Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis After Bariatric Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 主要终点
- Satisfaction degree. 7-points Likert scale was used for the quantification.
研究概览
简要总结
A prospective randomized clinical trial of patients undergoing bariatric surgery.
Patients were randomly assigned into 3 groups: those patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training (Group 1), those patients doing the specific training alone (Group 2) and those patients without any specific treatment (Group 3).
The assigned treatment began 15 days after surgery and was maintained during 12 weeks.
详细描述
A prospective randomized clinical trial of patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (RYGB) during 2014 was performed.
Patients were randomly assigned using a random-number table into 3 groups: those patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training (Group 1), those patients doing the specific training alone (Group 2) and those patients without any specific treatment (Group 3).
The assigned treatment began 15 days after surgery and was maintained during 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with body mass index (BMI) >40 Kg/m2 or BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity, undergoing a bariatric procedure.
排除标准
- •all kind of previous breast surgery.
研究组 & 干预措施
PENS with training
Patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training during 12 weeks postoperatively
干预措施: PENS (Device)
PENS with training
Patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training during 12 weeks postoperatively
干预措施: Specific training (Other)
Specific training
Patients undergoing specific training during 12 weeks postoperatively
干预措施: Specific training (Other)
No intervention
No specific treatment was assigned to these patients postoperatively
结局指标
主要结局
Satisfaction degree. 7-points Likert scale was used for the quantification.
时间窗: 12 weeks of treatment
The patients were asked to quantify their satisfaction degree with the esthetic results of their breasts after the treatment.
次要结局
未报告次要终点
研究者
Jaime Ruiz-Tovar, MD, PhD
MD, PhD
Hospital General Universitario Elche