Colorectal Cancer
Conditions
Keywords
Laparoscopic surgery
Brief summary
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.
Interventions
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
OTHERTraditional perioperative program
Preoperative fasting, standard anesthetic management with no intraoperative fluid restriction, opioid pain management, no chewing gum, feeding/mobilization according to attending surgeon
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer, * Age of patients between 18 and 75 years * Patients with American Society of Anesthesiologists grading I-II * Patients with no severe physical disability * Patients who require no assistance with the activities of daily living * Informed consent available
Exclusion criteria
* Patients undergoing laparoscopic low anterior resection with total mesorectal excision, abdominoperineal resection, or total/proctocolectomy * Patients with planned stoma creation * Patients undergoing emergency surgery * Patients with known metastatic disease * Patients with previous history of abdominal surgery * Patients with known immunological dysfunction * Patients who are taking steroids or immunosuppressive agents * Patients with chronic pain syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospital stay | Up to 1 month | Total postoperative hospital stay, including hospital stay of patients who are readmitted within 30 days after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Direct/indirect medical costs and out-of-hospital economic costs | Up to 1 month | — |
| Systemic cytokine responses | Up to 1 week | Blood levels of IL-1β, IL-6, and C-reactive protein |
| Pain scores | Up to 1 week | Pain scores on visual analogue scale (from 0 which implies no pain at all, to 100 which implies the worst pain imaginable) |
| Quality of life | Up to 1 month | Measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires |
| Readmission rate | Up to 1 month | — |
| Lymphocyte subsets | Up to 1 week | Using flow cytometer to determine lymphocyte subsets and NK cell counts (cells/uL) |
| Morbidity and mortality | Up to 1 month | — |
Countries
China
Outcome results
None listed