Preoperative Loading With Carbohydrates in Lung Cancer Surgery
Administration of preoperative oral carbohydrates are suggested to reduce insulin resistance due to surgical stress.
The aim of this study is to investigate whether preoperative oral carbohydrate loading can contribute to lower incidence of postoperative discomfort and to reduce complications in elective lung cancer patients undergoing video assisted thorascopic surgery (VATS).
調査の概要
詳細な説明
Fasting from 6-12hours before elective surgery is still standard of care in many departements, including our departement in Oslo University Hospital.
Surgery is a trauma that triggers a catabolic stress response with high emissions of hormones and immune activation. These activations can affect brain, heart, muscles and liver. The metabolic changes may in addition influence development of pain, tissue damage, ileus, tachycardia and other hemodynamic disturbances. Preoperative fasting has shown an increase of surgical stress and to impact catabolic processes which secondarily may lead to insulin resistance and hyperglycemia in non-diabetic patients. Insulin resistance and hyperglycaemia are known to increase the incidence of postoperative infections. Previous studies have also shown that prolonged fasting increases the incidence of gastrointestinal problems. A 12 hour fast before surgery has shown delayed recovery.
Studies have shown that patients undergoing lung cancer surgery suffer from multiple symptoms and experience discomfort in the postoperative phase. Symptoms include dyspnea, fatigue, pain, weakness, cough, dry mouth, nervousness, difficulty sleeping, stomach-/intestinal-problems and lack of appetite. Carbohydrate-rich supplements have shown a positive effect on other perioperative symptoms and measures, but is to our knowledge currently not investigated in lung cancer surgery.
Therefore, there is a need to explore the possible advantages of preoperative oral carbohydrate loading in lung cancer surgery.
The primary aim of this study is to investigate whether preoperative carbohydrate loading with PreOp® provides less postoperative discomfort in the early postoperative phase measured by Quality of Recovery-40 (QoR-40), a validated and widely used measure of quality of recovery.
The secondary aim is to investigate if preoperative loading with carbohydrates affect the incidence of postoperative complications such as stomach-/intestinal problems and heart rhythm disorder, in addition to contribute to faster mobilization and to reduce hospital length of stay.
This study may provide important data regarding the lung cancer patients perioperative symptoms, complications and well-being when using a carbohydrate-rich supplement as intervention to standard of care.
In this study, the intervention group will be given 800ml of a oral carbohydrate supplement, PreOp®, the night before surgery and 400ml of the same supplement, PreOp®, 2-4 hours prior to surgery. The control group will be fasted from 24h, the night before surgery, in accordance to the departements standard of care.
Both groups, the interventional and the control group, will follow the department's perioperative course with regard to anesthetic and surgical procedures.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Oslo、ノルウェー、0450
- 募集
- Oslo University Hospital
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コンタクト:
- Per Reidar Woldbaek, MD, PhD
- 電話番号:+4798895427
- メール:uxpewo@ous-hf.no
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コンタクト:
- Astrid Krohn-Hansen, RN
- 電話番号:+4792270669
- メール:astkro@ous-hf.no
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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:
adult patients undergoing elective video-assisted thoracoscopic surgery due to lung neoplasms.
- ability to understand and speak Norwegian
Exclusion Criteria:
- impaired gastric emptying
- diabetes
- ongoing treatment for pain
- ongoing infection
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:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
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:Interventional group
Carbohydrate-rich, dietary supplement: PreOp® 800ml day before surgery and PreOp® 400ml 2-4hours preoperative.
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No preoperative drink.
他の名前:
|
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介入なし:Control group
Standard of care: Fasting from 24hours (midnight), night before surgery.
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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 |
|---|---|---|
|
Postoperative discomfort measured by the questionnaire "Quality of recovery 40" (QoR-40) measured on the first postoperative day.
時間枠:First postoperative day
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Postoperative discomfort measured by the questionnaire "Quality of recovery 40" (QoR-40) measured on the first postoperative day.
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First postoperative day
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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 |
|---|---|---|
|
Gastrointestinal discomfort postoperatively.
時間枠:First seven postoperative days.
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Number of patients experiencing nausea, vomiting, diarrhea and/or obstipation.
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First seven postoperative days.
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Heart rhythm disturbances postoperatively.
時間枠:First seven postoperative days.
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Number of patients with arrhythmia lasting more than 5 min or treated with antiarrhythmic agents.
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First seven postoperative days.
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Time to mobilization.
時間枠:First seven postoperative days.
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Time to mobilization out of bed (to chair or walking) as registered by the attending nurse.
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First seven postoperative days.
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Length of stay
時間枠:First seven postoperative days.
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Length of hospital stay to discharge for index admission.
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First seven postoperative days.
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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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