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临床试验/NCT03617354
NCT03617354已完成不适用

A Stepped Wedge Cluster Trial to Implement and Evaluate a Model for Training Practising Gynaecologists in Total Laparoscopic Hysterectomy

Queensland Centre for Gynaecological Cancer4 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年3月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
4
主要终点
Change in proportion of hysterectomy

研究概览

简要总结

Removal of the uterus (hysterectomy) is the most commonly performed major gynaecological procedure in women. Obstetricians and gynaecologist (O&G) surgeons conduct the majority of hysterectomies. Surgical approaches to removal of the uterus include laparoscopic hysterectomy, vaginal hysterectomy with or without laparoscopic assistance and open hysterectomy through an abdominal incision. It is widely accepted that laparoscopic hysterectomy and vaginal hysterectomy are less invasive procedures, cause fewer surgical complications, less postoperative pain, require a shorter hospital stay and are associated with quicker recovery than abdominal hysterectomy. In Australia and despite the evidence, Total Abdominal Hysterectomy (TAH) rates are unreasonably high (~40%) and only 13% of all hysterectomies are done via Total Laparoscopic Hysterectomy (TLH) in Australia.

This study aims to implement and evaluate a training program in TLH for gynaecologists. The potential benefits to the community are:

  • A reduction in the incidence of overall surgical adverse events in patients receiving a hysterectomy
  • A reduction in the length of hospital stay for patients requiring a hysterectomy
  • A reduction in the direct hospital costs for hysterectomy

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in proportion of hysterectomy

时间窗: 36 months

proportion of hysterectomies performed abdominally through TAH comparing pre-intervention baseline and post-intervention rates

次要结局

  • Cost effectiveness(36 months)
  • Adverse Events(36 months)
  • Length of hospital stays(36 months)
  • Trainee Surgeon proficiency with Total Laparoscopic Hysterectomy(36 months)

研究者

发起方
Queensland Centre for Gynaecological Cancer
申办方类型
Other Gov
责任方
Sponsor

研究点 (4)

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