Efifcacy and Safety of Anastomotic Leak Testing in Gastric Cancer: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Anastomotic leakage
研究概览
简要总结
Anastomotic leak after radical gastrectomy is a serious complication. Intraoperative leak testing was often used to assess the integrity of the anastomosis. However, the reliability, clinical benefits and safety of intraoperative leak testing are controversial. Our aim is to evaluate the effect and safety of intraoperative leak testing, and to compare the surgical complications of patients in intraoperative leak testing group with patients in non-intraoperative leak testing group.
详细描述
Anastomotic leak after radical gastrectomy is a serious complication. Intraoperative leak testing was often used to assess the integrity of the anastomosis. However, the reliability, clinical benefits and safety of intraoperative leak testing are controversial. Our aim is to evaluate the effect and safety of intraoperative leak testing, and to compare the surgical complications of patients in intraoperative leak testing group with patients in non-intraoperative leak testing group. patients underwent total gastrectomy for gastric cancer, with esophagojejunostomy reconstruction.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •resectable gastric carcinoma according to the eighth edition of the TNM (clinical stages I-III).
- •Eastern Cooperative Oncology Group performance status of 0 or
- •American Society of Anesthesiologists class of I-III.
排除标准
- •Patients had distant metastasis.
- •presence of obvious contraindications to surgery (e.g., liver and/or kidney function abnormalities).
- •any participation in another clinical trial within the past 6 months.
- •Previous chemotherapy or radiation therapy for any other malignancies.
- •past history of gastric resection, gastric cancer-related complications, other malignancy diagnosed within the previous 5 years,
结局指标
主要结局
Anastomotic leakage
时间窗: 2 months
all patients underwent upper gastrointestinal radiography after surgery for detecting the integrity of anastomosis. X-ray to detect the integrity of the anastomosis
次要结局
- Postoperative surgical complications(3 months)
研究者
Yunhong Tian
Professor
Nanchong Central Hospital