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NCT03777618 Clinical Trial

Volumetric Study of the Buttocks After Flap Augmentation in Buttocks Lifting

Weight Loss Clinical Trial

Official title:
Retrospective Study of Volumetric Gluteal Region by Parasacral Perforator Flaps in Circuferential Body Lift

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03777618
Other study ID # RECHMPL18_0239
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date October 30, 2019

Study information
Verified date September 2018
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
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 October 30, 2019
Est. primary completion date October 15, 2019
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 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• gluteal augmentation with flap in circumferential body lift
classic circumferential bodylift surgery, using two differents 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 evaluate gluteal volume 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 Surgical complication Surgical complication during hospitalization, then 15 days after the operation and 1 month after the operation 1 day
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