NCT04037670已完成不适用
Assessment of the Efficacy of SASI Bypass in Super Obese Patients With BMI> 50 Kg/m2
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- percentage of excess weight loss
研究概览
简要总结
Although previous studies investigated weight loss and improvement in comorbidities after SASI bypass, patients included in these studies had a BMI less than 50 Kg/m2. Therefore, the aim of the present study was to investigate the outcome of SASI bypass in patients with super obesity to assess the success of this novel bariatric procedure in this challenging group of patients in regards weight loss and improvement in associated comorbid conditions at 12 months postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients included to the present study were adult patients of both genders aging between 18 and 65 years with primary morbid obesity with BMI ≥50 kg/m2 with or without obesity-associated comorbidities such as hypertension, diabetes mellitus (DM), dyslipidemias, and gastroesophageal reflux disease (GERD).
排除标准
- •Pregnant women.
- •Patients unfit for general anasthesia (ASA 4, 5)
- •Endocrine or psychiatric disorders.
- •History of previous upper abdmominal laparotomy.
- •Alcoholic addiction
- •Liver cirrhosis
- •Coagulopathy
研究组 & 干预措施
SASI bypass
Experimental
Patients with super obesity underwent SASI bypass
干预措施: SASI bypass (Procedure)
结局指标
主要结局
percentage of excess weight loss
时间窗: at 12 months of follow-up
\[preoperative weight - weight at 12 months\]/preoperative excess weight X 100
次要结局
- Resolution of diabetes mellitus(at 12 months of follow-up)
研究者
Sameh Emile
Lecturer of surgery
Mansoura University
研究点 (2)
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