A Phase 3 interventional study of Fast-track perioperative program and Traditional perioperative program in Colorectal Cancer, sponsored by Chinese University of Hong Kong. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-04-30.
Sponsored by Chinese University of Hong Kong · Phase 3, Interventional, and Treatment
Background:
Laparoscopic colorectal surgery has been shown by randomized trials to be associated with better short-term clinical outcomes when compared with open surgery. However, in a traditional perioperative care setting, the reduction in hospital stay following laparoscopic surgery in these trials was modest. Fast-track perioperative programs have been introduced in the West to optimize perioperative factors to reduce the physiological/psychological stress of open colorectal surgery. However, few studies have evaluated the impact of fast-track programs on the outcomes after laparoscopic colorectal surgery.
Objective:
To compare the clinical and immunological outcomes of Hong Kong Chinese patients undergoing laparoscopic surgery for colorectal cancer with a "traditional" vs. a "fast-track" perioperative program.
Design:
Prospective randomized trial.
Subjects:
One hundred and twenty-eight consecutive patients undergoing elective laparoscopic resection of non-metastatic colonic and upper rectal cancer will be recruited.
Interventions:
Patients will be randomized to a "traditional" or a "fast-track" perioperative program.
Outcome measures:
Primary outcome: total postoperative hospital stay, including hospital stay of patients who are readmitted within 30 days after surgery. Secondary outcomes: immunological parameters (including systemic cytokine response and cell-mediated immune function), morbidity and mortality, quality of life, and medical costs.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 128 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
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Exclusion criteria:
Other: Fast-track perioperative program
Other: Traditional perioperative program
Preoperative counseling, no preoperative fasting, short-acting anesthetics, continuous infiltration of wound with local anesthetic agent, non-opioid pain management, the use of chewing gum, and early postoperative feeding and mobilization
Preoperative fasting, standard anesthetic management with no intraoperative fluid restriction, opioid pain management, no chewing gum, feeding/mobilization according to attending surgeon
Duration of hospital stay
Total postoperative hospital stay, including hospital stay of patients who are readmitted within 30 days after surgery.
Time frame: Up to 1 month
Pain scores
Pain scores on visual analogue scale (from 0 which implies no pain at all, to 100 which implies the worst pain imaginable)
Time frame: Up to 1 week
Morbidity and mortality
Time frame: Up to 1 month
Readmission rate
Time frame: Up to 1 month
Quality of life
Measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires
Time frame: Up to 1 month
Direct/indirect medical costs and out-of-hospital economic costs
Time frame: Up to 1 month
Systemic cytokine responses
Blood levels of IL-1β, IL-6, and C-reactive protein
Time frame: Up to 1 week
Lymphocyte subsets
Using flow cytometer to determine lymphocyte subsets and NK cell counts (cells/uL)
Time frame: Up to 1 week
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong