The Correlation of Oral Anti-Infective Agent With Anastomotic Leakage in Reconstruction Surgery for Esophageal Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- all cause anastomotic leakage
研究概览
简要总结
Anastomotic leakage is still to be a major cause of considerable morbidity and mortality after esophagectomy and gastric pull up for esophageal carcinoma. Risk factor analyses of anastomotic leakage, including blood supply, graft tension, and comorbidity, have been performed, but few studies have produced strategies that have improved operative results. This study will be performed to identify prognostic variables that might be used to develop a strategy for optimizing outcomes after esophagogastrectomy.
详细描述
Goal:
The effect of oral hygiene on the occurrence of esophagogastric anastomotic leakage has not yet been studied for along time. We will use a random cohort study model and investigate the effect of perioperative oral anti-infective gargle agent on the esophagogastric anastomotic wound healing.
Method:
- Design:
One hundred and twenty patients are divided into 3 groups and each group has 40 esophageal patients. Minimization stratified randomization will be applied. Oral anti-infective gargling agent, Mycostatin oral suspension, will be employed for one week before operation. The first groups will be treated without oral gargle agent; the second groups will be treated with gargling water; and the third groups will be treated with anti-infective gargling agent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •carcinoma of the esophagus, operable stage I to III
排除标准
- •patients who were inoperable,
- •patients who had obvious impaired blood supply of gastric substitutes, and
- •patients who had non-cervical esophagogastrostomy.
研究组 & 干预措施
2
perioperative gargling with water
干预措施: Water (Other)
3
perioperative oral gargling with oral anti-infective agent for seven days
干预措施: Mycostatin oral suspension (Drug)
结局指标
主要结局
all cause anastomotic leakage
时间窗: two years
次要结局
- Time variation of starting oral feeding and hospital stay(two years)