Manual Lymphatic Drainage in Women Undergone to Thigh Lifting After Bariatric Surgery
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Preoperative measurement.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Preoperative measurement.
时间窗: 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.
次要结局
- Thighs circumference measurement(28th postoperative day)
研究者
Lilia Cristina de Arruda
Principal Investigator
Federal University of São Paulo