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临床试验/NCT02347956
NCT02347956已完成1 期

The Safety and Feasibility of Reduced Port Robotic Distal Gastrectomy Using Single-site for Surgical Treatment of Early Gastric Cancer

Yonsei University2 个研究点 分布在 2 个国家目标入组 19 人开始时间: 2015年1月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
19
试验地点
2
主要终点
morbidity

研究概览

简要总结

Gastric cancer is one of the most common malignancy worldwide. Surgical resection of the tumor is the only curative treatment for gastric cancer. However, surgical procedure accompanies postoperative pain and prolonged hospitalization. To lessen the surgical trauma and stress, minimally invasive surgery were introduced. Laparoscopic gastrectomy was accepted as safe and effective alternative to open gastrectomy. Furthermore, reduced port and single port laparoscopic gastrectomy are considered to minimize the surgical trauma during gastrectomy. However, limitations of laparoscopic approach using reduced port includes unergonomic posture of surgeon, physiologic tremor and collision of instruments. To overcome these limitations, robot surgery using novel single-site technology enabled surgeons to perform the surgical procedure reducing the number of trocar from three to one for insertion of scope and two robotic arms. Previously, successful application of single-site technology for cholecystectomy and hysterectomy were reported. The aim of this study is to validate the safety and feasibility of reduced port robotic distal gastrectomy using single-site technology for the surgical treatment of gastric cancer.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A resectable, tissue confirmed adenocarcinoma of the stomach
  • Early gastric cancer curable by distal gastrectomy
  • ASA score 1-3
  • A patient who signed the informed consent

排除标准

  • Advanced lesion with metastatic cancer
  • lesion which is curable by EMR or ESD
  • Previous major abdominal surgery
  • Complicated gastric cancer (obstruction or perforation)
  • History with other primary tumor within 5 year
  • Active other primary tumor
  • Vulnerable subjects (pregnant women, illiterate)

研究组 & 干预措施

Reduced port group

Experimental

干预措施: Reduced port robotic distal gastrectomy (Procedure)

结局指标

主要结局

morbidity

时间窗: 30 days

次要结局

  • mortality(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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