Aesthetic Analysis of Gluteal Deformity After Weight Loss and Assessment the Role of Autologous Tissue Augmentation for Gluteal Contouring

NCT ID: NCT04167215

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2024-01-01

Brief Summary

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this study aim to evaluate the role of autologous augmentation for buttock contouring and analyze different aethetic gluteal deformity

Detailed Description

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The last decades showed an increasing demand for bariatric surgery and diet dependent massive weight loss , these successful strategies for weight loss result in significant deformities in general body contour , buttock normal appearance is very important for posterior trunk aesthetic image and its severely affected after massive weight loss .

Aesthetically attractive buttocks required special features include adequate volume, projection, and a defined infragluteal fold.. The gluteal region in patients with massive weight loss is characterized by excessive skin and exaggerated fat loss. Lower body lift procedures remove excess skin and lift sagging buttock tissue. unsatisfactory buttock shape especially V shaped buttock is considered as important indication for gluteal reshaping Mendieta and Cuenca-Guerra and Quezada have proposed novel methods of describing and analyzing gluteal aesthetics.

There are a multitude of options that can be used to improve the buttock includ-ing non-surgical injections, implants, fat, excisional, liposuction and various energy devices

Conditions

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Body Contouring

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

assessment the role of autologous augmentation in management of different buttock deformity by using either perforator flaps or fat injection
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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perforator flap augmentation

Doppler probe is used to locate perforating vessels from the superior gluteal artery. . Flaps or lumbar artery flap will be designed to allow deepithelialization and dissection laterally to medially to identify the perforator . then sketolization is performed A gluteal pocket will then create for the augmentation flaps by undermining in a plane just superficial to the gluteal muscle extending to within 5 cm of the inferior gluteal crease. The deepithelialized flaps will then transpose inferomedially , and tacked to the fascia with several sutures.to be used as autologus buttock augmentation flap

Group Type EXPERIMENTAL

superior gluteal artery flap and lumbar artery falp

Intervention Type PROCEDURE

Doppler ultrasound will be used to confirm location of the superior gluteal artery perforators or lumbar perforators . Flaps will be designed to allow deepithelialization and dissection . After complete sketolization of the flap it will be analyzed for viability and trimmed to achieve the desired bulk.

The gluteal pocket

Intervention Type PROCEDURE

pocket will be created by undermining in a plane just superficial to the gluteal muscle from the lower body lift line inferiorly extending to within 5 cm of the inferior gluteal crease. should extend only over the medial half of the buttock.

infragluteal dermal lifiting flap

Intervention Type PROCEDURE

dermal flap will be performed for lifting the ptotic buttocks with ill-defined infragluteal fold. This deepithelialized dermal flap allows for the creation of a well-defined stable infragluteal fold through an incision of the infragluteal fold and exposure of ischial tuberosity and anchor it to the ischial tuberosity.

fat injection

liposuction is performed firstly to parts where excess fat is exist and we will prepare the aspirated fat for injection as a graft in subcutaneous tissue of the buttock regoin

Group Type EXPERIMENTAL

superior gluteal artery flap and lumbar artery falp

Intervention Type PROCEDURE

Doppler ultrasound will be used to confirm location of the superior gluteal artery perforators or lumbar perforators . Flaps will be designed to allow deepithelialization and dissection . After complete sketolization of the flap it will be analyzed for viability and trimmed to achieve the desired bulk.

The gluteal pocket

Intervention Type PROCEDURE

pocket will be created by undermining in a plane just superficial to the gluteal muscle from the lower body lift line inferiorly extending to within 5 cm of the inferior gluteal crease. should extend only over the medial half of the buttock.

infragluteal dermal lifiting flap

Intervention Type PROCEDURE

dermal flap will be performed for lifting the ptotic buttocks with ill-defined infragluteal fold. This deepithelialized dermal flap allows for the creation of a well-defined stable infragluteal fold through an incision of the infragluteal fold and exposure of ischial tuberosity and anchor it to the ischial tuberosity.

Interventions

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superior gluteal artery flap and lumbar artery falp

Doppler ultrasound will be used to confirm location of the superior gluteal artery perforators or lumbar perforators . Flaps will be designed to allow deepithelialization and dissection . After complete sketolization of the flap it will be analyzed for viability and trimmed to achieve the desired bulk.

Intervention Type PROCEDURE

The gluteal pocket

pocket will be created by undermining in a plane just superficial to the gluteal muscle from the lower body lift line inferiorly extending to within 5 cm of the inferior gluteal crease. should extend only over the medial half of the buttock.

Intervention Type PROCEDURE

infragluteal dermal lifiting flap

dermal flap will be performed for lifting the ptotic buttocks with ill-defined infragluteal fold. This deepithelialized dermal flap allows for the creation of a well-defined stable infragluteal fold through an incision of the infragluteal fold and exposure of ischial tuberosity and anchor it to the ischial tuberosity.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Female patients.
* patients who are seeking for gluteal contouring after massive weight loss
* age above 18 years and fixed weight for 6months.

Exclusion Criteria

* Male patients
* Patients that will refuse the procedure,
* patients who thad a residual body mass index greater than 35
* patients have uncontrolled medical conditions.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Kamal Kamel

Teaching assistant plastic surgery departement

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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mohammed kamal kamel, teaching assistant

Role: CONTACT

+201068887912

assem hussien kamel, professor

Role: CONTACT

+201005319242

References

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Richter DF, Stoff A. Circumferential body contouring: the lower body lift. Clin Plast Surg. 2014 Oct;41(4):775-88. doi: 10.1016/j.cps.2014.07.004.

Reference Type BACKGROUND
PMID: 25283462 (View on PubMed)

Colwell AS, Borud LJ. Autologous gluteal augmentation after massive weight loss: aesthetic analysis and role of the superior gluteal artery perforator flap. Plast Reconstr Surg. 2007 Jan;119(1):345-356. doi: 10.1097/01.prs.0000244906.48448.5d.

Reference Type BACKGROUND
PMID: 17255692 (View on PubMed)

Centeno RF. Gluteal aesthetic unit classification: a tool to improve outcomes in body contouring. Aesthet Surg J. 2006 Mar-Apr;26(2):200-8. doi: 10.1016/j.asj.2006.01.001.

Reference Type BACKGROUND
PMID: 19338900 (View on PubMed)

Pascal JF, Le Louarn C. Remodeling bodylift with high lateral tension. Aesthetic Plast Surg. 2002 May-Jun;26(3):223-30. doi: 10.1007/s00266-002-1478-z.

Reference Type BACKGROUND
PMID: 12140705 (View on PubMed)

Gonzalez-Ulloa M. Torsoplasty. Aesthetic Plast Surg. 1979 Dec;3(1):357-68. doi: 10.1007/BF01577875.

Reference Type BACKGROUND
PMID: 24174007 (View on PubMed)

Offman SL, Geddes CR, Tang M, Morris SF. The vascular basis of perforator flaps based on the source arteries of the lateral lumbar region. Plast Reconstr Surg. 2005 May;115(6):1651-9. doi: 10.1097/01.prs.0000161464.11134.c1.

Reference Type BACKGROUND
PMID: 15861070 (View on PubMed)

Other Identifiers

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body contouring

Identifier Type: -

Identifier Source: org_study_id

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