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Status unknownNCT01470378Thight_liftUpdated Aug 9, 2013

Manual Lymphatic Drainage in Women Undergone to Thigh Lifting

A Phase 1 interventional study of Thigh Surgery in Lymphedema and Obesity, sponsored by Federal University of São Paulo. Status unknown at 1 site in Brazil. Open to female participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-09.

Sponsored by Federal University of São Paulo · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Lymphedema
  • Obesity

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Keywords

  • Lymphedema
  • Magnetic Resonance Imaging
  • Plastic Surgery
03

In context

Lymphedema

560 studies on the registry are indexed under Lymphedema; 135 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 403 interventional studies indexed under Lymphedema.

Browse Lymphedema studies →

Lead sponsor

Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Control Group

    This group will not be undergoing to manual lymphatic drainage

    Procedure: Thigh Surgery

  • Active comparator
    Study Group

    This group will be undergoing to manual lymphatic drainage

    Procedure: Thigh Surgery

Interventions

  • ProcedureThigh Surgery

    Circumferential thigh surgery post bariatric surgery

    Also known as: Thigh plastic surgery, Postobesity surgery

06

What researchers measure

Primary outcomes

  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.

    Time frame: one day before surgery

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 28th postoperative day

07

Study locations

1 of 1 sites recruiting
  • Federal University of Sao Paulo
    Sao Paulo, 04023-900, Brazil
    • Elvio B Garcia, MD · Contact · elvio@uol.com.br · 551155739525
    • Lilia C Arruda, PhD · Contact · 551150965996
    • Lilia C Arruda, PhD · Principal investigator
    Recruiting
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01470378
Lead sponsor
Federal University of São Paulo
Responsible party
Lilia Cristina de Arruda (Principal Investigator, Federal University of São Paulo) — Principal investigator
First posted
Nov 11, 2011
Start date
Jan 2011
Primary completion
Nov 2012
Completion
Nov 2013 (estimated)
Last update
Aug 9, 2013

Study contacts

Lydia M Ferreira, MD
study chair · Federal University of São Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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