Manual Lymphatic Drainage in Women Undergone to Thigh Lifting (Thight_lift)

Federal University of São Paulo

Status and phase: Unknown; Phase 1

Conditions: Lymphedema; Obesity

Treatments: Procedure: Thigh Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01470378

UNIFESP_LILIA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Control Group

Active Comparator group

Description:

This group will not be undergoing to manual lymphatic drainage

Treatment:

Procedure: Thigh Surgery

Study Group

Active Comparator group

Description:

This group will be undergoing to manual lymphatic drainage

Treatment:

Procedure: Thigh Surgery