Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01341366
• Other study ID #: CRE-2008.552-T
• Status: Completed
• Phase: Phase 3
• First received: April 20, 2011
• Last updated: April 29, 2013
• Start date: November 2010
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

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
• 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

Locations

Country	Name	City	State
China	Prince of Wales Hospital, The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Morbidity and mortality		Up to 1 month	Yes
Secondary	Readmission rate		Up to 1 month	No
Secondary	Quality of life	Measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires	Up to 1 month	No
Secondary	Direct/indirect medical costs and out-of-hospital economic costs		Up to 1 month	No
Secondary	Systemic cytokine responses	Blood levels of IL-1ß, IL-6, and C-reactive protein	Up to 1 week	No
Secondary	Lymphocyte subsets	Using flow cytometer to determine lymphocyte subsets and NK cell counts (cells/uL)	Up to 1 week	No

External Links

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