Combined Oral and Parenteral Nutritional Therapy After Gastrectomy for Gastric Cancer (BRIDGE-GC)
Bridging the Postoperative Nutritional Gap After Gastrectomy for Gastric Cancer: A Prospective Randomized Trial of Combined Oral and Parenteral Nutritional Therapy
Patients undergoing gastrectomy for gastric cancer frequently experience insufficient oral intake during the postoperative recovery period because of reduced gastric capacity, early satiety, and gastrointestinal symptoms. Although oral nutritional supplements (ONS) are commonly recommended, adherence is often poor, resulting in a postoperative nutritional gap.
This prospective randomized clinical trial was designed to evaluate the impact of combined oral and parenteral nutritional therapy on nutritional status and recovery after gastrectomy for gastric cancer. Patients were randomized to either a combined nutritional therapy group receiving oral nutritional supplementation plus parenteral nutrition or a control group receiving standard postoperative care.
The primary endpoint was postoperative body weight change at 4 weeks after surgery. Secondary endpoints included body composition, nutritional intake, inflammatory and immune markers, laboratory parameters, and quality of life outcomes.
調査の概要
状態
詳細な説明
Postoperative nutritional deterioration remains a major clinical challenge after gastrectomy for gastric cancer. Reduced gastric capacity and postoperative gastrointestinal symptoms frequently result in inadequate oral intake during the early recovery period. Although oral nutritional supplements are widely recommended, adherence is often poor, potentially leading to insufficient caloric intake and postoperative nutritional deficits.
This prospective randomized clinical trial evaluates whether combined oral and parenteral nutritional therapy can improve postoperative nutritional status and recovery compared with standard postoperative care. Patients undergoing curative gastrectomy for gastric cancer are randomized to receive either combined oral nutritional supplementation plus parenteral nutrition or standard postoperative nutritional management.
Nutritional outcomes including body weight, body mass index, body composition, inflammatory markers, laboratory nutritional parameters, caloric intake, oral nutritional supplement adherence, and quality of life are assessed during the postoperative recovery period.
This study aims to clarify the clinical significance of supplemental parenteral nutrition in bridging the postoperative nutritional gap after gastrectomy.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Seoul
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Seoul、Seoul、韓国、06591
- Seoul St. Mary'S Hospital
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 20 to 80 years
- Histologically confirmed gastric cancer
- Scheduled for curative total or subtotal gastrectomy
- Ability to tolerate oral intake
- Residence within areas covered by home care services
- Written informed consent
Exclusion Criteria:
- Body mass index (BMI) ≥30 kg/m² or <18.5 kg/m²
- Uncontrolled diabetes mellitus
- Severe hepatic or renal dysfunction
- Active malignancy other than gastric cancer
- Previous chemotherapy or radiotherapy
- Allergy to oral nutritional supplement products
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：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：Combined Nutritional Therapy
Patients received combined oral nutritional supplementation and parenteral nutritional support during the postoperative recovery period after gastrectomy for gastric cancer.
|
Patients received oral nutritional supplementation using Encover® three times daily during the postoperative recovery period after gastrectomy for gastric cancer.
Supplemental parenteral nutrition was administered during hospitalization and after discharge to support postoperative nutritional requirements.
|
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アクティブコンパレータ：Standard Postoperative Care
Patients received standard postoperative nutritional management according to institutional clinical pathways after gastrectomy for gastric cancer.
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Standard postoperative nutritional management according to institutional clinical pathways, including routine postoperative diet advancement and conventional nutritional support.
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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 Body Weight Change
時間枠：4 weeks after surgery
|
Difference between preoperative body weight and body weight measured at 4 weeks after gastrectomy for gastric cancer.
|
4 weeks after surgery
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Body Mass Index Change
時間枠：4 weeks after surgery
|
4 weeks after surgery
|
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 (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 (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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- XC17MCDI0065
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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