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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Fast-track perioperative program; Other: Traditional perioperative program

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Prince of Wales Hospital, The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fast-track perioperative program	Other: 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
Active Comparator: Traditional perioperative program	Other: 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

What is the study measuring?

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
Direct/indirect medical costs and out-of-hospital economic costs		Up to 1 month
Readmission rate		Up to 1 month
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
Quality of life	Measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires	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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: April 20, 2011
• First Submitted That Met QC Criteria: April 22, 2011
• First Posted (Estimate): April 25, 2011

Study Record Updates

• Last Update Posted (Estimate): April 30, 2013
• Last Update Submitted That Met QC Criteria: April 29, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Laparoscopic surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CRE-2008.552-T