Study on the Difference of Anastomotic Leakage Ratio Between Wide and Narrow Gastric Conduit During Minimally Invasive Esophagectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The anastomotic leakage rate
研究概览
简要总结
The study hypothesized that a narrow gastric conduit(less than 3cm in width) would minimize anastomotic leakage following minimally invasive esophagectomy. Therefore we raise this random-controlled research, and investigate the leakage ratio from different widths of gastric conduit formed during the operation.
详细描述
Patients underwent minimally invasive esophagectomy in Zhongshan Hospital of Fudan University will be enrolled and be assigned to wide or narrow gastric conduit group randomly. Intra-operative blood supply and vascular SaO2 will be observed during the operation, and the rate of anastomotic leakage, together with its clinical details will be recorded in the two groups.
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
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients underwent minimally invasive esophagectomy(three-hole procedure)
- •Clinical Staged T1-3N0M0 esophageal cancer patients or: patients who were restaged as T1-3N0M0 esophageal cancer after neo-adjuvant therapy
排除标准
- •With previous cancer history
- •Severe Co-morbidity
结局指标
主要结局
The anastomotic leakage rate
时间窗: the anastomotic leakage of participants will be followed for the duration of hospital stay, an expected average of 2 weeks
The anastomotic leakage is a severe complication following minimally invasive esophagectomy. The definition of anastomotic leakage is determined as per the STS (SOCIETY OF THORACIC SURGEONS) database.
次要结局
未报告次要终点
研究者
Tan, Lijie
Associate Professor of Surgery; Vice Chief, Division of Thoracic Surgery
Fudan University