Clinical trial NCT01341366: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: Laparoscopic surgery
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2011-04-25
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Duration of hospital stay
timeFrame: Up to 1 month
Secondary outcomes:
measure: Pain scores
timeFrame: Up to 1 week
measure: Morbidity and mortality
timeFrame: Up to 1 month
measure: Readmission rate
timeFrame: Up to 1 month
measure: Quality of life
timeFrame: Up to 1 month
measure: Direct/indirect medical costs and out-of-hospital economic costs
timeFrame: Up to 1 month
measure: Systemic cytokine responses
timeFrame: Up to 1 week
measure: Lymphocyte subsets
timeFrame: Up to 1 week
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital, The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Simon SM Ng, MD
role: PRINCIPAL_INVESTIGATOR
References: