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临床试验/NCT05051670
NCT05051670已完成不适用

The Safety and Feasibility of Reduced Port Robotic Distal Gastrectomy Using da Vinci SP for Early Gastric Cancer

Yonsei University1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2021年12月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
major complication

研究概览

简要总结

Laparoscopic surgery revolutionized the surgical treatment of gastric cancer saving large incsion and associated pain. Robotic surgical system was introduced to enhance the minimally invasive surgery using articulating robotic arm. The da vinci SP system, which enables single-port surgery, can allow surgeon to provide radical gastrectomy with minimal scar and associated pain.

详细描述

This study is a phase 1/2, single-arm surgical clinical trial. The primary endpoint is the safety of da vinci robotic gastrectomy. The secondary endpoint is operative time, bleeding, bowel recovery, and hospital stay. In the clinic, informed consent is received from patient who is scheduled to undergo radical gastrectomy. After the general anesthesia, low midline transverse incision is made at suprapubic area. After inserting SP port into the peritoneal cavity, additional port is inserted via right flank that would be used for assistant's energy device and suction devices. Radical subtotal gastrectomy is perfromed using cardiere-forceps, monopolar scissors, and maryland forceps. Reconstruction after gastrectomy is decided according to surgeon's preference. three days after gastrectomy, if the diet build up is complete and the patients has no evidence of complication, the patient is discharged from the hospital. Four weeks after gastrectomy, the patient will be followed up at the clinic. Major complication event within 30days after gastrectomy will be analyzed as primary endpoint as well as other secondary endpoints.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Biopsy confirmed adenocarcinoma of stomach scheduled to undergo radical gastrectomy
  • Between 20-80
  • ASA score (American society of anesthesiology) class: I - III
  • Signed to informed consent after through explanation about the study

排除标准

  • distant metastasis
  • EMR/ESD canddiate
  • complicated gastric cancer (obstruction or perforation)
  • Active other primary tumor
  • Vulerable subject (illiterate, pregnant)

结局指标

主要结局

major complication

时间窗: 30 days after gastrectomy

Clavien-Dindo classification grade 3 or more

次要结局

  • Operation time(30 days after gastrectomy)
  • bleeding(30 days after gastrectomy)
  • bowel recovery(30 days after gastrectomy)
  • Hospital stay(30 days after gastrectomy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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