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临床试验/NCT01611285
NCT01611285已完成不适用

Uphold Versus Robotic Surgery for Pelvic Prolapse Repair: A Decision Analytic Approach

Atlantic Health System1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Surgical cure versus failure of prolapse repair

研究概览

简要总结

Within the general objective of investigating optimal medical techniques for pelvic prolapse repair, this study proposes to: (1) test the hypothesis that the UPHOLD procedure is more cost effective than robotic surgery for pelvic prolapse repair (2)using formal decision analysis as the comparative strategy

详细描述

The cumulative incidence of pelvic organ prolapse was approximately 2% in 2001. Given the aging demographics in the U.S., the incidence of prolapse is projected to increase to 30% or more for women aged 60 years and older and become of greater concern to both patients and physicians. The demand for gynecologic services is predicted to increase by more than 45% in the next ten years. Prolapse is related to childbirth, aging, defects in collagen, and smooth muscle structure and strength. Etiology includes intra-abdominal pressure from obesity, with obesity becoming an ever increasing factor in the US.

Treatment Choice of Patients:

Patients choose between pessary, surgery, and expectant management based on: age, prior prolapse surgery, preoperative pelvic pain scores, and pelvic organ prolapse severity. These are difficult decisions for patients.

When it comes to choosing between destinctive interventions with subtle advantages and disadvantages, patients typically want to hear their physician's views of the scientific merits of each procedure. Informed consent becomes extremely difficult when issues of cost-effectiveness are at hand. Thus, the proposed project.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Underwent either UPHOLD procedure or Robotic Surgery for Pelvic Organ prolapse

排除标准

  • Other vaginal procedure to correct prolapse

结局指标

主要结局

Surgical cure versus failure of prolapse repair

时间窗: within 12 months of patients surgery

Incidence of recurrance of pelvic organ prolapse within 12 months of either robotic sacrocolpopexy or the UPHOLD procedure

次要结局

  • Financial costs of outcomes(within 12 months of patients surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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