Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Fast-track perioperative program
Traditional perioperative program
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Laparoscopic surgery
Eligibility Criteria
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
Sites / Locations
- Prince of Wales Hospital, The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fast-track perioperative program
Traditional perioperative program
Arm Description
Outcomes
Primary Outcome Measures
Duration of hospital stay
Total postoperative hospital stay, including hospital stay of patients who are readmitted within 30 days after surgery.
Secondary Outcome Measures
Pain scores
Pain scores on visual analogue scale (from 0 which implies no pain at all, to 100 which implies the worst pain imaginable)
Morbidity and mortality
Readmission rate
Quality of life
Measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires
Direct/indirect medical costs and out-of-hospital economic costs
Systemic cytokine responses
Blood levels of IL-1β, IL-6, and C-reactive protein
Lymphocyte subsets
Using flow cytometer to determine lymphocyte subsets and NK cell counts (cells/uL)
Full Information
NCT ID
NCT01341366
First Posted
April 20, 2011
Last Updated
April 29, 2013
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01341366
Brief Title
Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Laparoscopic surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fast-track perioperative program
Arm Type
Experimental
Arm Title
Traditional perioperative program
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Fast-track perioperative program
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Traditional perioperative program
Intervention Description
Preoperative fasting, standard anesthetic management with no intraoperative fluid restriction, opioid pain management, no chewing gum, feeding/mobilization according to attending surgeon
Primary Outcome Measure Information:
Title
Duration of hospital stay
Description
Total postoperative hospital stay, including hospital stay of patients who are readmitted within 30 days after surgery.
Time Frame
Up to 1 month
Secondary Outcome Measure Information:
Title
Pain scores
Description
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
Title
Morbidity and mortality
Time Frame
Up to 1 month
Title
Readmission rate
Time Frame
Up to 1 month
Title
Quality of life
Description
Measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires
Time Frame
Up to 1 month
Title
Direct/indirect medical costs and out-of-hospital economic costs
Time Frame
Up to 1 month
Title
Systemic cytokine responses
Description
Blood levels of IL-1β, IL-6, and C-reactive protein
Time Frame
Up to 1 week
Title
Lymphocyte subsets
Description
Using flow cytometer to determine lymphocyte subsets and NK cell counts (cells/uL)
Time Frame
Up to 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon SM Ng, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital, The Chinese University of Hong Kong
City
Hong Kong
Country
China
12. IPD Sharing Statement
Links:
URL
http://www.surgery.cuhk.edu.hk
Description
Related Info
Learn more about this trial
Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
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