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临床试验/NCT01055860
NCT01055860已完成不适用

One Year Outcome After Robotic Assisted Laparoscopic Sacral Colpopexy, a Case Series Review

Atlantic Health System1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2009年2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
75
试验地点
1
主要终点
1. Objective anatomic outcomes We will use the pelvic organ prolapse quantification system (POP-Q). Objective surgical failure will be defined as any prolapse at or beyond the introitus

研究概览

简要总结

Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce in regard to its long-term outcomes. This advanced procedure is offered at MMH through the Urogynecology division. The Investigators setup to review the one year outcome of patients who underwent this procedure using a polypropylene mesh. These outcomes will include anatomical and quality of life measures.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • Any Robotic assisted laparoscopic sacral colpopexy with polypropylene mesh during the study period

排除标准

  • Other graft material than polypropylene.
  • Enrollment in a different study.

结局指标

主要结局

1. Objective anatomic outcomes We will use the pelvic organ prolapse quantification system (POP-Q). Objective surgical failure will be defined as any prolapse at or beyond the introitus

时间窗: one year

次要结局

  • 2. Prolapse Specific Quality of Life Patients will complete a prolapse specific quality of life instrument prior to and one year after surgery. (PFIQ-7)(one year)
  • 3. Pelvic organ prolapse related symptoms (PFDI-20)(one year)
  • 4. Graft-related complications Rates of graft erosion into adjacent organs such as bowel, bladder or vagina - during the study period will be reported.(one year)

研究者

申办方类型
Other

研究点 (1)

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