Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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The Impact of Fast-track Perioperative Program on the Clinical and Immunological Outcomes After Laparoscopic Colorectal Surgery in Hong Kong Chinese Patients: A Prospective Randomized Trial

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Fast-track perioperative program
* Other: Traditional perioperative program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fast-track perioperative program<br> | Other: Fast-track perioperative program<br>* 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<br>|
| Active Comparator: Traditional perioperative program<br> | Other: Traditional perioperative program<br>* Preoperative fasting, standard anesthetic management with no intraoperative fluid restriction, opioid pain management, no chewing gum, feeding/mobilization according to attending surgeon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic surgery