Evaluation of Short-term Outcomes of Laparoscopic Radical Resection for Patients With Colon and Upper Rectum in Day Surgery Center
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of transfer to inpatient ward
研究概览
简要总结
To evaluate the feasibility and safety of laparoscopic colectomy and anterior resection for patients with colon/upper rectal cancer (CuRC) in day surgery center. Patients with colon or upper rectal cancer who meet the standards of day surgery will be enrolled, and laparoscopic radical resection of tumor will be performed in day surgery center. Perioperative outcomes of these patients and reasons for transferring to inpatient ward will be recorded prospectively.
详细描述
At present, with the development of laparoscopic surgery and the application of rapid rehabilitation, colorectal surgery has made great progress . At the same time, the application of evidence-based surgery and multimodal anesthesia in postoperative rehabilitation has accelerated the postoperative recovery. Moreover, several previous studies have shown that the implementation of ambulatory colorectal surgery can reduce the incidence of postoperative complications and shorten hospital stay. With the continuous development of rehabilitation surgery, the hospitalization time of colorectal surgery has been gradually shortened. In addition, studies had preliminarily proved the feasibility, safety and repeatability of outpatient colectomy and showed that 30% of patients with elective colectomy can be completed in outpatient department.
Therefore, the investigators designed the clinical pathway of day surgery for patients screened by outpatient department, so that these patients can complete laparoscopic radical resection of colon cancer or high rectal cancer in the day surgery center.
The aim of this study is to evaluate the feasibility and safety of day surgery center for patients with colon/upper rectal cancer (CuRC). Patients meet the inclusion criteria and exclusion criteria will be assigned to day surgery center to perform radically laparoscopic colectomy or anterior resection. Outcomes of interests including incidence of transfer to inpatient ward, readmission, perioperative adverse events will be recorded prospectively.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients under 65 years old with colorectal cancer or patients older than 65 years assessed by anesthesiologist that their physical conditions were excellent;
- •Tumor located higher than 10cm by colonoscopy, and It is expected that the distal resection margin is above the peritoneal reflexes;
- •Tumor location was diagnosed clearly by abdominal CT, no severe local invasion required extensive resection, and no intraoperative colonoscopy was needed to determine the tumor site;
- •No distant metastasis assessed by preoperative imaging examination ；
- •There was no special abnormality in blood routine, blood biochemistry, blood coagulation, electrocardiogram and pulmonary function, and anesthesiologist assessed that the patient was safe for day surgery
排除标准
- •Patients with distant metastasis
- •Patients with ASA grade >Ⅲ and high risk in perioperative period are expected
- •Tumor was too small to clearly showed by abdominal CT, and Intraoperative colonoscopy is needed.
- •Patients who need neoadjuvant therapy (preoperative chemoradiotherapy)
结局指标
主要结局
Incidence of transfer to inpatient ward
时间窗: one month after operation
The incidence of patients who did not transfer to community hospital according to the plan after operation, and the causes of this situation.
次要结局
- Mortality(90 days after surgery)
- Length of Hospital stay (LOS)(3 months after admission)
- Blood loss(during the operation)
- Readmission rate(90 days after surgery)
- operation duration time(during the operation)
- Postoperative complications(3 months after the surgery)
- Costs of hospital expense(3 months after admission)
研究者
Ziqiang Wang,MD
Clinical professor
West China Hospital