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临床试验/NCT01065688
NCT01065688已完成3 期

A Prospective Randomized Controlled Trial Comparing Billroth-I Reconstruction With Roux-en Y Reconstruction After Distal Gastrectomy for Gastric Cancer

Wakayama Medical University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2009年1月最近更新:
适应症
干预措施

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

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

Active Comparator

Roux-en Y reconstruction after distal gastrectomy

干预措施: Roux-en Y reconstruction (Procedure)

Billroth-I

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hiroki Yamaue

Second Department of Surgery, Wakayama Medical University

Wakayama Medical University

研究点 (2)

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