Thigh Lipodystrophythigh liftNCT03283475
Different Surgical Modalities for Thigh Lipodystrophy Including Liposuction,Thigh Lift and Liposuction Assisted Thigh Lift
A study testing thigh lift in people with Thigh Lipodystrophy, run by Assiut University at 1 site in Egypt.
Trial summary
The sample will be divided into two groups:- - Control group which will include 60 adult individuals between 18 and 35 years old who have BMI between 19 and 25, not complaining of any thigh contour deformities or skin redundancy with no history of body weight fluctuations. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Thigh Lipodystrophy
- What is being tested?
- thigh lift
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 14 May 2017to 1 Apr 2019
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals between18 and 35 years for control group and more than 18 years for patient group .
- Patients with BMI between 19 and 25 for control group and less than 35 for patient group.
Who cannot join
- Individuals less than 18 years.
- Patients undergoing bariatric surgery within a period of less than one year.
- Patients with BMI more than 35.
- Patients with systemic illness as cancer or mental disorders \& hepatic patients (generally debilitating diseases) or any contraindication for anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Management of Thigh Lipodystrophy
The sample will be divided into two groups:- - Control group which will include 60 adult individuals between 18 and 35 years old who have BMI between 19 and 25, not complaining of any thigh contour deformities or skin redundancy with no history of body weight fluctuations. This group will be divided into two subgroups, 30 males and 30 females.
The following measurements will be recorded :- Weight, height, thigh length, hip circumference, maximum buttocks circumference, upper thigh, middle thigh and lower thigh circumferences.
Read more
- Patient group which will include 40 patients suffering from thigh lipodystrophy and contour deformities who will undergo surgical intervention after their assessment.
After assessment, one of the following techniques will be selected:-
- Liposuction only.
- thigh lift.
- Liposuction assisted thigh lift.
Read the detailed description
Preoperative assessment:- Patients will be assessed regarding skin redundancy, history of weight loss and site of lipodystrophy whether deformity is proximal, distal or diffuse.
The same measurements mentioned above will be recorded for the patient group before surgery.
Preoperative photographs in anteroposterior, lateral and oblique positions will be taken.
Informed consent will be signed by the patient before surgery illustrating possible risks and complications of the surgery.
Postoperative assessment:- The outcomes will be evaluated 3 months after surgery regarding patient satisfaction and achievement of symmetry.
Early complications will be assessed within one week after surgery including hematoma, seroma, surgical site infection and wound dehiscence.
Late complications will be assessed at 3 months follow up including asymmetry, conspicuous scar and lymphedema.
Postoperative measurements and photographs will be recorded and compared with preoperative ones.
- Conditions
- Thigh Lipodystrophy
- Being tested
- thigh lift
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thigh liftProcedure or surgery
Also called thigh liposuction, liposuction assisted thigh lift
liposuction-assisted medial avulsion thighplasty enables technically refined contouring of the thigh and the possible preservation of the local microvasculature, which results in reduced complication rates
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | - Control group will include 60 adult individuals between 18 and 35 years old who have body mass index (BMI) between 19 and 25, not complaining of any thigh contour deformities or skin redundancy with no history of body weight fluctuations. This group will be divided into two subgroups, 30 males and 30 females. The following measurements will be recorded :- Weight, height, thigh length, hip circumference, maximum buttocks circumference, upper thigh, middle thigh and lower thigh circumferences. |
| patient group | Active comparator | - Patient group will include 30 patients suffering from thigh lipodystrophy and contour deformities who will undergo surgical intervention after their assessment.
After assessment, one of the following techniques will be selected:-
* Liposuction only.
* thigh lift.
* Liposuction assisted thigh lift. Receives: Procedure: thigh lift |
What is being measured
The primary outcome is the main question the study is designed to answer.
regarding patient satisfaction and achievement of symmetry.
questionnaire will be performed for the patient group to estimate degree of patient satisfaction with assessment of postoperative symmetry
Measured: 3 months
Secondary outcomes (1)
complication rates of different surgical techniques
Early complications will be assessed within one week after surgery including hematoma, seroma, surgical site infection and wound dehiscence.
Late complications will be assessed at 3 months follow up including asymmetry, conspicuous scar and lymphedema.
Measured: 1 week and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start14 May 2017
- Primary completion22 Oct 2018 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thigh LipodystrophyStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- The sample will be divided into two groups:- - Control group which will include 60 adult individuals between 18 and 35 years old who have BMI between 19 and 25, not complaining of any thigh contour deformities or skin redundancy with no history of body weight fluctuations. This group will be divided into two subgroups, 30 males and 30 females. The following measurements will be recorded :- Weight, height, thigh length, hip circumference, maximum buttocks circumference, upper thigh, middle thigh and lower thigh circumferences. \- Patient group which will include 40 patients suffering from thigh lipodystrophy and contour deformities who will undergo surgical intervention after their assessment. After assessment, one of the following techniques will be selected:- * Liposuction only. * thigh lift. * Liposuction assisted thigh lift.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Gamal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283475
- Sponsor's protocol ID
- 13111987
- Acronym
- thigh lift
- Status last verified
- Sep 2017
- First submitted
- 13 Sep 2017
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cabbabe SW. Plastic Surgery after Massive Weight Loss. Mo Med. 2016 May-Jun;113(3):202-6.
