Bariatric Surgery CandidateICONESNCT04575987
Long Term Effect of Bariatric Surgery on Pelvic Floor Disorders
An observational study of Bariatric Surgery Candidate and Weight Loss, run by Poitiers University Hospital at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Bariatric Surgery Candidate, Weight Loss
- What is being tested?
- Questionnaire
- How many people
- 709 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2020to 14 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Women had a bariatric surgery in Poitiers university hospital center (France)
Who may be able to join
- 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.
Who cannot join
- to be under guardianship or tutelage measures
- to express opposition to participate to this study.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Poitiers
Poitiers
Océane CLERGUE, oceane.clergue@chu-poitiers.fr
About this study
Official title: How Bariatric Surgery Impacts Pelvic Floor Disorders Evolution : Analysis on a Cohort From a French Hospital.
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
- Being tested
- Questionnaire
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: minimum 18 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start14 Dec 2020
- Primary completion14 Jun 2021 (estimated)
- Study completion14 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 709 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575987
- Sponsor's protocol ID
- 2020-A02219-30
- Acronym
- ICONES
- Status last verified
- Jan 2021
- First submitted
- 16 Sep 2020
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Bariatric Surgery Impacts Pelvic Floor Disorders Evolution : Analysis on a Cohort From a French Hospital.
- ClinicalTrials.gov ID
- NCT04575987
- Acronym / sponsor ID
- ICONES / 2020-A02219-30
- Conditions
- Bariatric Surgery Candidate, Weight Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 709 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 14 Jun 2021 (estimated)
- Study completion
- 14 Jun 2021 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women had a bariatric surgery in Poitiers university hospital center (France)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- to be under guardianship or tutelage measures
- to express opposition to participate to this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaires 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. | Other | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate and Weight Loss, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Océane CLERGUE (06.23.38.80.35, oceane.clergue@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of the main PFD (time frame: minimum 18 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.