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Clinical Trials/NCT04575987
NCT04575987
Unknown
Not Applicable

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

Poitiers University Hospital1 site in 1 country709 target enrollmentDecember 14, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bariatric Surgery Candidate
Sponsor
Poitiers University Hospital
Enrollment
709
Locations
1
Primary Endpoint
Prevalence of the main PFD
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 14, 2020
End Date
June 14, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Prevalence of the main PFD

Time Frame: 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.

Study Sites (1)

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