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

Primary Purpose

Body Contouring

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
superior gluteal artery flap and lumbar artery falp
The gluteal pocket
infragluteal dermal lifiting flap
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Body Contouring

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    perforator flap augmentation

    fat injection

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    Analysis of different gluteal deformity as regarding gluteal projection ptosis and waist hip ratio.
    Analysis of gluteal projection will be performed using Gonzalez-ulloa method , four points and two distances , (A) Greater trochanter, (B) Point of maximal projection of the mons , (C) Point of maximal gluteal projection, (D) Anterior superior iliac spine. The CB line points to the maximal ideal projection of the buttocks. The ideal proportion is a 2:1 ratio between AB and AC.
    Analysis of gluteal deformity after massive weight loss regarding gluteal ptosis
    buttock ptosis: Gonzalez system will be used for analysis Through two lines one crossing the ischial tuber, "T" line, other crossing the mid thigh "M" lin.degrees from 0 to 7 degrees according to the definition of the crease from T to M line and the ptotic tissue surpasses the gluteal crease caudally in centimeters .
    Analysis of gluteal deformity after massive weight loss regarding waist hip ratio.
    Waist hip ratio assessment The ideal female figure has a waist-to-hip ratio of 0.7. The ration is measured in posterior view and in lateral view with the most pleasing ratio 0.65 and 0.7 respectively. WHO recommendation for WHR measure ; while patient being in the standing position parallel to the floor at the level at which the measurement is made and using a stretch-resistant tape and placement of the tape The measurement should be taken around the widest portion of the buttocks. at two definite point for the waist and the hip . For waist circumference: The measurement is made at the approximate midpoint between the lower margin of the last palpable rib and the top of the iliac crest. For hip circumference: The measurement should be taken around the widest portion of the buttocks.
    Assessment the role of autologous flaps for gluteal contouring.
    aesthetic analysis of the cases is described using photography and contour measures to outline the effect of the autologous flap in contour correction . In addition to complete review of perioperative and postoperative complications will be documented.
    patient satisfaction from surgery .
    Patients will be asked to rate the improvement of the appearance of the buttock area and their overall satisfaction with that aspect of the surgery on a 1 (no improvement) to 5 (extremely satisfied) scale
    surgery complications.
    complete review of perioperative and postoperative complications will be documented.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 9, 2019
    Last Updated
    March 30, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04167215
    Brief Title
    Aesthetic Analysis of Gluteal Deformity After Weight Loss and Assessment the Role of Autologous Tissue Augmentation for Gluteal Contouring
    Official Title
    Aesthetic Analysis of Gluteal Deformity After Weight Loss and Assessment the Role of Autologous Tissue Augmentation for Gluteal Contouring
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2021 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    January 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Body Contouring

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    assessment the role of autologous augmentation in management of different buttock deformity by using either perforator flaps or fat injection
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    perforator flap augmentation
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    fat injection
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    superior gluteal artery flap and lumbar artery falp
    Intervention Description
    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
    Intervention Name(s)
    The gluteal pocket
    Intervention Description
    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
    Intervention Name(s)
    infragluteal dermal lifiting flap
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Analysis of different gluteal deformity as regarding gluteal projection ptosis and waist hip ratio.
    Description
    Analysis of gluteal projection will be performed using Gonzalez-ulloa method , four points and two distances , (A) Greater trochanter, (B) Point of maximal projection of the mons , (C) Point of maximal gluteal projection, (D) Anterior superior iliac spine. The CB line points to the maximal ideal projection of the buttocks. The ideal proportion is a 2:1 ratio between AB and AC.
    Time Frame
    2 years
    Title
    Analysis of gluteal deformity after massive weight loss regarding gluteal ptosis
    Description
    buttock ptosis: Gonzalez system will be used for analysis Through two lines one crossing the ischial tuber, "T" line, other crossing the mid thigh "M" lin.degrees from 0 to 7 degrees according to the definition of the crease from T to M line and the ptotic tissue surpasses the gluteal crease caudally in centimeters .
    Time Frame
    2 years
    Title
    Analysis of gluteal deformity after massive weight loss regarding waist hip ratio.
    Description
    Waist hip ratio assessment The ideal female figure has a waist-to-hip ratio of 0.7. The ration is measured in posterior view and in lateral view with the most pleasing ratio 0.65 and 0.7 respectively. WHO recommendation for WHR measure ; while patient being in the standing position parallel to the floor at the level at which the measurement is made and using a stretch-resistant tape and placement of the tape The measurement should be taken around the widest portion of the buttocks. at two definite point for the waist and the hip . For waist circumference: The measurement is made at the approximate midpoint between the lower margin of the last palpable rib and the top of the iliac crest. For hip circumference: The measurement should be taken around the widest portion of the buttocks.
    Time Frame
    2 years
    Title
    Assessment the role of autologous flaps for gluteal contouring.
    Description
    aesthetic analysis of the cases is described using photography and contour measures to outline the effect of the autologous flap in contour correction . In addition to complete review of perioperative and postoperative complications will be documented.
    Time Frame
    2 years
    Title
    patient satisfaction from surgery .
    Description
    Patients will be asked to rate the improvement of the appearance of the buttock area and their overall satisfaction with that aspect of the surgery on a 1 (no improvement) to 5 (extremely satisfied) scale
    Time Frame
    2 years
    Title
    surgery complications.
    Description
    complete review of perioperative and postoperative complications will be documented.
    Time Frame
    2 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    mohammed kamal kamel, teaching assistant
    Phone
    +201068887912
    Email
    dr.mhmdkmal91@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    assem hussien kamel, professor
    Phone
    +201005319242
    Email
    assemkamel88@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25283462
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17255692
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19338900
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12140705
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24174007
    Citation
    Gonzalez-Ulloa M. Torsoplasty. Aesthetic Plast Surg. 1979 Dec;3(1):357-68. doi: 10.1007/BF01577875.
    Results Reference
    background
    PubMed Identifier
    15861070
    Citation
    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.
    Results Reference
    background

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