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临床试验/NCT01618292
NCT01618292已完成不适用

Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy

Atlantic Health System1 个研究点 分布在 1 个国家目标入组 393 人开始时间: 2007年1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
393
试验地点
1
主要终点
Changes in bowel function

研究概览

简要总结

Compare changes in bowel function before, 6 months and one year after Robotic-assisted laparoscopic sacral colpopexy. Compare objective anatomic outcomes before, 6 months and one year after Robotic-assisted laparoscopic sacral colpopexy.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • All patients who underwent robotic assisted laparoscopic sacral colpopexy

排除标准

  • Any other procedure for the treatment of pelvic organ prolapse

结局指标

主要结局

Changes in bowel function

时间窗: preoperatively, 6 months, and one year post-surgery

-Patients completed a validated colo-rectal-anal distress inventory (CARDI-8) at all 3 intervals. Specific complaints of splinting with defecation, excessive straining/pain with bowel movements, incomplete bowel emptying/obstructive symptoms and fecal incontinence were addressed. In addition, patients completed a validated colorectal-anal impact questionnaire (CRAIQ-7) at all 3 intervals. The CRAIQ-7 addresses bowel symptoms and the extend of quality of life impingement

次要结局

  • Objective anatomic outcomes(preoperatively, 6 months, and one year after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Pagnillo

Patrick Culligan, MD

Atlantic Health System

研究点 (1)

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