Long Term Effect of Bariatric Surgery on Pelvic Floor Disorders

NCT04575987 | Unknown

• 1 other identifier: 2020-A02219-30
• Study Type: observational
• Target: 709
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate; Weight Loss

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Questionnaire OTHER

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women had a bariatric surgery in Poitiers university hospital center (France)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU de Poitiers

Poitiers, France

RECRUITING

MeSH Terms

Conditions

Weight Loss

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Océane CLERGUE

CONTACT

06.23.38.80.35; oceane.clergue@chu-poitiers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: October 5, 2020
• Study Start: December 14, 2020
• Primary Completion: June 14, 2021
• Study Completion: June 14, 2021
• Last Updated: February 2, 2021

Record last verified: 2021-01

Locations

FR (1)