Single-port Robot-assisted Surgery for Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The rate of intraoperative complications
研究概览
简要总结
This clinical study was a prospective, single-center, single-arm exploratory study. Subjects who meet the inclusion criteria will be enrolled in this study, where surgeons will perform single-port robot-assisted gastrectomy, and explore and evaluate the safety and efficacy of this clinical application.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old and age ≤80 years old, regardless of gender;
- •patients who met the surgical indications and were confirmed by the investigator to be in need of laparoscopic surgery.
- •patients with American Society of Anesthesiologists (ASA) physical status classification ⅰ-ⅲ.
- •Be able to cooperate with the completion of visits and related examinations specified in the protocol.
- •Subjects voluntarily participated in the clinical trial and agreed or their guardians agreed to sign an informed consent.
排除标准
- •patients with severe heart, lung, brain, liver, or kidney diseases can not tolerate surgery or anesthesia;
- •those who cannot tolerate pneumoperitoneum;
- •patients with serious systemic diseases that are not suitable for surgical treatment according to the judgment of the investigator;
- •patients with a history of severe bleeding disease, hematopoietic dysfunction or coagulation dysfunction, who are not suitable for surgical treatment according to the judgment of the investigator, and long-term use of anticoagulant and antiplatelet drugs (antiplatelet aggregation drugs were discontinued less than 1 week before surgery);
- •patients with active pulmonary tuberculosis;
- •HIV antibody positive; Hepatitis B surface antigen (HbsAg) positive and hepatitis B virus DNA (HBV-DNA) copy number higher than the detection limit or normal range; Hepatitis C virus (HCV) antibody positive; Patients with positive treponema pallidum antibody and high risk of infection judged by the researcher;
- •with epilepsy, psychiatric history or cognitive impairment;
- •pregnant and lactating women;
- •Extensive and severe adhesion in the abdominal cavity caused the inability to perform puncture to establish pneumoperitoneum, and it was difficult to isolate and expose the lesion; A history of major abdominal surgery and abdominal radiotherapy were included, according to the investigator's judgment Situations where there is a risk of extensive adhesion;
- •participants who participated in other interventional clinical trials within 3 months before screening;
- •other circumstances that the investigator deemed inappropriate to participate in the trial.
研究组 & 干预措施
Single-port robot-assisted gastrectomy
SHURUI Endoscopic Surgical Robotic System (SR-ENS-600)
干预措施: SHURUI Endoscopic Surgical Robotic System (SR-ENS-600) (Device)
结局指标
主要结局
The rate of intraoperative complications
时间窗: The day of surgery
Intraoperative complications, including organ injury and vascular injury, were evaluated
The rate of postoperative complications
时间窗: Postoperative 30 days
Postoperative complications, including postoperative bleeding, fever, and incisional infection, were evaluated using the Clavien-Dindo grading system to determine whether the occurrence of complications was related to the study instrument or surgery.
次要结局
未报告次要终点
研究者
Qun Zhao
Hebei Medical University
Hebei Medical University