Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

Phase 3

Completed

• Conditions: Colorectal Cancer
• Interventions: Other: Fast-track perioperative program; Other: Traditional perioperative program

• Registration Number: NCT01341366
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-04-22
• Study First Posted: 2011-04-25
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-29
• Last Update Posted: 2013-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fast-track perioperative program	Fast-track perioperative program	-
Traditional perioperative program	Traditional perioperative program	-

Primary Outcome Measures

Name	Time	Method
Duration of hospital stay	Up to 1 month	Total postoperative hospital stay, including hospital stay of patients who are readmitted within 30 days after surgery.

Secondary Outcome Measures

Name	Time	Method
Pain scores	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)
Morbidity and mortality	Up to 1 month
Readmission rate	Up to 1 month
Quality of life	Up to 1 month	Measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires
Direct/indirect medical costs and out-of-hospital economic costs	Up to 1 month
Systemic cytokine responses	Up to 1 week	Blood levels of IL-1β, IL-6, and C-reactive protein
Lymphocyte subsets	Up to 1 week	Using flow cytometer to determine lymphocyte subsets and NK cell counts (cells/uL)

Trial Locations

Locations (1)

Prince of Wales Hospital, The Chinese University of Hong Kong; 🇨🇳 Hong Kong, China