A Prospective Randomized Controlled Trial Comparing Billroth-I Reconstruction With Roux-en Y Reconstruction After Distal Gastrectomy for Gastric Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- the postoperative quality of life (QOL)
研究概览
简要总结
The purpose of this study is to evaluate the quality of life (QOL) after Billroth-I reconstruction (B-I) following distal gastrectomy, compared with Roux-en Y reconstruction (R-Y) in patients with gastric cancer.
详细描述
The purpose of this study is to evaluate the quality of life (QOL) after Billroth-I reconstruction (B-I) following distal gastrectomy, compared with Roux-en Y reconstruction (R-Y) in patients with gastric cancer. There is no prospective randomized study of the two operative procedures focusing on postoperative QOL. The investigators conducted a prospective randomized trial on 120 patients who underwent distal gastrectomy comparing Billroth-I reconstruction and Roux-en Y reconstruction.
The primary endpoint was the postoperative QOL. The secondary endpoints were the incidence of postoperative complications, nutritional status, and the incidence of the remnant gastritis and the reflux esophagitis. Patients were recruited into this study before surgery, on the basis of whether distal gastrectomy was anticipated at Wakayama Medical University Hospital(WMUH) for gastric cancer, and appropriate informed consent was obtained. Exclusion criteria was 1) patients with severe complications which were possible to prolong hospital stay, 2) patients with history of other organ malignancies, 3) patients who were diagnosed inadequacy for this study by a physician, and 4) patients without an informed consent.
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
- 年龄范围
- 20 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of stomach
- •Performance status: Eastern Cooperative Oncology Group (ECOG) 0-1
- •Tumor located in the antrum or the angle or the lower body of stomach
- •Appropriate informed consent was obtained.
排除标准
- •Patients with severe complications which were possible to prolong hospital stay
- •Patients with history of other organ malignancies
- •Patients who were diagnosed inadequacy for this study by a physician
- •Patients without an informed consent
研究组 & 干预措施
Roux-en Y
Roux-en Y reconstruction after distal gastrectomy
干预措施: Roux-en Y reconstruction (Procedure)
Billroth-I
Billroth-I reconstruction after distal gastrectomy
干预措施: Billroth-I reconstruction (Procedure)
结局指标
主要结局
the postoperative quality of life (QOL)
时间窗: 3 years after operation
次要结局
- the incidence of postoperative complications, nutritional status, and the incidence of the remnant gastritis and the reflux esophagitis(1, 3 and 5 years after operation)
研究者
Hiroki Yamaue
Second Department of Surgery, Wakayama Medical University
Wakayama Medical University
