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
- Postoperative hospital stays
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
研究组 & 干预措施
SILS plus one assistant ERAS
Preoperative:
preadmission information, education, counseling, optimization ( breathing training), shortening fasting time and carbohydrate load
Intraoperative:
The intravenous fluid therapy is restricted. All patients undergo single incision plus one port laparoscopic surgery(SILS plus one).
A suitable warming device (such as forced-air heating blankets) and warmed intravenous fluids are been adopted routinely to keep body temperature
Postoperative:
multimodal analgesia (surgical site infiltration, a nonsteroidal anti-inflammatory drug, epidural analgesia) early oral intake and move. nasogastric tubes should not be used routinely. Nasogastric tubes inserted during surgery are been removed before reversal of an aesthesia.
干预措施: Single incision plus one port laparoscopic surgery (Combination Product)
结局指标
主要结局
Postoperative hospital stays
时间窗: 1 month
Days from surgery to discharge
Rehabilitative rate
时间窗: 4 days
The percentage of patients who met discharge criteria in the fourth day after surgery
次要结局
- compliance with ERAS measures(perioperative)
- Morbidity and mortality rates(30 days)
- 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)