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Restricted Convalescence: Outcomes Following Urogynecologic Procedures (ReCOUP)

2020年6月2日 更新者:Kimberly Kenton、Northwestern University
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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

105

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Illinois
      • Chicago、Illinois、美国、60637
        • University of Chicago
      • Chicago、Illinois、美国、60611
        • Northwestern University, Feinberg School of Medicine
    • Virginia
      • Roanoke、Virginia、美国、24016
        • Virginia Tech Carilion School of Medicine

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Restricted postoperative activity
Women in the "restricted postoperative activity" group must abstain from exercise and heavy lifting for 3 months postoperatively
Women in this group will be given instructions regarding postoperative activity and will need to abstain from heavy lifting, running, aerobics for 3 months.
实验性的:Liberal postoperative activity
Women in the "liberal postoperative activity" group will be allowed to resume their normal activities without restriction.
Women will be given specific instructions regarding postoperative activities and will not have any limitations regarding activity.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Satisfaction
大体时间: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."
12 weeks following surgery

次要结果测量

结果测量
措施说明
大体时间
Anatomic Outcomes
大体时间:12 weeks and 1 year following surgery
Anatomic outcomes will be assessed on physical examination 12 weeks and 1-year following reconstructive pelvic surgery.
12 weeks and 1 year following surgery
Quality of Life
大体时间:12 weeks and 1 year following surgery
Quality of life will be assessed using several validated questionnaires at 12 weeks and 1 year following reconstructive pelvic surgery for prolapse.
12 weeks and 1 year following surgery
Pain
大体时间:12 weeks and 1 year following surgery
Pain will be assessed using a visual analog scale at 12 weeks and 1 year following reconstructive pelvic surgery.
12 weeks and 1 year following surgery
Activity level
大体时间:12 weeks and 1 year
Activity level will be assessed using a validated questionnaire at 12 weeks and 1 year following reconstructive pelvic surgery.
12 weeks and 1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Kimberly Kenton, MD、Northwestern University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年8月1日

初级完成 (实际的)

2020年1月1日

研究完成 (实际的)

2020年1月1日

研究注册日期

首次提交

2014年5月8日

首先提交符合 QC 标准的

2014年5月13日

首次发布 (估计)

2014年5月14日

研究记录更新

最后更新发布 (实际的)

2020年6月4日

上次提交的符合 QC 标准的更新

2020年6月2日

最后验证

2020年6月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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