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临床试验/NCT03379246
NCT03379246已完成不适用

Are we Supporting the Apex During Hysterectomy for Pelvic Organ Prolapse?

TriHealth Inc.1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2017年12月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
236
试验地点
1
主要终点
Proportion of Patients Having Concurrent Apical Suspension Performed

研究概览

简要总结

This is a retrospective chart review using TriHealth Electronic Privacy Identification Center (EPIC) to determine whether gynecologic surgeons at a large community hospital are already meeting the recently recommended best practice of supporting the vaginal apex.

详细描述

The prevalence of pelvic organ prolapse (POP) in the United States is estimated to be between 40-50% with an anticipated increase over the next several decades. Approximately 300,000 women undergo surgeries to repair POP in the United States every year. Following pelvic reconstructive surgery, recurrence rates of symptomatic prolapse range between 6-30%. Our understanding of pelvic anatomy and its support has been significantly improved over recent decades, with many researchers reporting on details and mechanics previously not understood.

In November 2017, the American College of Obstetricians and Gynecologists released a new practice bulletin outlining the current standard of care for the treatment of women with pelvic organ prolapse. In this bulletin, they state that a hysterectomy alone is not adequate treatment for pelvic organ prolapse, and further that any woman having a hysterectomy for pelvic organ prolapse should undergo a concurrent apical suspension procedure as a standard of care.

The purpose of this study is to determine the proportion of patients already meeting the recently recommended best practice of supporting the vaginal apex at the time of hysterectomy for pelvic organ prolapse among the population who underwent the surgery performed at a TriHealth facility between October 2012 and October 2017.

研究设计

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

入排标准

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

入选标准

  • Adults 18 years of age or older
  • Underwent hysterectomy for pelvic organ prolapse, performed at a TriHealth facility between October 2012 and October 2017

排除标准

  • Age < 18 years old
  • Pelvic Organ Prolapse was not an indication for their surgery
  • Surgery performed by a physician of Cincinnati Urogynecology Associates.

结局指标

主要结局

Proportion of Patients Having Concurrent Apical Suspension Performed

时间窗: at time of hysterectomy for pelvic organ prolapse

proportion of patients who had concurrent apical support procedures performed

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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