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临床试验/NCT01916343
NCT01916343
已完成
不适用

Design of a Comprehensive Evidence-Based Laparoscopy Curriculum for Gynecology Residents

Unity Health Toronto1 个研究点 分布在 1 个国家目标入组 27 人2013年7月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Hysterectomy for Abnormal Uterine Bleeding
发起方
Unity Health Toronto
入组人数
27
试验地点
1
主要终点
Technical Performance Score
状态
已完成
最后更新
7年前

概览

简要总结

Gynecologists are currently using laparoscopy to perform many surgeries traditionally approached by laparotomy. The technical skills required for laparoscopic surgery are different than the skills required for laparotomy, causing a prolonged learning curve. Currently there is no standardized laparoscopy curriculum for gynecology residents. This study aims to develop a specific evidence-based surgical skills gynecologic curriculum that could be instituted in residency programs at a national and international level. The investigators will then validate the curriculum using Obstetrics and Gynecology residents through a cognitive examination, a technical skills examination, and a video recording of performance in the operating room.

HYPOTHESIS: The investigators aim is to design a standardized evidence-based comprehensive laparoscopic curriculum that focuses on cognitive knowledge, surgical skills, and team training exercises. The investigators hypothesize that residents in the experimental curriculum-trained group will perform better than the residents in the traditional residency curriculum-trained group on a cognitive examination, a technical skills examination, and in the operating room. The operating room performance will be judged by blinded experts on a previously validated evaluation tool.

注册库
clinicaltrials.gov
开始日期
2013年7月
结束日期
2013年12月
最后更新
7年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Novice residents (defined as having performed less than 10 laparoscopic salpingectomies)
  • Patients undergoing uncomplicated right-sided salpingectomies prophylactically at the time of laparoscopic hysterectomy, laparoscopic salpingo-ophorectomies, or laparoscopic-assisted vaginal hysterectomies.

排除标准

  • Residents who have performed more than 10 laparoscopic salpingectomies
  • Residents in PGY3 or higher
  • Patients with multiple prior abdominal surgeries, high BMI, significant adnexal pathology, and extensive endometriosis

结局指标

主要结局

Technical Performance Score

时间窗: 9 months

Technical performance score will be assessed via a previously validated tool known as the OSA-LS (Objective Structured Assessment of Laparoscopic Salpingectomy), with the score received on the OSA-LS being equivalent to their technical score. The OSA-LS is based on the OSATS9, along with a rating scale that has been modified for laparoscopic cholecystectomy. The latter was developed by the primary investigator, Dr. Teodor Grantcharov, and consists of both a reduced global rating scale (GRS) made suitable for laparoscopic surgery, along with a task-specific rating scale known as the operative component rating scale (OCRS). Previously in a pilot study, ten video recorded operations were assessed in order to standardize assessments and to make adjustments to the overall scale. Residents will be video recorded performing a salpingectomy in the operating room. These recordings will be then be scored as per the OSA-LS, by a blinded observer in order to generate an overall assessment.

次要结局

  • Cognitive Test Scores(5 months)
  • Surgical Skills(5 months)

研究点 (1)

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