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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fast-track perioperative program | Experimental |
| |
| Traditional perioperative program | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fast-track perioperative program | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hospital stay | Total postoperative hospital stay, including hospital stay of patients who are readmitted within 30 days after surgery. | Up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores | Pain scores on visual analogue scale (from 0 which implies no pain at all, to 100 which implies the worst pain imaginable) | Up to 1 week |
| Morbidity and mortality | Up to 1 month |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon SM Ng, MD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital, The Chinese University of Hong Kong | Hong Kong | China |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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|
| Traditional perioperative program | Other | Preoperative fasting, standard anesthetic management with no intraoperative fluid restriction, opioid pain management, no chewing gum, feeding/mobilization according to attending surgeon |
|
| Readmission rate | Up to 1 month |
| Quality of life | Measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires | Up to 1 month |
| Direct/indirect medical costs and out-of-hospital economic costs | Up to 1 month |
| Systemic cytokine responses | Blood levels of IL-1β, IL-6, and C-reactive protein | Up to 1 week |
| Lymphocyte subsets | Using flow cytometer to determine lymphocyte subsets and NK cell counts (cells/uL) | Up to 1 week |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |