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临床试验/NCT04575987
NCT04575987Unknown不适用

How Bariatric Surgery Impacts Pelvic Floor Disorders Evolution : Analysis on a Cohort From a French Hospital.

Poitiers University Hospital1 个研究点 分布在 1 个国家目标入组 709 人开始时间: 2020年12月14日最近更新:
适应症

试验速览

阶段
不适用
入组人数
709
试验地点
1
主要终点
Prevalence of the main PFD

研究概览

简要总结

Bariatric surgery is increasingly practiced, as it is the most efficient treatment for morbid obesity. More than eighty percent of the operated patients are women. Nethertheless, few is known about gynecologic long-term impact of such surgeries, especially regarding pelvic floor disorders (PFD). This work aims at studying the evolution of PFD in women following a bariatric surgery more than 18 months ago in a French university center Hospital.

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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • aged from 18 to 50 years old the day of their surgery,
  • had a bariatric surgery in Poitiers university hospital center (France),
  • are under french social security system.

排除标准

  • to be under guardianship or tutelage measures
  • to express opposition to participate to this study.

结局指标

主要结局

Prevalence of the main PFD

时间窗: minimum 18 months after surgery

To evaluate the prevalence of the main PFD regarding the efficiency of the bariatric surgery 18 months or more after. The prevalence of PFD will be estimated thanks to the PFDI-20 questionnaire : * urinary incontinence : at least one positive answer to questions 16 to 18 of PFDI-20 * bowel incontinence : at least one positive answer to questions 8 to 10 of PFDI-20 * vaginal prolapse : positive answer to question 3 of PFDI-20 Efficiency of the bariatric surgery will be estimated thanks to the weight registered in the medical file before bariatric surgery and the most recent weight obtained thanks to the questionnaire. Our results will be adjusted for age, menopausal status, obstetrical and surgical history.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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