Volumetric Study of the Buttocks After Flap Augmentation in Buttocks Lifting

NCT03882736 — Completed, 30 participants, University Hospital, Montpellier

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Prospective Study of Volumetric Gluteal Region by Parasacral Perforator Flaps in Circumferential Body Lift

Registry	NCT03882736
Status	Completed
Study type	Observational
Enrollment	30 (Actual)
Sponsor	University Hospital, Montpellier (Other)
Conditions	Weight Loss
Interventions	gluteal augmentation with flap in circumferential body lift (Procedure)
Dates	start 2019-02-20, primary completion 2020-02-20, completion 2020-08-30, first posted 2019-03-20, last updated 2020-12-29
Locations	1 site in France

-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.

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+Arms and interventions

gluteal augmentation with flap in circumferential body lift (Procedure): classic circumferential bodylift surgery, using two different well-known flaps for gluteal augmentation

+Outcome measures

Primary outcomes

Volumetric increase by para-sacral flap [day before the operation]: evaluate the gluteal volume after augmentation with a parasacral flap using a 3D camera
Volumetric increase by para-sacral flap [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 [then at the 6th month post surgery]: evaluate the gluteal volume after augmentation with a parasacral flap using a 3D camera

Secondary outcomes

Clinical evolution [During hospitalization (Day 0 to Day 5)]: Results of clinical evaluation : look for seroma andhematoma during hospitalization
Results of clinical evolution [Day 15]: clinical evaluation : look for seroma and hematoma post surgery
Results of clinical evolution [2nd week after surgery]: clinical evaluation : look for seroma and hematoma then at the 2nd week after surgery
Results of clinical evolution [3rd week after surgery]: clinical evaluation : look for seroma and hematoma then at 3rd week after surgery

+Eligibility

Sex: Female, ages: 18 Years to 60 Years

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 gluteal 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

+Locations (1)

Facility	City	Country	Status
Uhmontpellier	Montpellier	France

+Investigators

Farid BEKARA, MD, Study director, University Hospital, Montpellier

My Notes

Public

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