Safety and Feasibility of Laparoscopic Intracorporeal Anastomosis for Colorectal Surgery- A Multiple Center Real World Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- 3-year overall survival
研究概览
简要总结
The goal of this observational study is to explore the safety and feasibility of laparoscopic intracorporeal anastomosis in colorectal cancer surgery. The main questions it aims to answer are: 1. If intracorporeal anastomosis is safe in terms of short-term outcome? 2. If intracorporeal anastomosis can achieve the same oncological outcome as conventional extracorporeal anastomosis?
详细描述
This study is a retrospective real-world research initiated by the Chinese Academy of Medical Sciences Cancer Hospital, including Cancer Hospital of the Chinese Academy of Medical Sciences, Shenzhen Hospital and Peking University First Hospital. The study aims to retrospectively analyze the clinical data of approximately 2,000 patients who underwent laparoscopic surgery with preoperative imaging staging of cT1-4aNanyM0 and pathological diagnosis of adenocarcinoma or high-grade intraepithelial neoplasia from April 2016 to April 2020. The patients will be divided into the intracorporeal anastomosis group (IA) and extracorporeal anastomosis group (EA) based on the surgical records. The primary endpoints of the study are 3-year disease-free survival (DFS) and 3-year overall survival (OS). The secondary endpoints include overall complication rate within 30 days, postoperative pain score, time to first flatus after surgery, time to first bowel movement after surgery, time to first oral intake after surgery, length of hospital stay, and postoperative quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients voluntarily enrolled in this study and signed an informed consent form;
- •Age: 18-75 years;
- •Completion of colonoscopy and biopsy, with pathological confirmation of adenocarcinoma or high-grade intraepithelial neoplasia;
- •Preoperative enhanced CT or MRI examination showing no evidence of distant metastasis;
- •Preoperative staging as cT1-3NanyM0;
- •Underwent laparoscopic surgery.
排除标准
- •Contraindications to laparoscopic surgery;
- •Cases requiring emergency surgery due to acute bowel obstruction, perforation, or bleeding;
- •Patients with distant metastasis;
- •Patients with multiple primary colorectal cancers;
- •Patients with a history of malignancy;
- •Patients unwilling to sign the informed consent or unwilling to follow the study protocol for follow-up.
结局指标
主要结局
3-year overall survival
时间窗: 3 year
Percentage of patients who are still alive at the end of a 3-year period after surgery
3-year disease free survival
时间窗: 3 year
Proportion of patients who remain alive without any signs or symptoms of disease recurrence or progression for a period of 3 years after surgery
次要结局
- Length of stay after surgery(30 days)
- Rate of postoperative complications(30 days)
- Time to first flatus after surgery(7 days)
- Time to first stool after surgery(7 days)
- Postoperative pain score(3 days)
研究者
Jianqiang Tang
Associate professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences