Volumetric Study of the Buttocks After Flap Augmentation in Buttocks Lifting

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss
• Intervention / Treatment: Procedure: gluteal augmentation with flap in circumferential body lift

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

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 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volumetric increase by para-sacral flap	evaluate the gluteal volume after augmentation with a parasacral flap using a 3D camera	day before the operation
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 20, 2019
• Primary Completion (ACTUAL): February 20, 2020
• Study Completion (ACTUAL): August 30, 2020

Study Registration Dates

• First Submitted: January 24, 2019
• First Submitted That Met QC Criteria: March 18, 2019
• First Posted (ACTUAL): March 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: plastic and reconstructive surgery; gluteal ptosis; platipygia
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: RECHMPL19_0036

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No