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NCT04575987 Clinical Trial

Long Term Effect of Bariatric Surgery on Pelvic Floor Disorders

Weight Loss Clinical Trial

— ICONES  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04575987
Other study ID # 2020-A02219-30
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 14, 2020
Est. completion date June 14, 2021

Study information
Verified date January 2021
Source Poitiers University Hospital
Contact Océane CLERGUE
Phone 06.23.38.80.35
Email oceane.clergue@chu-poitiers.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 709
Est. completion date June 14, 2021
Est. primary completion date June 14, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaire
Questionnaires will be sent by email or by post, in which questions about PFD, obstetrical history or dietetic follow-up will be asked. Some obstetrical issues will be get from women medical files.

Locations
Country Name City State
France CHU de Poitiers Poitiers

Sponsors (1)
Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of the main PFD 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.		 minimum 18 months after surgery
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