Electroacupuncture Versus Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
A Randomized Clinical Trial of Electroacupuncture Versus Fast-track Perioperative Program for Reducing Duration of Postoperative Ileus and Hospital Stay After Laparoscopic Colorectal Surgery
Background: Our previous study demonstrated that electroacupuncture at Zusanli, Sanyinjiao, Hegu, and Zhigou reduces the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery within a traditional perioperative care setting. Recent evidence also suggested that a 'fast-track' perioperative program may help accelerate recovery after colorectal surgery. As electroacupuncture is simpler to implement and less labor intensive, it may be the preferred adjunct therapy if it is proven to be noninferior to fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery.
Objectives: To compare the efficacy of electroacupuncture and fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery.
Design: Prospective, randomized, noninferiority trial.
Subjects: One hundred sixty-four consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer will be recruited.
Interventions: Patients will be randomly allocated to receive either: (A) electroacupuncture with traditional perioperative care; or (B) fast-track program without acupuncture.
Outcome measures: Primary outcome: time to defecation. Secondary outcomes: duration of hospital stay, time of first passing flatus, time to resume diet, pain scores, analgesic requirement, morbidity, and medical costs.
Conclusions: This study will determine if electroacupuncture is noninferior to fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery. Electroacupuncture may be the preferred perioperative adjunct therapy to laparoscopic colorectal surgery because it is simpler to implement and less labor intensive than fast-track program.
調査の概要
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
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Hong Kong、中国
- 募集
- Prince of Wales Hospital, the Chinese University of Hong Kong
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副調査官：
- Tony WC Mak, MD
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コンタクト：
- Tony WC Mak, MD
- 電話番号：(852) 2632 1495
- メール：tonymak@surgery.cuhk.edu.hk
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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 80 years
- Patients with American Society of Anesthesiologists (ASA) 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 evidence of peritoneal carcinomatosis
- Patients with previous history of midline laparotomy
- Patients who are expected to receive epidural opioids for postoperative pain management
- Patients with cardiac pacemaker
- Patients who are allergic to the acupuncture needles
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 |
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実験的：Electroacupuncture
Bilateral acupoints relevant to the treatment of abdominal pain, abdominal distension, and constipation, including Zusanli (stomach meridian ST-36), Sanyinjiao (spleen meridian SP-6), Hegu (large intestine meridian LI-4), and Zhigou (triple energizer meridian TE-6), will be used.
Electric stimulation at a frequency of 50 Hz will be employed to the acupuncture needles.
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アクティブコンパレータ：Fast-track program
The design of this program is based on the consensus between our surgeons, anesthetists, physiotherapists, dietitians, and nurses, who have reviewed the relevant literature and made appropriate adjustments to suit the local situation.
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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 |
|---|---|---|
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排便までの時間
時間枠：最長1ヶ月
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腹腔鏡手術が終了してから最初に便の通過が観察されるまで、時間単位で測定されます。
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最長1ヶ月
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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患者が報告した最初の放屁の時間
時間枠：最長1ヶ月
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最長1ヶ月
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患者が固形食に耐えられる時間
時間枠：最長1ヶ月
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最長1ヶ月
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一人で歩く時間
時間枠：1ヶ月まで
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1ヶ月まで
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再入院率
時間枠：最長1ヶ月
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最長1ヶ月
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Total postoperative hospital stay
時間枠：Up to 1 month
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Including hospital stay of patients who are readmitted within 30 days after surgery.
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Up to 1 month
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Pain scores on visual analog scale
時間枠：Up to 1 month
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From 0 which implies no pain at all, to 100 which implies the worst pain imaginable; assessed at 4, 12, 24, 48, and 72 hours after surgery.
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Up to 1 month
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Morbidity
時間枠：Up to 1 month
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Up to 1 month
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Mortality
時間枠：Up to 1 month
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Up to 1 month
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Quality of life
時間枠：Up to 1 month
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Quality of life at 2 and 4 weeks after surgery, measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires
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Up to 1 month
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協力者と研究者
捜査官
- 主任研究者：Simon S. M. Ng, MD、Chinese University of Hong Kong
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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
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