NCT05591833已完成不适用
Single Anastomosis Sleeve Ileal Bypass Versus Single Anastomosis Sleeve Jejunal as a Treatment of Morbid Obesity
Minia University2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2022年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- nutritional deficiency
研究概览
简要总结
to compare the results of SASI to SAS-J in treatment of morbid obesity
详细描述
200 of patients indicated for obesity surgery will be divided into 2 groups : Group 1, will be operated by SASI and Group 2, will be operated by SAS-J
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
- •patients fit for laparoscopic surgery
- •give approval to share in the study
排除标准
- •patients refused to share in the study
- •patients unfit for surgery
- •patients aged less than 18 and older than 60
- •patient with previous upper abdominal surgery either for obesity or other diseases
- •revisional bariatric procedures
结局指标
主要结局
nutritional deficiency
时间窗: 12 months
the effect of the 2 procedures on nutritional status by doing the following investigations to collectively give idea about deficiency this investigation including: Hb% ( in mg/dL), vitamin D (in ng/mL) , vitamin B ( in pg/mL), Serum Ca (in mg/dL) serum Zinc (in μg/dL) serum Iron ( in mcg/dL) serum Folate (in μg/L) and serum albumin ( in g/dL)
次要结局
- comorbidities(1 year)
- complications(1 year)
- weight loss(12 months)
研究者
Alaa Mstafa Hassan Sewefy
Assistant Professor & Consultant of General Surgery and laparo-endoscopy
Minia University
研究点 (2)
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