on how to suture laparoscopically and then practice using a high fidelity simulation model for 15 minutes.

The second group is going to consist of "guided drills" as their laparoscopic training for 15 minutes. The residents will perform 5 set of exercises:

  1. "Needle Dance" (Learning to manipulate the suture)
  2. "Loopy Loop" (Learning to place needle through a loop)
  3. "Slalom Course" (Passing the needle and suture through 5 rings right handed and left handed)
  4. "Dense Matter" (Passing the needle through dense material without losing control of the needle)
  5. "Respect for tissue" (Passing the needle through flimsy material without tearing)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current OBGYN residents, fellows, and faculty at ACGME accredited residencies in the United States

排除标准

  • - Non-current OBGYN residents at at ACGME accredited residencies in the United States

结局指标

主要结局

Proficiency of laparoscopic suturing of OBGYN residents

时间窗: 15 minutes

Vaginal cuff suturing proficiency will be higher in OB/GYN residents assigned to guided laparoscopic drills compared to residents assigned to an education video and high fidelity vaginal cuff suturing simulation model.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher C. Destephano

Principal Investigator

Mayo Clinic

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