Weight LossNCT03882736
Volumetric Study of the Buttocks After Flap Augmentation in Buttocks Lifting
An observational study of Weight Loss, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The development of bariatric surgery, its effectiveness and the reduction of complications are at the origin of massive weight loss, the corollary of which has been a clear increase in the demands of treatment of sequelae of weight loss. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Weight Loss
- What is being tested?
- gluteal augmentation with flap in circumferential body lift
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2019to 30 Aug 2020
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Study population: patients after massiv weight loss who come in toulouse or montpellier hospital to take care of slimming effects
Who may be able to join
- 12 months minimum delay with bariatric surgery
- female, BMI<30kg/m2
- Age greater than or equal to 18 years
- Stable weight for more than 6 months
- lack of volume in gluteal region
- agree with clinical trial
Who cannot join
- Patient under tutorship or curatorship
- Pregnancy or breastfeeding
- hemoglobinemia< 12g/dL
- Albuminemia<3,5g/dL
- active smoking more than 1 month before surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of Volumetric Gluteal Region by Parasacral Perforator Flaps in Circumferential Body Lift
The development of bariatric surgery, its effectiveness and the reduction of complications are at the origin of massive weight loss, the corollary of which has been a clear increase in the demands of treatment of sequelae of weight loss.
- Conditions
- Weight Loss
- Being tested
- gluteal augmentation with flap in circumferential body lift
- Keywords
- plastic and reconstructive surgery, gluteal ptosis, platipygia
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gluteal augmentation with flap in circumferential body liftProcedure or surgery
classic circumferential bodylift surgery, using two different well-known flaps for gluteal augmentation
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric increase by para-sacral flap
evaluate the gluteal volume after augmentation with a parasacral flap using a 3D camera
Measured: day before the operation
Volumetric increase by para-sacral flap
evaluate the gluteal volume after augmentation with a parasacral flap using a 3D camera
Measured: then at the 3th month post surgery
Volumetric increase by para-sacral flap
evaluate the gluteal volume after augmentation with a parasacral flap using a 3D camera
Measured: then at the 6th month post surgery
Secondary outcomes (4)
Clinical evolution
Results of clinical evaluation : look for seroma andhematoma during hospitalization
Measured: During hospitalization (Day 0 to Day 5)
Results of clinical evolution
clinical evaluation : look for seroma and hematoma post surgery
Measured: Day 15
Results of clinical evolution
clinical evaluation : look for seroma and hematoma then at the 2nd week after surgery
Measured: 2nd week after surgery
Results of clinical evolution
clinical evaluation : look for seroma and hematoma then at 3rd week after surgery
Measured: 3rd week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start20 Feb 2019
- Primary completion20 Feb 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farid BEKARA, MD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882736
- Sponsor's protocol ID
- RECHMPL19_0036
- Status last verified
- Dec 2020
- First submitted
- 24 Jan 2019
- Last updated
- 29 Dec 2020
- 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 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Volumetric Gluteal Region by Parasacral Perforator Flaps in Circumferential Body Lift
- ClinicalTrials.gov ID
- NCT03882736
- Acronym / sponsor ID
- RECHMPL19_0036
- Conditions
- Weight Loss
- Keywords
- plastic and reconstructive surgery, gluteal ptosis, platipygia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 20 Mar 2019 (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.
The development of bariatric surgery, its effectiveness and the reduction of complications are at the origin of massive weight loss, the corollary of which has been a clear increase in the demands of treatment of sequelae of weight loss.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients after massiv weight loss who come in toulouse or montpellier hospital to take care of slimming effects
Key inclusion criteria (6 listed)
- 12 months minimum delay with bariatric surgery
- female, BMI<30kg/m2
- Age greater than or equal to 18 years
- Stable weight for more than 6 months
- lack of volume in gluteal region
Key exclusion criteria (5 listed)
- Patient under tutorship or curatorship
- Pregnancy or breastfeeding
- hemoglobinemia< 12g/dL
- Albuminemia<3,5g/dL
- active smoking more than 1 month before surgery
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 |
|---|---|---|
| gluteal augmentation with flap in circumferential body liftclassic circumferential bodylift surgery, using two different well-known flaps for gluteal augmentation | Procedure or surgery | – |
Primary outcome
Volumetric increase by para-sacral flap
Time frame: day before the operation
evaluate the gluteal volume after augmentation with a parasacral flap using a 3D camera
Volumetric increase by para-sacral flap
Time frame: then at the 3th month post surgery
evaluate the gluteal volume after augmentation with a parasacral flap using a 3D camera
Volumetric increase by para-sacral flap
Time frame: then at the 6th month post surgery
evaluate the gluteal volume after augmentation with a parasacral flap using a 3D camera
4 secondary outcomes
Clinical evolution
Time frame: During hospitalization (Day 0 to Day 5)
Results of clinical evolution
Time frame: Day 15
Results of clinical evolution
Time frame: 2nd week after surgery
Results of clinical evolution
Time frame: 3rd week after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
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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.
Farid BEKARA, MD study director
University Hospital, Montpellier
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 Weight Loss, run by University Hospital, Montpellier 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 29 Dec 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric increase by para-sacral flap (time frame: day before the operation). The study lists 3 primary outcomes in all. 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 29 Dec 2020.