Effects of Early Oral Feeding After Resection of Gastric Cancer
Phase III Clinical Trial for Effect Early Oral Feeding on Recovery After Resection of Gastric Cancer
調査の概要
詳細な説明
Most patients who undergo gastric resection for gastric cancer have maintained going on a fast of over three days after operation. Surgeons have believed that early oral feeding might worsen patients' condition by prolonged postoperative ileus. Therefore, patients received nothing by oral route until resolution of the ileus. However, the current trend toward minimal operative injury and early discharge from hospital. In addition, development of operative technique and instrument make the operation time to be short and the patients to be fast recovery, and thus it is possible to feed early in less than two days after operation. The aim of this study is to determine whether early oral feeding after curative resection for gastric cancer would be tolerable and give an effect on the recovery.
We collect fifty-eight patients for this study and divide into two groups using randomization method. In the early feeding group, patients will receive the liquid diet two day after operation followed by soft diet postoperative three day. Meanwhile, the patients who categorized into control group will start the liquid diet postoperative four day followed by soft diet postoperative six day. We evaluate the morbidity or mortality rate and laboratory findings. Of course, it is supposed to be same in amount of fluid and calories between two groups.
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
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Seoul、大韓民国、150-713
- St Mary's Hospital, The Catholic University of Korea
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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:
Patients who underwent gastrectomy for adenocarcinoma of stomach with following criteria:
- Performed curative resection
- Have The American Society of Anaesthesiologists (ASA) score of less than 3
Exclusion Criteria:
- Patients who have simultaneously other cancer.
- Patients who underwent gastric resection at past time.
- Patients who have cancer with bleeding or perforation or obstruction.
- Patients who have any injury to the pancreas capsule on operation.
- Patients who get pregnancy.
- Patients who are treating diabetics with Insulin.
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 |
---|---|
介入なし:1
Conventional feeding : They begin ingesting sips of water on third postoperative day and continued with a liquid diet for the next two days.
Patients were given a soft diet on sixth postoperative day.
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Procedure of Conventional feeding group: Patients are supplied water on day 3 after operation, liquid diet on day 4 and 5 and soft diet on 6 day.
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実験的:2
Early oral feeding : The patients begin ingesting sips of water on the first postoperative day.
If they are tolerable, they continued with a clear liquid diet the next day and a soft diet on the third post operative day.
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Procedure of Early oral feeding group: Patients are supplied water on day 1 after operation, liquid diet on day 2 and soft diet on day 3 day.
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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 |
---|---|---|
Days of hospital stay after operation
時間枠:within 30 days after operation
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We measure the length of hospital stay after operation
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within 30 days after operation
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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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Day of recovery of bowel sound and flatus: Evidence of recovery of bowel sound by physician's examination and Evidence of first flatus by question to patient
時間枠:within 30 days after operation
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We measure the days of flatus within 30 days after operation
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within 30 days after operation
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Laboratory findings after operation: Albumin, complete blood count, total cholesterol, cholinesterase and C-reactive protein are measured
時間枠:1,3,5 and 7 day after operation
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1,3,5 and 7 day after operation
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Symptom of Patients: Question to patients about symptoms
時間枠:before operation and 1,3,5,7 day after operation
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before operation and 1,3,5,7 day after operation
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Cost effectiveness: Total cost duration of hospitalization
時間枠:within 30 days after admission
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We measure total cost from admission to discharge after operation
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within 30 days after admission
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Quality of life: EORTC QLQ30, STO22
時間枠:1,2 and 3 month after operation
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1,2 and 3 month after operation
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Immunologic Outcomes : IL-1, IL-2, IL-6, IL-8, TNF-a will by measured by ELISA
時間枠:before operation and 1,3,5,7 day after operation
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before operation and 1,3,5,7 day after operation
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Postoperative morbidity rate in hospital days: Clinically definite morbidity confirmed by physicians according to offered protocol
時間枠:within 30 days after operation
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We observe the occurrence of morbidity after operation
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within 30 days after operation
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協力者と研究者
捜査官
- 主任研究者:Hae Myung Jeon, MD、Department of Surgery, St Mary's Hospital, The Catholic University of Korea
- スタディディレクター:Hoon Hur, MD、Department of Surgery, St Mary's Hospital, The Catholic University of Korea
出版物と役立つリンク
一般刊行物
- Reissman P, Teoh TA, Cohen SM, Weiss EG, Nogueras JJ, Wexner SD. Is early oral feeding safe after elective colorectal surgery? A prospective randomized trial. Ann Surg. 1995 Jul;222(1):73-7. doi: 10.1097/00000658-199507000-00012.
- Suehiro T, Matsumata T, Shikada Y, Sugimachi K. Accelerated rehabilitation with early postoperative oral feeding following gastrectomy. Hepatogastroenterology. 2004 Nov-Dec;51(60):1852-5.
- Gabor S, Renner H, Matzi V, Ratzenhofer B, Lindenmann J, Sankin O, Pinter H, Maier A, Smolle J, Smolle-Juttner FM. Early enteral feeding compared with parenteral nutrition after oesophageal or oesophagogastric resection and reconstruction. Br J Nutr. 2005 Apr;93(4):509-13. doi: 10.1079/bjn20041383.
- Hur H, Si Y, Kang WK, Kim W, Jeon HM. Effects of early oral feeding on surgical outcomes and recovery after curative surgery for gastric cancer: pilot study results. World J Surg. 2009 Jul;33(7):1454-8. doi: 10.1007/s00268-009-0009-3.
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
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