Study of Scarpa´s Fascia in the Formation of Seroma Post Abdominoplasty After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Total Volume of Drainage in ml.
研究概览
简要总结
46 female postbariatric patients will be submitted to anchor-line abdominoplasty with drains insertion. Patients will be randomized to two groups. One group will have the Fascia Scarpa removed and in the other the Fascia Scarpa will be preserved. The drains will be removed when the volume is less than 30 ml in 24 hours. The primary outcome will be the volume of total drainage obtained in the drains of the abdominal region. Secondary outcomes will be the length of time the drains remain and the presence of seroma assessed by ultrasound on the twentieth postoperative day.
详细描述
Morbid obesity has been increasing in Brazil and the world and bariatric surgery is the most effective and long-lasting treatment. This leads to large weight losses leading to large body deformities due to excess skin and subcutaneous tissue. The most common post-bariatric plastic surgery is post-bariatric abdominoplasty which main complication is seroma. PURPOSE: To evaluate the effect of Scarpa fascia preservation in seroma reduction. METHODS: A total of 46 patients were randomly assigned to two groups. One group will have the Fascia Scarpa removed and in the other the Fascia Scarpa will be preserved. The drains will be removed when the volume is less than 30 ml in 24 hours. The primary outcome will be the volume of total drainage obtained in the drains of the abdominal region. Secondary outcomes will be the length of time the drains remain and the presence of seroma assessed by ultrasound on the twentieth postoperative day.
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
- Single (Participant)
盲法说明
The patient will not know if the Scarpa´s fascia has been removed or preserved.
入排标准
- 年龄范围
- 24 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BMI between 22 and 30 Kg/m2
- •Female post-bariatric patient
排除标准
- •neoplasms
- •lymphatic system diseases
- •abdominal scars except C section and bariatric surgery scars
- •mental disorders
研究组 & 干预措施
Abdominoplasty without Scarpa´s Facia
Anchor-line abdominoplasty where the Scarpa's Fascia will be removed.
干预措施: Abdominoplasty without Scarpa´s Facia (Procedure)
abdominoplasty with Scarpa's Fascia
Anchor-line abdominoplasty where the Scarpa's Fascia will be preserved.
干预措施: abdominoplasty with Scarpa's Fascia (Procedure)
结局指标
主要结局
Total Volume of Drainage in ml.
时间窗: number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days
We will measure the total volume of drainage, in ml, obtained by the drains in the abdominal region. The measure of drainage will be done at the same time (8:00 am) and by the same nurse everyday in all patients until the drain is withdrawn. The drain will be withdrawn when the drained volume is less than 30 ml in 24 hours. Total volume of drainage will be calculated as the sum of the volumes obtained daily.
次要结局
- Number of Days Required for Drain Withdrawal.(Number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days)
- Volume of Seroma Assessed by Ultrasound of the Abdominal Wall.(Done after 20 days of surgery)
研究者
Heraldo Carlos Borges
M D - Professor
Federal University of São Paulo