Long Term Effect of Bariatric Surgery on Pelvic Floor Disorders

NCT ID: NCT04575987

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

709 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-14

Study Completion Date

2021-06-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bariatric Surgery Candidate Weight Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de Poitiers

Poitiers, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Océane CLERGUE

Role: CONTACT

06.23.38.80.35

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Océane CLERGUE

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-A02219-30

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of Bariatric Surgery
NCT02857179 RECRUITING
Outpatient Bariatric Surgery
NCT04423575 COMPLETED NA