Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
NCT ID: NCT01341366
Last Updated: 2013-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
128 participants
INTERVENTIONAL
2010-11-30
2013-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fast-track perioperative program
Fast-track perioperative program
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
Traditional perioperative program
Traditional perioperative program
Preoperative fasting, standard anesthetic management with no intraoperative fluid restriction, opioid pain management, no chewing gum, feeding/mobilization according to attending surgeon
Interventions
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Fast-track perioperative program
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
Traditional perioperative program
Preoperative fasting, standard anesthetic management with no intraoperative fluid restriction, opioid pain management, no chewing gum, feeding/mobilization according to attending surgeon
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Simon S. M. Ng
Professor
Principal Investigators
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Simon SM Ng, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, , China
Countries
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Related Links
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Related Info
Other Identifiers
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CRE-2008.552-T
Identifier Type: -
Identifier Source: org_study_id