NCT04167215

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Status
unknown

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

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
1.5 years until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

2.6 years

First QC Date

November 9, 2019

Last Update Submit

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

EXPERIMENTAL

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 falpProcedure: The gluteal pocketProcedure: infragluteal dermal lifiting flap

fat injection

EXPERIMENTAL

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 falpProcedure: The gluteal pocketProcedure: infragluteal dermal lifiting flap

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.

fat injectionperforator flap augmentation

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.

fat injectionperforator flap augmentation

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 injectionperforator flap augmentation

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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: 25283462BACKGROUND
  • 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.

    PMID: 17255692BACKGROUND
  • 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.

    PMID: 19338900BACKGROUND
  • 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.

    PMID: 12140705BACKGROUND
  • Gonzalez-Ulloa M. Torsoplasty. Aesthetic Plast Surg. 1979 Dec;3(1):357-68. doi: 10.1007/BF01577875.

    PMID: 24174007BACKGROUND
  • 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.

    PMID: 15861070BACKGROUND

Central Study Contacts

mohammed kamal kamel, teaching assistant

CONTACT

assem hussien kamel, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: assessment the role of autologous augmentation in management of different buttock deformity by using either perforator flaps or fat injection
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