Volumetric Study of the Buttocks After Flap Augmentation in Buttocks Lifting

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03882736
• Other study ID #: RECHMPL19_0036
• Status: Completed
• Start date: February 20, 2019
• Est. completion date: August 30, 2020

Study information

• Verified date: December 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 30, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Weight Loss

Intervention

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

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volumetric increase by para-sacral flap	evaluate the gluteal volume after augmentation with a parasacral flap using a 3D camera	day before the operation
Primary	Volumetric increase by para-sacral flap	evaluate the gluteal volume after augmentation with a parasacral flap using a 3D camera	then at the 3th month post surgery
Primary	Volumetric increase by para-sacral flap	evaluate the gluteal volume after augmentation with a parasacral flap using a 3D camera	then at the 6th month post surgery
Secondary	Clinical evolution	Results of clinical evaluation : look for seroma andhematoma during hospitalization	During hospitalization (Day 0 to Day 5)
Secondary	Results of clinical evolution	clinical evaluation : look for seroma and hematoma post surgery	Day 15
Secondary	Results of clinical evolution	clinical evaluation : look for seroma and hematoma then at the 2nd week after surgery	2nd week after surgery
Secondary	Results of clinical evolution	clinical evaluation : look for seroma and hematoma then at 3rd week after surgery	3rd week after surgery