- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03777618
Volumetric Study of the Buttocks After Flap Augmentation in Buttocks Lifting
November 18, 2019 updated by: University Hospital, Montpellier
Retrospective Study of Volumetric Gluteal Region by Parasacral Perforator Flaps in Circuferential 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Montpellier, France, 34295
- Uhmontpellier
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
patients after massiv weight loss who come in toulouse or montpellier hospital to take care of slimming effects
Description
Inclusion criteria:
- 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 gluetal region
- agree with clinical trial
Exclusion criteria:
- Patient under tutorship or curatorship
- Pregnancy or breastfeeding
- hemoglobinemia< 12g/dL
- Albuminemia<3,5g/dL
- active smoking more than 1 month before surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
evaluate gluteal volume
Time Frame: 1 day
|
evaluate the gluteal volume after augmentation with a parasacral flap using a 3D camera between the preoperative and at 2 months after surgery and 3 months after surgery
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgical complication
Time Frame: 1 day
|
Surgical complication during hospitalization, then 15 days after the operation and 1 month after the operation
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2018
Primary Completion (Actual)
October 15, 2019
Study Completion (Actual)
October 30, 2019
Study Registration Dates
First Submitted
September 28, 2018
First Submitted That Met QC Criteria
December 14, 2018
First Posted (Actual)
December 17, 2018
Study Record Updates
Last Update Posted (Actual)
November 19, 2019
Last Update Submitted That Met QC Criteria
November 18, 2019
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL18_0239
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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