Quality of Life Clinical Trial
Official title:
Randomized Controlled Trial Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer
Verified date | December 2016 |
Source | Zhejiang University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 374 |
Est. completion date | December 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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=? 9. Mid-low rectal cancer 10. Pregnant woman 11. Needing to use Chinese traditional patent drug |
Country | Name | City | State |
---|---|---|---|
China | Second Affiliated Hospital Zhejiang University College of Medicine | Hangzhou | Zhejiang |
China | People's Hospital of Shaoxing | Shaoxing | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | hospitalization day | 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). | 6-month post surgery | |
Secondary | surgical complications | Surgical complications include injury of ureter, intraoperative transfusion, infection of incision and anastomotic leakage etc. | 3-month post surgery | |
Secondary | chemotherapy related adverse event | Chemotherapy related adverse event, according to NCI CTCAE Version 3.0, include nausea, vomit, diarrhea and neutropenia etc. | 6-month post surgery | |
Secondary | quality of life | Quality of life will be measured by EORTC QLQ-C30 and QLQ-CR38 questionaire. | preoperation, 3-month post surgery and 6-month post surgery | |
Secondary | hospitalization costs | The overall hospitalization costs from the first day in hospital to day that adjuvant chemotherapy finished. | 6-month post surgery |
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