Randomized Controlled Trial Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 374
- 试验地点
- 2
- 主要终点
- hospitalization day
研究概览
简要总结
A new notion"Fast Track Multi-Discipline Treatment" for colorectal cancer is thought with several benefits such as shorter hospitalization stay and less costs. This randomized study aims to compare the differences between conventional and Fast Track Multi-Discipline Treatment for colorectal cancer in hospitalization day, complications, costs and quality of life.
详细描述
Laparoscopic Surgery, Fast Track Treatment and XELOX Chemotherapy have been introduced in the treatment of colorectal cancer. All of these procedures are contributed to reduce the hospitalization stay. However, the most economical mode for combination of these procedures is still unclear. This is a randomized controlled study, a new notion"Fast Track Multi-Discipline Treatment" is proposed, which is the combination of the Laparoscopic Surgery, Fast track perioperative treatment during perioperative period and XELOX Chemotherapy. The purpose of this study is to compare the Fast Track Multi-Discipline Treatment with the conventional treatment(Open Surgery with conventional treatment during perioperative period and mFolfox6 chemotherapy) for colorectal cancer on several aspects like the average hospitalization day, complications, costs and quality of life.The focus of the study will be to investigate whether the Fast Track Multi-Discipline Treatment reduces hospital stay with similar complications compared with conventional perioperative treatment. Moreover, the trial will clarify whether laparoscopic surgery is essential for Fast Track Multi-Discipline Treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pathologically confirmed colorectal cancer
- •Signed consent
排除标准
- •Tumor can be resected by endoscopic mucosal resection(EMR)
- •History of malignancy
- •Bowel obstruction or intestinal perforation
- •Evidence of metastasis by physical examination, chest roentgenogram and computed tomography of liver and pelvis
- •Acute diseases and acute attack of chronic diseases
- •Psychiatric history
- •Deformity of spine
- •ASA score≥Ⅳ
- •Mid-low rectal cancer
- •Pregnant woman
- •Needing to use Chinese traditional patent drug
研究组 & 干预措施
Conventional Treatment （Laparoscopic）
Randomized group of patients receiving laparoscopic colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
干预措施: Laparoscopic Surgery for Colorectal Cancer (Procedure)
Conventional Treatment （Laparoscopic）
Randomized group of patients receiving laparoscopic colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
干预措施: mFolfox6 chemotherapy (Drug)
Conventional Treatment （Laparoscopic）
Randomized group of patients receiving laparoscopic colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
干预措施: Conventional Perioperative Treatment (Other)
FTMD Treatment （Laparoscopic）
Randomized group of patients receiving laparoscopic colectomy with Fast Track Multi-Displine（FTMD）treatment and XELOX chemotherapy.
干预措施: Laparoscopic Surgery for Colorectal Cancer (Procedure)
FTMD Treatment （Laparoscopic）
Randomized group of patients receiving laparoscopic colectomy with Fast Track Multi-Displine（FTMD）treatment and XELOX chemotherapy.
干预措施: XELOX Chemotherapy (Drug)
FTMD Treatment （Laparoscopic）
Randomized group of patients receiving laparoscopic colectomy with Fast Track Multi-Displine（FTMD）treatment and XELOX chemotherapy.
干预措施: Fast Track Perioperative Treatment (Other)
Conventional Treatment（Open Surgery）
Randomized group of patients receiving open colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
干预措施: mFolfox6 chemotherapy (Drug)
Conventional Treatment（Open Surgery）
Randomized group of patients receiving open colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
干预措施: Conventional Perioperative Treatment (Other)
Conventional Treatment（Open Surgery）
Randomized group of patients receiving open colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
干预措施: Open Surgery for Colorectal Cancer (Procedure)
FTMD Treatment（Open Surgery）
Randomized group of patients receiving open colectomy with Fast Track Multi-Displine（FTMD） treatment and XELOX chemotherapy.
干预措施: XELOX Chemotherapy (Drug)
FTMD Treatment（Open Surgery）
Randomized group of patients receiving open colectomy with Fast Track Multi-Displine（FTMD） treatment and XELOX chemotherapy.
干预措施: Fast Track Perioperative Treatment (Other)
FTMD Treatment（Open Surgery）
Randomized group of patients receiving open colectomy with Fast Track Multi-Displine（FTMD） treatment and XELOX chemotherapy.
干预措施: Open Surgery for Colorectal Cancer (Procedure)
结局指标
主要结局
hospitalization day
时间窗: 6-month post surgery
The overall hospitalization stay during treatment from the first day in hospital to leave hospital when finish adjuvant chemotherapy or surgery (for patients who don't need chemotherapy).
次要结局
- chemotherapy related adverse event(6-month post surgery)
- surgical complications(3-month post surgery)
- hospitalization costs(6-month post surgery)
- quality of life(preoperation, 3-month post surgery and 6-month post surgery)
研究者
Ding Ke-Feng
Professor of SAHZU
Zhejiang University