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Volumetric Study of the Buttocks After Flap Augmentation in Buttocks Lifting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03777618
Recruitment Status : Completed
First Posted : December 17, 2018
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Weight Loss Procedure: gluteal augmentation with flap in circumferential body lift

Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Study of Volumetric Gluteal Region by Parasacral Perforator Flaps in Circuferential Body Lift
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : October 15, 2019
Actual Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Procedure: gluteal augmentation with flap in circumferential body lift
    classic circumferential bodylift surgery, using two differents well-known flaps for gluteal augmentation

Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Surgical complication [ Time Frame: 1 day ]
    Surgical complication during hospitalization, then 15 days after the operation and 1 month after the operation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients after massiv weight loss who come in toulouse or montpellier hospital to take care of slimming effects
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777618


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Director: Farid BEKARA, MD University Hospital, Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03777618    
Other Study ID Numbers: RECHMPL18_0239
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
plastic and reconstructive surgery
gluteal ptosis
platipygia
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight