Routine Preoperative PPI in Sleeve Gastrectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- early postoperative bleeding and leak
研究概览
简要总结
he purpose of this study is to study the effect of preoperative PPI in the early outcome of sleeve gastrectomy
详细描述
In this study 200 morbidly obese patients will be included and will be undergone sleeve gastrectomy. the patients will be randomly assigned into 2 groups, group 1 will be receive PPI preoperative for 10 day and group 2 will not
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Morbidly obese patient with BMI more than 40 with or without co-morbidity
- •Morbidly obese patient with BMI more than 35 with co-morbidity
排除标准
- •Unfit patients for laparoscopic sleeve gastrectomy
- •patients refuse to share in the study
- •patients that already on PPI due to any indications
- •revisional surgery for obesity
- •previous upper abdominal surgery
研究组 & 干预措施
PPI group
take preoperative PPI for 10 days
干预措施: sleeve + preoperative PPI (Combination Product)
Control group
take placebo for for 10 days preoperative
干预措施: sleeve + preoperative Placebo (Combination Product)
结局指标
主要结局
early postoperative bleeding and leak
时间窗: 2 weeks
early postoperative complications, including bleeding from stable line either intragastric or intraperitoneal and early leak from stable line
次要结局
- operative time(5 hours)
- microscopic picture of the removed stomach(2 weeks)
研究者
Alaa Mstafa Hassan Sewefy
Principal Investigator
Minia University