Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
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
1 other identifier
interventional
128
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 colorectal-cancer
Started Nov 2010
Shorter than P25 for phase_3 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 20, 2011
CompletedFirst Posted
Study publicly available on registry
April 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedApril 30, 2013
April 1, 2013
2.3 years
April 20, 2011
April 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Pain scores
Up to 1 week
Morbidity and mortality
Up to 1 month
Readmission rate
Up to 1 month
Quality of life
Up to 1 month
Direct/indirect medical costs and out-of-hospital economic costs
Up to 1 month
- +2 more secondary outcomes
Study Arms (2)
Fast-track perioperative program
EXPERIMENTALTraditional perioperative program
ACTIVE COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simon SM Ng, MD
Chinese University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 20, 2011
First Posted
April 25, 2011
Study Start
November 1, 2010
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
April 30, 2013
Record last verified: 2013-04