NCT06637215招募中不适用
Open, Parallel, Randomized Controlled, Non-inferior, Phase III Clinical Research on the Treatment Model of Ambulatory Surgery for Colorectal Cancer
First Hospital of China Medical University1 个研究点 分布在 1 个国家目标入组 352 人开始时间: 2023年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Recurrence-free survival (DFS)
研究概览
简要总结
To investigate the postoperative complication incidence and long-term efficacy between ambulatory surgery for colorectal cancer and traditional laparoscopic colorectal surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 joined this study and signed an informed consent form；
- •Age: 18-75 years old；
- •The patient should have a good general condition and no serious internal medicine comorbidities (ASA classification of the American Anesthesiology Association is Grade I~III)；
- •Complete colonoscopy and colonoscopy biopsy, and the pathology is confirmed to be adenocarcinoma/high-level intraepithelial neoplasia；
- •Enhanced CT or MRI examination before surgery, indicating that the tumor diameter is ≤5.0 cm；
- •Preoperative staging: cT1-3NanyM0;
- •Strictly follow the colorectal day surgery plan, and micro-laparoscopic radical colorectal cancer treatment can be adopted；
- •There are no contraindications for abdominal wall nerve block anesthesia or non-opiate analgesic drugs;
- •Does not require conventional anticoagulant therapy or antiplatelet therapy；
- •Relatives or co-residents should be able to provide 24 hours of full escort within at least 72 hours after the operation, the place of residence is not more than a 30-minute drive from the hospital, and they can understand and follow the phased treatment plan of diet, analgesic drugs, etc. after the operation.
排除标准
- •Elderly patients with multiple basic diseases；
- •Moderate to severe anemia；
- •Severe hypoproteinemia；
- •Diabetes that is not well controlled；
- •Contraindications to laparoscopic surgery；
- •Cases of emergency surgery due to acute intestinal obstruction, perforation or bleeding；
- •Patients with distant metastases；
- •Patients who are unwilling to sign informed consent or follow-up according to the research plan；
- •People with a history of psychotropic drug abuse and unable to quit or have mental disorders；
- •Patients who live alone or in psychosocial isolation, patients who cannot understand the postoperative nursing process；
- •After the operation, the place of residence is far away from the treated hospital or patients with insufficient medical resources and inconvenient transportation；
- •According to the judgment of the researcher, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the patient's research.
结局指标
主要结局
Recurrence-free survival (DFS)
时间窗: From enrollment to the end of treatment at 36 months
Overall survival (OS)
时间窗: From enrollment to the end of treatment at 36 months
次要结局
- BIood system disorders(From enrollment to the end of treatment at 1 week)
- Pain evaluation(From one hour after surgery to the end of treatment at 48 hours)
- Cardiac disorders(From enrollment to the end of treatment at 1 week)
- CoIonic fistuIa(From enrollment to the end of treatment at 1 week)
- AbdominaI infection(From enrollment to the end of treatment at 1 week)
- AnorectaI infection(From enrollment to the end of treatment at 1 week)
- Fever(From enrollment to the end of treatment at 1 week)
研究者
Kai Li
Deputy Director of surgical Oncology
First Hospital of China Medical University
研究点 (1)
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