Length of Stay, Complications, Adverse Drug Event, Quality of Life, Hospital Costs
Conditions
Brief summary
A new notionFast 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.
Detailed description
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 notionFast 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.
Interventions
PROCEDURELaparoscopic Surgery for Colorectal Cancer
Laparoscopic surgery for colorectal cancer using STORZ laparoscope
XELOX chemotherapy
DRUGmFolfox6 chemotherapy
Conventional (mFolfox6) chemotherapy
OTHERFast Track Perioperative Treatment
Fast track treatment during perioperation period
OTHERConventional Perioperative Treatment
Conventional treatment during perioperation period
PROCEDUREOpen Surgery for Colorectal Cancer
Open surgery for colorectal cancer using conventional methods
Sponsors
Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with pathologically confirmed colorectal cancer 2. Signed consent
Exclusion criteria
1. Tumor can be resected by endoscopic mucosal resection(EMR) 2. History of malignancy 3. Bowel obstruction or intestinal perforation 4. Evidence of metastasis by physical examination, chest roentgenogram and computed tomography of liver and pelvis 5. Acute diseases and acute attack of chronic diseases 6. Psychiatric history 7. Deformity of spine 8. ASA score≥Ⅳ 9. Mid-low rectal cancer 10. Pregnant woman 11. Needing to use Chinese traditional patent drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hospitalization day | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| surgical complications | 3-month post surgery | Surgical complications include injury of ureter, intraoperative transfusion, infection of incision and anastomotic leakage etc. |
| chemotherapy related adverse event | 6-month post surgery | Chemotherapy related adverse event, according to NCI CTCAE Version 3.0, include nausea, vomit, diarrhea and neutropenia etc. |
| quality of life | preoperation, 3-month post surgery and 6-month post surgery | Quality of life will be measured by EORTC QLQ-C30 and QLQ-CR38 questionaire. |
| hospitalization costs | 6-month post surgery | The overall hospitalization costs from the first day in hospital to day that adjuvant chemotherapy finished. |
Countries
China
Outcome results
None listed