Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
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
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.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
-
Hong Kong、中国
- Prince of Wales Hospital, the Chinese University of Hong Kong
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
|
アクティブコンパレータ：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Duration of hospital stay
時間枠：Up to 1 month
|
Total postoperative hospital stay, including hospital stay of patients who are readmitted within 30 days after surgery.
|
Up to 1 month
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
直接・間接の医療費と院外経済費
時間枠：1ヶ月まで
|
1ヶ月まで
|
|
|
再入院率
時間枠：最長1ヶ月
|
最長1ヶ月
|
|
|
Pain scores
時間枠：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)
|
Up to 1 week
|
|
Morbidity and mortality
時間枠：Up to 1 month
|
Up to 1 month
|
|
|
Quality of life
時間枠：Up to 1 month
|
Measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires
|
Up to 1 month
|
|
Systemic cytokine responses
時間枠：Up to 1 week
|
Blood levels of IL-1β, IL-6, and C-reactive protein
|
Up to 1 week
|
|
Lymphocyte subsets
時間枠：Up to 1 week
|
Using flow cytometer to determine lymphocyte subsets and NK cell counts (cells/uL)
|
Up to 1 week
|
協力者と研究者
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。