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NCT Number: NCT01341366

Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fast-track perioperative program

Other

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

Other

Preoperative fasting, standard anesthetic management with no intraoperative fluid restriction, opioid pain management, no chewing gum, feeding/mobilization according to attending surgeon

Primary outcomes

  1. Duration of hospital stay

    Time frame: Up to 1 month

    Total postoperative hospital stay, including hospital stay of patients who are readmitted within 30 days after surgery.

Secondary outcomes

  1. Pain scores

    Time frame: Up to 1 week

    Pain scores on visual analogue scale (from 0 which implies no pain at all, to 100 which implies the worst pain imaginable)

  2. Morbidity and mortality

    Time frame: Up to 1 month

  3. Readmission rate

    Time frame: Up to 1 month

  4. Quality of life

    Time frame: Up to 1 month

    Measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires

  5. Direct/indirect medical costs and out-of-hospital economic costs

    Time frame: Up to 1 month

  6. Systemic cytokine responses

    Time frame: Up to 1 week

    Blood levels of IL-1β, IL-6, and C-reactive protein

  7. Lymphocyte subsets

    Time frame: Up to 1 week

    Using flow cytometer to determine lymphocyte subsets and NK cell counts (cells/uL)

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Apr 25, 2011
Registry last updated
Apr 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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