PubMed 27443046Schmidt M, Pollhammer MS, Januszyk M, Duscher D, Huemer GM. Concomitant Liposuction Reduces Complications of Vertical Medial Thigh Lift in Massive Weight Loss Patients. Plast Reconstr Surg. 2016 Jun;137(6):1748-1757. doi: 10.1097/PRS.0000000000002194.
PubMed 27219231
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Management of Thigh Lipodystrophy
- ClinicalTrials.gov ID
- NCT03283475
- Acronym / sponsor ID
- thigh lift / 13111987
- Conditions
- Thigh Lipodystrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 14 May 2017 (actual)
- Primary completion
- 22 Oct 2018 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 14 Sep 2017 (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.
The sample will be divided into two groups:- - Control group which will include 60 adult individuals between 18 and 35 years old who have BMI between 19 and 25, not complaining of any thigh contour deformities or skin redundancy with no history of body weight fluctuations. This group will be divided into two subgroups, 30 males and 30 females.
The following measurements will be recorded :- Weight, height, thigh length, hip circumference, maximum buttocks circumference, upper thigh, middle thigh and lower thigh circumferences.
- Patient group which will include 40 patients suffering from thigh lipodystrophy and contour deformities who will undergo surgical intervention after their assessment.
After assessment, one of the following techniques will be selected:-
- Liposuction only.
- thigh lift.
- Liposuction assisted thigh lift.
Detailed description
Preoperative assessment:- Patients will be assessed regarding skin redundancy, history of weight loss and site of lipodystrophy whether deformity is proximal, distal or diffuse.
The same measurements mentioned above will be recorded for the patient group before surgery.
Preoperative photographs in anteroposterior, lateral and oblique positions will be taken.
Informed consent will be signed by the patient before surgery illustrating possible risks and complications of the surgery.
Postoperative assessment:- The outcomes will be evaluated 3 months after surgery regarding patient satisfaction and achievement of symmetry.
Early complications will be assessed within one week after surgery including hematoma, seroma, surgical site infection and wound dehiscence.
Late complications will be assessed at 3 months follow up including asymmetry, conspicuous scar and lymphedema.
Postoperative measurements and photographs will be recorded and compared with preoperative ones.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The sample will be divided into two groups:- - Control group which will include 60 adult individuals between 18 and 35 years old who have BMI between 19 and 25, not complaining of any thigh contour deformities or skin redundancy with no history of body weight fluctuations. This group will be divided into two subgroups, 30 males and 30 females. The following measurements will be recorded :- Weight, height, thigh length, hip circumference, maximum buttocks circumference, upper thigh, middle thigh and lower thigh circumferences. - Patient group which will include 40 patients suffering from thigh lipodystrophy and contour deformities who will undergo surgical intervention after their assessment. After assessment, one of the following techniques will be selected:- * Liposuction only. * thigh lift. * Liposuction assisted thigh lift.
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –- Control group will include 60 adult individuals between 18 and 35 years old who have body mass index (BMI) between 19 and 25, not complaining of any thigh contour deformities or skin redundancy with no history of body weight fluctuations. This group will be divided into two subgroups, 30 males and 30 females. The following measurements will be recorded :- Weight, height, thigh length, hip circumference, maximum buttocks circumference, upper thigh, middle thigh and lower thigh circumferences. |
| patient group | Active comparator | Procedure: thigh lift- Patient group will include 30 patients suffering from thigh lipodystrophy and contour deformities who will undergo surgical intervention after their assessment. After assessment, one of the following techniques will be selected:- * Liposuction only. * thigh lift. * Liposuction assisted thigh lift. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Individuals between18 and 35 years for control group and more than 18 years for patient group .
- Patients with BMI between 19 and 25 for control group and less than 35 for patient group.
Key exclusion criteria (4 listed)
- Individuals less than 18 years.
- Patients undergoing bariatric surgery within a period of less than one year.
- Patients with BMI more than 35.
- Patients with systemic illness as cancer or mental disorders \& hepatic patients (generally debilitating diseases) or any contraindication for anesthesia.
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 |
|---|---|---|
| thigh liftAlso: thigh liposuction, liposuction assisted thigh liftliposuction-assisted medial avulsion thighplasty enables technically refined contouring of the thigh and the possible preservation of the local microvasculature, which results in reduced complication rates | Procedure or surgery | patient group |
Primary outcome
regarding patient satisfaction and achievement of symmetry.
Time frame: 3 months
questionnaire will be performed for the patient group to estimate degree of patient satisfaction with assessment of postoperative symmetry
1 secondary outcome
complication rates of different surgical techniques
Time frame: 1 week and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Background: PubMed 27443046Cabbabe SW. Plastic Surgery after Massive Weight Loss. Mo Med. 2016 May-Jun;113(3):202-6.
- Results publication: PubMed 27219231Schmidt M, Pollhammer MS, Januszyk M, Duscher D, Huemer GM. Concomitant Liposuction Reduces Complications of Vertical Medial Thigh Lift in Massive Weight Loss Patients. Plast Reconstr Surg. 2016 Jun;137(6):1748-1757. doi: 10.1097/PRS.0000000000002194.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thigh lift in people with Thigh Lipodystrophy, run by Assiut University at 1 site in Egypt.
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 2 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 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
regarding patient satisfaction and achievement of symmetry. (time frame: 3 months). 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 NCT03283475, which also lists 2 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 14 Sep 2017; AzTrials last refreshed its copy on 2 Nov 2026.