Aesthetic Analysis of Gluteal Deformity After Weight Loss and Assessment the Role of Autologous Tissue Augmentation for Gluteal Contouring
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
this study aim to evaluate the role of autologous augmentation for buttock contouring and analyze different aethetic gluteal deformity
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2021
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2019
CompletedFirst Posted
Study publicly available on registry
November 18, 2019
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedApril 1, 2021
March 1, 2021
2.6 years
November 9, 2019
March 30, 2021
Conditions
Outcome Measures
Primary Outcomes (6)
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.
2 years
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 .
2 years
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.
2 years
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.
2 years
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
2 years
surgery complications.
complete review of perioperative and postoperative complications will be documented.
2 years
Study Arms (2)
perforator flap augmentation
EXPERIMENTALDoppler 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
fat injection
EXPERIMENTALliposuction 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
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Female patients.
- patients who are seeking for gluteal contouring after massive weight loss
- age above 18 years and fixed weight for 6months.
You may not qualify if:
- Male patients
- Patients that will refuse the procedure,
- patients who thad a residual body mass index greater than 35
- patients have uncontrolled medical conditions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (6)
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.
PMID: 25283462BACKGROUNDColwell 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.
PMID: 17255692BACKGROUNDCenteno 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.
PMID: 19338900BACKGROUNDPascal 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.
PMID: 12140705BACKGROUNDGonzalez-Ulloa M. Torsoplasty. Aesthetic Plast Surg. 1979 Dec;3(1):357-68. doi: 10.1007/BF01577875.
PMID: 24174007BACKGROUNDOffman 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.
PMID: 15861070BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Teaching assistant plastic surgery departement
Study Record Dates
First Submitted
November 9, 2019
First Posted
November 18, 2019
Study Start
May 1, 2021
Primary Completion
December 1, 2023
Study Completion
January 1, 2024
Last Updated
April 1, 2021
Record last verified: 2021-03