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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Body Contouring
• Intervention / Treatment: Procedure: superior gluteal artery flap and lumbar artery falp; Procedure: The gluteal pocket; Procedure: infragluteal dermal lifiting flap

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mohammed kamal kamel, teaching assistant; Phone Number: +201068887912; Email: dr.mhmdkmal91@gmail.com
• Study Contact Backup: Name: assem hussien kamel, professor; Phone Number: +201005319242; Email: assemkamel88@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: 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.; 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.; 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.
Experimental: 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	Procedure: 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.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: November 9, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 30, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: body contouring

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No