Long Term Effect of Bariatric Surgery on Pelvic Floor Disorders

• Conditions: Bariatric Surgery Candidate; Weight Loss

• Registration Number: NCT04575987
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-10-05
• Study Start: 2020-12-14
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-02
• Primary Completion: 2021-06-14
• Study Completion: 2021-06-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 709

Inclusion Criteria

• Women,
• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of the main PFD	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.

Trial Locations

Locations (1)

CHU de Poitiers; 🇫🇷 Poitiers, France