Phase III Study of Hybrid-everted Versus Hand-sewn of Stapled Esophagogastrostomy in Prevention of Anastomotic Stricture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 主要终点
- the incidence of anastomotic stricture
研究概览
简要总结
The investigators improved the hybrid everted esophagogastrostomy and expected to prevent the incidence of anastomotic stricture. The purpose of this study is to determine the clinical value of this kind of operation type, and analyzes the clinicopathological factors causing the postoperative complications.
详细描述
This randomized clinical trial compared a hybrid everted esophagogastric anastomosis with conventional hand-sewn or stapled esophagogastrostomy for prevention of anastomotic stricture. The patients were completely randomized to receive either a hybrid everted esophagogastric anastomosis (HE group), or the conventional hand-sewn (HS group), or a stapled (SA group) anastomosis, after the removal of esophageal tumor. The primary outcome measured the incidence of anastomotic stricture at 3 months after the operation (defined as the diameter of the anastomotic orifice <= 0.8 cm on esophagogram), analyzed by intention-to-treat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologically diagnosed esophageal neoplasms
- •undergoing the Esophagogastrostomy
排除标准
- •the patients with previous the upper gastrointestinal tract surgery
- •the esophageal carcinoma patients with previous neoadjuvant chemotherapy
- •the esophageal carcinoma complicated other esophagogastric diseases
结局指标
主要结局
the incidence of anastomotic stricture
时间窗: three months
the anastomotic stricture is defined as the diameter of the anastomotic orifice \<= 0.8 cm on esophagogram
次要结局
- The grades of dysphagia(three months)
- the grades of acid regurgitation(three months)
- the clinicopathological parameters in relation to postoperative complications(three months)