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临床试验/NCT02138487
NCT02138487已完成不适用

Restricted Convalescence: Outcomes Following Urogynecologic Procedures

Northwestern University6 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2014年8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
105
试验地点
6
主要终点
Satisfaction

研究概览

简要总结

The investigators are conducting a study to better understand the relationship between activity restrictions and women's satisfaction following urogynecologic surgery for prolapse. We hypothesize that women with less stringent postoperative restrictions will have higher levels of satisfaction 12 weeks following surgery with no difference in respect to anatomic outcome.

详细描述

Pelvic floor disorders (PFD) dramatically affect millions of women's quality of life (QOL), and 30% of American women will undergo reconstructive surgery for urinary incontinence or pelvic organ prolapse to improve bothersome symptoms and quality of life. Surgical goals of women with PFD is often to resume their normal activities, which they have limited secondary to bothersome symptoms. Yet, traditionally surgeons placed strict postoperative restrictions on patient's activity levels for 3 months; sometimes even recommending life long lifting and activity restrictions. Activity restrictions are imposed on the premise that exercise can "weaken" surgical healing; however, emerging data from other fields suggests that increased activity may actually promote the healing process. We aim to determine whether satisfaction, recovery, and anatomic outcomes after surgery are related to type of postoperative activity recommendations (liberal versus restricted). Women having surgery for PFD will be randomized to receive either liberal or restricted postoperative activity recommendations and satisfaction, symptoms, QOL and anatomic outcomes will be measured after surgery. We hypothesize that women with liberal activity recommendations will recover more quickly and report higher satisfaction and QOL, have fewer symptoms, and have similar anatomic outcomes to women with restricted activity restrictions. These data will change paradigms of women's health and recovery after surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • Ambulatory women undergoing surgical management of pelvic organ prolapse
  • Prolapse > to Stage II on POP-Q
  • Age >18 yrs
  • Completed childbearing
  • All subjects must have given signed, informed consent prior to registration on study
  • All subjects must be able to read and complete study documents

排除标准

  • Wheelchair-bound women
  • Women with neurologic disease (Multiple Sclerosis, Parkinson's Disease)
  • Abdominal approach with laparotomy

结局指标

主要结局

Satisfaction

时间窗: 12 weeks following surgery

Satisfaction will be assessed following reconstructive pelvic surgery for prolapse using a question which assesses a patient's global impression. Specifically, patients will be asked the question "how satisfied are you with your prolapse surgery?" at 12 wks to assess overall satisfaction. Possible responses include "completely satisfied," "mostly satisfied," "neutral," "mostly dissatisfied," and "completely dissatisfied."

次要结局

  • Anatomic Outcomes(12 weeks and 1 year following surgery)
  • Pain(12 weeks and 1 year following surgery)
  • Activity level(12 weeks and 1 year)
  • Quality of Life(12 weeks and 1 year following surgery)

研究者

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

Kimberly Kenton

Professor of Obstetrics and Gynecology, Professor of Urology, Division Chief Female Pelvic Medicine and Reconstructive Surgery

Northwestern University

研究点 (6)

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