Effect of Single Incision Plus One Port Laparoscopic Surgery Assistant Enhanced Recovery After Surgery on Colorectal Cancer : A Single Arm Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 主要终点
- Rehabilitative rate
研究概览
简要总结
Conventional laparoscopic surgery (CLS) for colorectal cancer has been demonstrated to be safe and feasible and present minimally invasive benefits including faster recovery, reduced postoperative pain and shorter hospital stay, also acquiring comparable oncologic outcomes with open surgery. To achieve further minimally invasive outcomes, SILS plus one port surgery was attempted by some surgeons. Preliminary results showed that SILS+1 could achieve better minimally invasive benefits than CLS while preserving oncologic feasibility.
Till now, ERAS has been practiced in colorectal cancer surgery for approximately 20 years. Studies have proven that ERAS is safe and significantly improved the recovery course of patients during perioperative period, meanwhile, the expense could be greatly reduced.
Based on ERAS studies protocols and SILS+1 trials, investigators tried to combine SILS+1 with ERAS, hopefully to provide patients with more safe, economic, feasible and rapid surgery and perioperative strategies.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary tumor diagnosed as adenocarcinoma confirmed pathologically by endoscopic biopsy
- •cT1-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition
- •Located in the cecum, ascending colon, transverse colon, descending colon, sigmoid colon, the upper segment of the rectum.
- •Diameter ≦ 5cm
- •No severe organ dysfunction
- •Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- •ASA (American Society of Anesthesiology) score class I or II
- •Written informed consent
排除标准
- •Unsuitable for patients undergoing single incision plus one port laparoscopic surgery
- •Patients with Complications caused by colorectal cancer ( bleeding , perforation, obstruction or incomplete obstruction )
- •Previous abdominal surgery
- •Malignant diseases within the past 5years
- •Requirements of simultaneous surgery for another diseases
结局指标
主要结局
Rehabilitative rate
时间窗: 4 days
The percentage of patients who met discharge criteria in the fourth day after surgery
Postoperative hospital stays
时间窗: 1 month
Days from surgery to discharge
次要结局
- 6 min postoperative walking test(6MWT)(Once a day from the frist to the fourth day after surgery)
- hospital readmissions(30days)
- Medical cost(1 month)
- Postoperative recovery index(1 month)
- Postoperative pain score(Once a day from 6 hours to the fourth day after surgery)
- Postoperative inflammatory immune response(3 days)
- compliance with ERAS measures(perioperative)
- Morbidity and mortality rates(30 days)