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LymphedemaPhase 1Thight_liftNCT01470378

Manual Lymphatic Drainage in Women Undergone to Thigh Lifting

A Phase 1 study testing Thigh Surgery in people with Lymphedema and Obesity, run by Federal University of São Paulo at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will investigate the subcutaneous tissue changes in the lymphedema found after thigh surgery, by circumferential measure of thr thighs and by magnetic resonance imaging verifying the effects of postoperative lymphatic drainage. Read more about this study

Who is it for?
Ages 30 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Lymphedema, Obesity
What is being tested?
Thigh Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteBrazil
Study dates
Jan 2011to Nov 2013
Phase
Phase 1
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 30 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Female patients
  • Age between 30 and 60 years old
  • Bariatric Surgery Capella Previous Type
  • Stabilization of weight loss for 1 year or more
  • Patients with a body mass index less than or equal to 30 kg/m2

Who cannot join

  • Pregnancy, childbirth or breastfeeding for less than 1 year
  • Presence of uncontrolled systemic disease
  • Other disease that require surgical interventions
  • Lymphatic or venous pathologies in advance
  • Patients over 110 kg
  • Patients with a body mass index(BMI) greater than 30 kg/m2
  • Patients who has undergone plastic surgery of the thighs

Trial locations and contacts

1 site in 1 country.

Brazil1 site, 1 recruiting

  • Federal University of Sao Paulo

    São Paulo, São Paulo, 04023-900

    Elvio B Garcia, MD, 551155739525, elvio@uol.com.br

    Lilia C Arruda, PhD, 551150965996

    Recruiting

Other trials in Brazil

About this study

Official title: Manual Lymphatic Drainage in Women Undergone to Thigh Lifting After Bariatric Surgery

This study will investigate the subcutaneous tissue changes in the lymphedema found after thigh surgery, by circumferential measure of thr thighs and by magnetic resonance imaging verifying the effects of postoperative lymphatic drainage.

Read the detailed description

Patients will be invited to participate in the study, divided into two groups, and randomized to treatment by wwww.randomization.com, where 10 patients will participate in the study group(20 legs) and 10 control group patients(20 legs). Total of 40 legs. Then, the evaluation will be performed on preoperative time, consisting of physical examination and circumferential measures. Others measurements will be taken im postoperative time and confirmed by magnetic resonance.

Conditions
Lymphedema, Obesity
Being tested
Thigh Surgery
Keywords
Lymphedema, Magnetic Resonance Imaging, Plastic Surgery
Medical subject headings
Lymphedema, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thigh SurgeryProcedure or surgery

    Also called Thigh plastic surgery, Postobesity surgery

    Circumferential thigh surgery post bariatric surgery

Study groups in NCT01470378
Study groupRoleWhat they receive
Control GroupActive comparatorThis group will not be undergoing to manual lymphatic drainage
Receives: Procedure: Thigh Surgery
Study GroupActive comparatorThis group will be undergoing to manual lymphatic drainage
Receives: Procedure: Thigh Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Preoperative measurement.

    Thigh circumference measurements made with anthropometric metal tape and a Permanent Marker, based in bone parameters in supine position. Using as reference the bony protuberance of the trochanter, the first measurement will be taken 5 (five) cm below this point and 5 (five) cm above the patella, and betwin this two points will be made one mark at the midpoint between them. After the measurement, a Magnetic Resonance of the thighs is made.

    Measured: one day before surgery

Secondary outcomes (6)

  1. Thighs circumference measurement

    Thigh circumference measurements made with anthropometric metal tape and a Permanent Marker, based in bone parameters in supine position. Using as reference the bony protuberance of the trochanter, the first mesurement will be taken 5 (five) cm below this point and 5 (five) cm above the patella, and betwin this two points will be made one mark at the midpoint between them

    Measured: 7th postoperative day

  2. Thighs circumference measurement

    Thigh circumference measurements made with anthropometric metal tape and a Permanent Marker, based in bone parameters in supine position. Using as reference the bony protuberance of the trochanter, the first mesurement will be taken 5 (five) cm below this point and 5 (five) cm above the patella, and betwin this two points will be made one mark at the midpoint between them

    Measured: 9th postoperative day

  3. Thighs circumference measurement

    Thigh circumference measurements made with anthropometric metal tape and a Permanent Marker, based in bone parameters in supine position. Using as reference the bony protuberance of the trochanter, the first mesurement will be taken 5 (five) cm below this point and 5 (five) cm above the patella, and betwin this two points will be made one mark at the midpoint between them. After the measurement, a Magnetic Resonance of the thighs is made.

    Measured: 14th postoperative day

  4. Thighs circumference measurement

    Thigh circumference measurements made with anthropometric metal tape and a Permanent Marker, based in bone parameters in supine position. Using as reference the bony protuberance of the trochanter, the first mesurement will be taken 5 (five) cm below this point and 5 (five) cm above the patella, and betwin this two points will be made one mark at the midpoint between them.

    Measured: 16th postoperative day

  5. Thighs circumference measurement

    Thigh circumference measurements made with anthropometric metal tape and a Permanent Marker, based in bone parameters in supine position. Using as reference the bony protuberance of the trochanter, the first mesurement will be taken 5 (five) cm below this point and 5 (five) cm above the patella, and betwin this two points will be made one mark at the midpoint between them.

    Measured: 21th postoperative day

  6. Thighs circumference measurement

    Thigh circumference measurements made with anthropometric metal tape and a Permanent Marker, based in bone parameters in supine position. Using as reference the bony protuberance of the trochanter, the first mesurement will be taken 5 (five) cm below this point and 5 (five) cm above the patella, and betwin this two points will be made one mark at the midpoint between them. After the measurement, a Magnetic Resonance of the thighs is made.

    Measured: 28th postoperative day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionNov 2012
  4. Study completionNov 2013 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01470378
Sponsor's protocol ID
UNIFESP_LILIA
Acronym
Thight_lift
Status last verified
Aug 2013
First submitted
2 Nov 2011
Last updated
9 Aug 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Le Louarn C, Pascal JF. The concentric medial thigh lift. Aesthetic Plast Surg. 2004 Jan-Feb;28(1):20-3. doi: 10.1007/s00266-003-3095-x. Epub 2004 Mar 25.

    PubMed 15037958

  • Nemerofsky RB, Oliak DA, Capella JF. Body lift: an account of 200 consecutive cases in the massive weight loss patient. Plast Reconstr Surg. 2006 Feb;117(2):414-30. doi: 10.1097/01.prs.0000197524.18233.bb.

    PubMed 16462321

  • 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.

    PubMed 12140705

  • Moreno CH, Neto HJ, Junior AH, Malheiros CA. Thighplasty after bariatric surgery: evaluation of lymphatic drainage in lower extremities. Obes Surg. 2008 Sep;18(9):1160-4. doi: 10.1007/s11695-007-9400-z. Epub 2008 Jun 11.

    PubMed 18546051

  • Kolker AR, Xipoleas GD. The circumferential thigh lift and vertical extension circumferential thigh lift: maximizing aesthetics and safety in lower extremity contouring. Ann Plast Surg. 2011 May;66(5):452-6. doi: 10.1097/SAP.0b013e3182145682.

    PubMed 21451373

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Thigh Surgery in people with Lymphedema and Obesity, run by Federal University of São Paulo at 1 site in Brazil.

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 5 inclusion and 7 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 9 Aug 2013. 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 Brazil. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preoperative measurement. (time frame: one day before surgery). 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 NCT01470378, which also lists 5 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 9 Aug 2013; AzTrials last refreshed its copy on 7 Nov 2026.

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