Outcomes of Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- the incidence of postoperative stable line bleeding
研究概览
简要总结
three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into equal two groups, group A : will operated by standard sleeve gastrectomy on bougie 36 without plication of stable line and group B: will operated by sleeve gastrectomy on bougie 42 with plication of stable line. the aim is to test the effect of pilcation on the incidence of leaks and bleeding
详细描述
three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into equal two groups, group A : will operated by standard sleeve gastrectomy on bougie 36 without plication of stable line and group B: will operated by sleeve gastrectomy on bougie 42 with plication of stable line. the primary outcomes is the incidence of leaks and bleeding which is the main nightmare of sleeve gastrectomy, secondary outcome operative time, weight loss and metabolic effect
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
- Triple (Participant, Care Provider, 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
the incidence of postoperative stable line bleeding
时间窗: 2-24 hours
early postoperative bleeding from stable line
the incidence of stable line leakage
时间窗: 1-30 days
leak from stable line
次要结局
未报告次要终点
研究者
Alaa Mstafa Hassan Sewefy
Assistant professor and consultant of general surgery
Minia University