Clinical trial NCT01470378: Manual Lymphatic Drainage in Women Undergone to Thigh Lifting
Official title: Manual Lymphatic Drainage in Women Undergone to Thigh Lifting After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Lymphedema
Obesity
Keywords: Lymphedema
Magnetic Resonance Imaging
Plastic Surgery
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2011-11-11
Enrollment: 20
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Preoperative measurement.
timeFrame: one day before surgery
Secondary outcomes:
measure: Thighs circumference measurement
timeFrame: 7th postoperative day
measure: Thighs circumference measurement
timeFrame: 9th postoperative day
measure: Thighs circumference measurement
timeFrame: 14th postoperative day
measure: Thighs circumference measurement
timeFrame: 16th postoperative day
measure: Thighs circumference measurement
timeFrame: 21th postoperative day
measure: Thighs circumference measurement
timeFrame: 28th postoperative day
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Lydia M Ferreira, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.