Laparoscopic Surgery for Colorectal Cancer
ProcedureLaparoscopic surgery for colorectal cancer using STORZ laparoscope
Other names: STORZ laparoscope
NCT Number: NCT01080547
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Second Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, Zhejiang, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Laparoscopic surgery for colorectal cancer using STORZ laparoscope
Other names: STORZ laparoscope
XELOX chemotherapy
Other names: Capecitabine, Oxaliplatin
Conventional (mFolfox6) chemotherapy
Other names: Oxaliplatin
Fast track treatment during perioperation period
Other names: Fast track surgery
Conventional treatment during perioperation period
Other names: Traditional Perioperative Treatment
Open surgery for colorectal cancer using conventional methods
Other names: Traditional open surgery
Time frame: 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).
Time frame: 3-month post surgery
Surgical complications include injury of ureter, intraoperative transfusion, infection of incision and anastomotic leakage etc.
Time frame: 6-month post surgery
Chemotherapy related adverse event, according to NCI CTCAE Version 3.0, include nausea, vomit, diarrhea and neutropenia etc.
Time frame: preoperation, 3-month post surgery and 6-month post surgery
Quality of life will be measured by EORTC QLQ-C30 and QLQ-CR38 questionaire.
Time frame: 6-month post surgery
The overall hospitalization costs from the first day in hospital to day that adjuvant chemotherapy finished.
Zhejiang University
Other
Randomized Controlled Trial Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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