Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

Last updated: April 29, 2013
Sponsor: Chinese University of Hong Kong
Overall Status: Completed

Phase

3

Condition

Rectal Cancer

Colon Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT01341366
CRE-2008.552-T
  • Ages 18-75
  • All Genders

Study 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

Inclusion criteria:

  • Consecutive patients undergoing elective laparoscopic resection of colonic and upperrectal 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

Exclusion criteria:

  • Patients undergoing laparoscopic low anterior resection with total mesorectalexcision, 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 Design

Total Participants: 128
Study Start date:
November 01, 2010
Estimated Completion Date:
March 31, 2013

Connect with a study center

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

    Hong Kong,
    China

    Site Not Available

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