跳至主要内容
临床试验/NCT01341366
NCT01341366已完成3 期

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

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
128
试验地点
1
主要终点
Duration of hospital stay

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Duration of hospital stay

时间窗: Up to 1 month

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

次要结局

  • Pain scores(Up to 1 week)
  • Morbidity and mortality(Up to 1 month)
  • Readmission rate(Up to 1 month)
  • Quality of life(Up to 1 month)
  • Direct/indirect medical costs and out-of-hospital economic costs(Up to 1 month)
  • Systemic cytokine responses(Up to 1 week)
  • Lymphocyte subsets(Up to 1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simon S. M. Ng

Professor

Chinese University of Hong Kong

研究点 (1)

Loading locations...

相似试验