Manual Lymphatic Drainage in Women Undergone to Thigh Lifting

Phase 1

• Conditions: Lymphedema; Obesity
• Interventions: Procedure: Thigh Surgery

• Registration Number: NCT01470378
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-11-02
• Study First Submitted QC: 2011-11-10
• Study First Posted: 2011-11-11
• Primary Completion: 2012-11
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-07
• Last Update Posted: 2013-08-09
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Thigh Surgery	This group will not be undergoing to manual lymphatic drainage
Study Group	Thigh Surgery	This group will be undergoing to manual lymphatic drainage

Primary Outcome Measures

Name	Time	Method
Preoperative measurement.	one day before surgery	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.

Secondary Outcome Measures

Name	Time	Method
Thighs circumference measurement	28th postoperative day	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.

Trial Locations

Locations (1)

Federal University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil