NCT04843189Unknown不适用
Prospective Registration Study of Robtic Laparoscopy Versus Laparoscopy Assisted Colon Cancer Surgery
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 648
- 试验地点
- 1
- 主要终点
- Number of lymph nodes harvested
研究概览
简要总结
The purpose of this study is to compare the clinical data of patients with colon cancer who received robotic or laparoscopic surgery, and to compare the short-term and long-term effects of robotic surgery in the treatment of colon cancer. To verify the safety and effectiveness of the corresponding surgical methods, and provide better guidance for the following clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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: 18-80 years old, male or female;
- •Colon cancer (ascending colon, transverse colon, descending colon, sigmoid colon) is diagnosed by histology or cytology;
- •The clinical stage is T1-4aN0-2M0; 4 No multiple distant metastases;
- •ECOG score 0-2;
- •Heart, lung, liver, and kidney functions can tolerate surgery;
- •Patients and their families can understand and are willing to participate in this clinical study, and sign an informed consent.
排除标准
- •Past history of malignant colorectal tumors or recent diagnosis combined with other malignant tumors;
- •Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery;
- •Neighboring organs need to be combined with organ resection;
- •New adjuvant therapy before surgery;
- •ASA grade ≥ grade IV and/or ECOG physical status score> 2 points;
- •Those who have severe liver and kidney function, cardiopulmonary function, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery;
- •Have a history of severe mental illness;
- •Pregnant or lactating women;
- •Patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial.
结局指标
主要结局
Number of lymph nodes harvested
时间窗: During the operation
Number of lymph nodes harvested
次要结局
- 3-year disease-free survival(3 years after surgery)
- Operation time(During the operation)
- Length of surgical incision(During the operation)
- Intraoperative blood loss(During the operation)
- Intraoperative concversion rate(During the operation)
- Postoperative recovery(During the postoperative hospital stay)
- 5-year overall survival(5 years after surgery)
研究者
Quan Wang
Professor
The First Hospital of Jilin University
研究点 (1)
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