A Superiority Study for Postoperative Reflux After Distal Gastrectomy With Antiperistaltic vs Isoperistaltic Billroth II + Braun Anastomosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 214
- 主要终点
- Postoperative Reflux Rate
研究概览
简要总结
Postoperative gastroesophageal reflux is one of the most common complications of distal gastrectomy. With more attention paid on it by surgeons, several new operation methods have been practised. Among all these, distal gastrctomy with Billroth II + Braun anastomosis was reported to be an useful method to decrease postoperative reflux rate. Meanwhile, the direction of anastomotic peristalsis has also been reported to affect the anastomosis and thus make difference in reflux rate. We design this study to investigate the potential effect and the superiority of antiperistaltic vs isoperistaltic Billroth II + Braun reconstruction in distal gastrectomy.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically diagnosed as gastric cancer before surgery
- •Clinical staging: cT1-4aN0-3M0
- •Postoperative evaluation concluded B-II B anastomosis
- •Consent assigned
排除标准
- •Diagnosed with other malignancies within 2 years
- •Gastric cancer with clinical staging: cT4b or M1
- •Women with pregnancy or breast-feeding
- •Emergency procedures
- •Consent not assigned
研究组 & 干预措施
Antiperistaltic
In this group patients undergo the distal gestrectomy with antiperistaltic Billroth II + Braun anastomosis
干预措施: Antiperistaltic Billroth II + Braun anastomosis (Procedure)
Isoperistaltic
In this group patients undergo the distal gestrectomy with isoperistaltic Billroth II + Braun anastomosis
干预措施: Isoperistaltic Billroth II + Braun anastomosis (Procedure)
结局指标
主要结局
Postoperative Reflux Rate
时间窗: 1 yrs
The rate of bile reflux within 1yrs postoperation
次要结局
- Disease-free survival(3yrs)
- Surgery-related reflux gastritis rate(1yrs)
- Surgery-related reflux esophagitis rate(1 yrs)
- Overall survival(3 yrs)