A Prospective Trial to Evaluate Whether Variations in Tissue Oxygenation Are Associated With Anastomotic Leak Rates After an Ivor Lewis Esophagectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- association between tissue oxygenation (measured using the Wipox) at the anastomotic site and the incidence of anastomotic leak after an Ivor Lewis esophagectomy.
研究概览
简要总结
The purpose of this study is to test whether after an Ivor Lewis esophagectomy (the removal of a portion of the stomach and esophagus with re-attachment) there is an association between the intraoperative level of oxygen at the site where the esophagus is re-attached to the stomach (measured using the Wipox), and the incidence of a disruption at the site of the attachment after the surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are scheduled to undergo an open or a minimally invasive Ivor Lewis esophagectomy
- •> or = to 21 years of age
排除标准
- •Patients who are not candidates for an esophagectomy as determined by the treating surgeon
结局指标
主要结局
association between tissue oxygenation (measured using the Wipox) at the anastomotic site and the incidence of anastomotic leak after an Ivor Lewis esophagectomy.
时间窗: 2 years
The primary objective of this observational study is to determine whether in patients undergoing Ivor Lewis esophagectomy, low levels of tissue oxygenation at the anastomotic site are associated with increased risk of anastomotic leak (AL).
次要结局
- To correlate various demographic(2 years)
- To correlate anastomotic site tissue oxygenation with the postdischarge incidence of stricture(2 years)
- To correlate clinical variables(2 years)