Body ContouringNCT04167215
Aesthetic Analysis of Gluteal Deformity After Weight Loss and Assessment the Role of Autologous Tissue Augmentation for Gluteal Contouring
A study testing superior gluteal artery flap and lumbar artery falp, The gluteal pocket and infragluteal dermal lifiting flap in people with Body Contouring, run by Assiut University.
Trial summary
this study aim to evaluate the role of autologous augmentation for buttock contouring and analyze different aethetic gluteal deformity Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Body Contouring
- What is being tested?
- superior gluteal artery flap and lumbar artery falp, The gluteal pocket and infragluteal dermal lifiting flap
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients.
- patients who are seeking for gluteal contouring after massive weight loss
- age above 18 years and fixed weight for 6months.
Who cannot join
- Male patients
- Patients that will refuse the procedure,
- patients who thad a residual body mass index greater than 35
- patients have uncontrolled medical conditions.
Trial locations and contacts
No sites are listed yet.
About this study
this study aim to evaluate the role of autologous augmentation for buttock contouring and analyze different aethetic gluteal deformity
Read the 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
- Conditions
- Body Contouring
- Being tested
- superior gluteal artery flap and lumbar artery falp, The gluteal pocket, infragluteal dermal lifiting flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
superior gluteal artery flap and lumbar artery falpProcedure or surgery
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 pocketProcedure or surgery
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 flapProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: superior gluteal artery flap and lumbar artery falp; Procedure: The gluteal pocket; Procedure: 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 Receives: Procedure: superior gluteal artery flap and lumbar artery falp; Procedure: The gluteal pocket; Procedure: infragluteal dermal lifiting flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: 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
Measured: 2 years
surgery complications.
complete review of perioperative and postoperative complications will be documented.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start1 May 2021 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Body ContouringStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Kamal Kamel, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167215
- Sponsor's protocol ID
- body contouring
- Status last verified
- Mar 2021
- First submitted
- 9 Nov 2019
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 25283462Colwell 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.
PubMed 17255692Centeno 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.
PubMed 19338900Pascal 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.
PubMed 12140705Gonzalez-Ulloa M. Torsoplasty. Aesthetic Plast Surg. 1979 Dec;3(1):357-68. doi: 10.1007/BF01577875.
PubMed 24174007Offman 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.
PubMed 15861070
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aesthetic Analysis of Gluteal Deformity After Weight Loss and Assessment the Role of Autologous Tissue Augmentation for Gluteal Contouring
- ClinicalTrials.gov ID
- NCT04167215
- Acronym / sponsor ID
- body contouring
- Conditions
- Body Contouring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- assessment the role of autologous augmentation in management of different buttock deformity by using either perforator flaps or fat injection
| Arm | Type | Receives |
|---|---|---|
| perforator flap augmentation | Experimental | Procedure: superior gluteal artery flap and lumbar artery falp, Procedure: The gluteal pocket, Procedure: infragluteal dermal lifiting flapDoppler 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 | Experimental | Procedure: superior gluteal artery flap and lumbar artery falp, Procedure: The gluteal pocket, Procedure: infragluteal dermal lifiting flapliposuction 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female patients.
- patients who are seeking for gluteal contouring after massive weight loss
- age above 18 years and fixed weight for 6months.
Key exclusion criteria (4 listed)
- Male patients
- Patients that will refuse the procedure,
- patients who thad a residual body mass index greater than 35
- patients have uncontrolled medical conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| superior gluteal artery flap and lumbar artery falpDoppler 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 or surgery | fat injection, perforator flap augmentation |
| The gluteal pocketpocket 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 or surgery | fat injection, perforator flap augmentation |
| infragluteal dermal lifiting flapdermal 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. | Procedure or surgery | fat injection, perforator flap augmentation |
Primary outcome
Analysis of different gluteal deformity as regarding gluteal projection ptosis and waist hip ratio.
Time frame: 2 years
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
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
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 .
Time frame: 2 years
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.
Time frame: 2 years
complete review of perioperative and postoperative complications will be documented.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Background: PubMed 25283462Richter 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.
- Background: PubMed 17255692Colwell 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.
- Background: PubMed 19338900Centeno 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.
- Background: PubMed 12140705Pascal 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.
- Background: PubMed 24174007Gonzalez-Ulloa M. Torsoplasty. Aesthetic Plast Surg. 1979 Dec;3(1):357-68. doi: 10.1007/BF01577875.
- Background: PubMed 15861070Offman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing superior gluteal artery flap and lumbar artery falp, The gluteal pocket and infragluteal dermal lifiting flap in people with Body Contouring, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohammed kamal kamel, teaching assistant (+201068887912, dr.mhmdkmal91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of different gluteal deformity as regarding gluteal projection ptosis and waist hip ratio. (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04167215, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.