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OpenTrials
Completed

NCT Number: NCT03882736

Volumetric Study of the Buttocks After Flap Augmentation in Buttocks Lifting

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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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gluteal augmentation with flap in circumferential body lift

Procedure

classic circumferential bodylift surgery, using two different well-known flaps for gluteal augmentation

Primary outcomes

  1. Volumetric increase by para-sacral flap

    Time frame: day before the operation

    evaluate the gluteal volume after augmentation with a parasacral flap using a 3D camera

  2. Volumetric increase by para-sacral flap

    Time frame: then at the 3th month post surgery

    evaluate the gluteal volume after augmentation with a parasacral flap using a 3D camera

  3. Volumetric increase by para-sacral flap

    Time frame: then at the 6th month post surgery

    evaluate the gluteal volume after augmentation with a parasacral flap using a 3D camera

Secondary outcomes

  1. Clinical evolution

    Time frame: During hospitalization (Day 0 to Day 5)

    Results of clinical evaluation : look for seroma andhematoma during hospitalization

  2. Results of clinical evolution

    Time frame: Day 15

    clinical evaluation : look for seroma and hematoma post surgery

  3. Results of clinical evolution

    Time frame: 2nd week after surgery

    clinical evaluation : look for seroma and hematoma then at the 2nd week after surgery

  4. Results of clinical evolution

    Time frame: 3rd week after surgery

    clinical evaluation : look for seroma and hematoma then at 3rd week after surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 20, 2019
Registry last updated
Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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