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临床试验/NCT02716506
NCT02716506进行中(未招募)不适用

Finnish Pelvic Organ Prolapse Surgery Survey 2015: Incidence, Methods, Complications and Effect on Quality of Life of Pelvic Organ Prolapse Operations in Finland in 2015

Society for Gynecological Surgery in Finland1 个研究点 分布在 1 个国家目标入组 3,515 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
3,515
试验地点
1
主要终点
Quality of Life After the POP Surgery

研究概览

简要总结

The aim of this study is to investigate the safety and effectivity of pelvic organ prolapse (POP) surgery. In this multi center study the population consists of POP operations done in Finland year 2015.The study is prospective and validated questionnaires are used to measure the symptoms of POP and the quality of life before and six months after the operation. Methods and complications of surgery are reported by doctors in all 40 participant hospitals.

详细描述

Patients awaiting for surgical procedure for a symptomatic pelvic organ prolapse (POP) are recruited for the study. The recruiting is done in 41 hospitals in Finland, at gynecological outpatient clinics. Participants are given information of the study and give a written approval to join the study. Participants are asked to fill in questionnaires, that measure the quality of life. Three validated questionnaires are used: Pelvic Floor Distress Inventory PFDI-20, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire PISQ-12 and health-related quality of life instrument 15D. These questionnaires are sent to participants 6 months, 2 and 5 years after the surgical treatment. The participants are also asked to report adverse effects related to the treatment and their satisfaction to the treatment. Information about the surgical procedure (i.e. type and duration of the procedure, blood loss, antibiotic and thrombosis prophylaxis) by the operating doctors. Both immediate and delayed treatment-related adverse effects are also reported by the doctors. Data is partly collected by questionnaires filled in internet. All the collected data is protected by high security and coded before analyses. Permission of protocol used in this study is given by the Ethical Committee of University of Eastern Finland and Finnish National Institute for Health and Welfare.

研究设计

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

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Symptomatic pelvic organ prolapse
  • Mental and psychological ability to understand the study information and to give an approval
  • Knowledge of Finnish or Swedish language

排除标准

  • Other than Finnish or Swedish language
  • Psychological disability to understand the study information

结局指标

主要结局

Quality of Life After the POP Surgery

时间窗: 24 months after the surgery

Quality of life is measured by using 15 dimensional quality of health measurement instrument. Minimum value is 0 and maximum value is 1. Higher scores mean better outcome.

次要结局

  • Symptoms Related to Pelvic Organ Prolapse(24 months after the surgery)

研究者

发起方
Society for Gynecological Surgery in Finland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nina Mattsson

MD

Society for Gynecological Surgery in Finland

研究点 (1)

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