Multimodal Prehabilitation for Tumor-Related Bowel Obstruction
2026年8月14日 更新者：The Affiliated Hospital of Qingdao University
Effect of Multimodal Prehabilitation on Clinical Outcomes in Patients With Tumor-Related Bowel Obstruction: A Multicenter Randomized Controlled Trial
The goal of this clinical trial is to establish a multimodal prehabilitation protocol suitable for patients with tumor-related bowel obstruction during the perioperative period, and to explore its safety and efficacy; to evaluate the impact of this protocol on short-term and long-term clinical outcomes and recovery indicators.The participants will be divided into two groups.
The experimental group will receive an integrated program of preoperative multi-modal pre-rehabilitation intervention combined with postoperative immune nutrition support; the control group will receive traditional perioperative management for intestinal obstruction.
調査の概要
状態
まだ募集していません
条件
研究の種類
介入
入学 (推定)
394
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Yanbing Zhou, MD
- 電話番号：86532-82911324
- メール：zhouyanbing@qduhospital.cn
研究場所
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Shandong
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Qingdao、Shandong、中国、266003
- Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital, Qingdao, Shandong 266000
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Inclusion Criteria:
- Pathologically/cytologically confirmed malignant tumor (including digestive system and gynecological origin tumors); or imaging data suggesting tumor space-occupying lesions combined with multiple metastatic foci;
- Diagnosis of bowel obstruction (complete or incomplete) confirmed by medical history, symptoms, signs, and imaging (abdominal plain film/CT), and after MDT decision-making, no emergency surgery is required, short-term conservative treatment has potential for remission, and the expected interval from conservative treatment period to planned surgery is ≥7 days;
- Age between 18 and 85 years;
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
- Expected survival ≥12 weeks;
- Patients and their families have full understanding of disease progression and prognosis, accept conservative treatment, and are fully mentally prepared for the high incidence of severe surgical complications; they can understand and voluntarily sign the written informed consent form, which must be signed before performing study-specified procedures.
Exclusion Criteria:
- Presence of acute, life-threatening complications such as strangulated bowel obstruction, electrolyte disturbances, or sepsis;
- Presence of intestinal necrosis, perforation, bleeding, or other conditions requiring immediate surgical treatment;
- ASA grade >IV, severe cardiac insufficiency (preoperative LVEF <30% or NYHA grade IV), severe hepatic dysfunction (Child-Pugh grade C), and renal dysfunction (requiring CRRT);
- History of cerebral hemorrhage, cerebral infarction, TIA, or presence of central nervous system disease, psychiatric disease, or bedridden status within 6 months before informed consent that precludes completion of multimodal intervention;
- Long-term or high-dose use of immunosuppressants or glucocorticoids within 1 month before enrollment;
- Presence of language communication barriers, unable to independently or with family assistance understand and complete intervention and assessment;
- Patients currently participating in other drug or clinical interventional trials.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：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：Experimental group
The experimental group: on the basis of the standard six-step treatment model (decompression, adding nutrition, suppressing digestive fluid secretion, hormone, diuresis, and exercise and promoting intestinal peristalsis), a goal-directed multimodal prehabilitation intervention lasting 5 to 7 days will be superimposed and implemented during the preoperative hospitalization period, with contents including immunonutritional support, progressive physical training, and structured psychological counseling.
Postoperatively, the standard perioperative Enhanced Recovery After Surgery (ERAS) protocol will be continued to be executed, and immunonutritional treatment will be strengthened.
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その中心的な内容は、患者の生理学的および心理的ストレスを軽減し、回復を促進するために、証拠に基づいた医学的知見に基づいて周術期に実行される一連の最適化された措置を採用することです。
Multimodal prehabilitation program adopts a planned, structured, repeatable, and purposeful approach, encompassing exercise, nutrition, and psychological factors.
The standard six-step treatment protocol refers to: decompression, nutritional supplementation, suppression of digestive fluid secretion, hormone therapy, diuresis, exercise, and promotion of intestinal peristalsis.
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アクティブコンパレータ：Control group
The control group: preoperatively, only the standard six-step treatment protocol will be received.
Postoperatively, standard Enhanced Recovery After Surgery (ERAS) protocol will be followed for perioperative management.
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その中心的な内容は、患者の生理学的および心理的ストレスを軽減し、回復を促進するために、証拠に基づいた医学的知見に基づいて周術期に実行される一連の最適化された措置を採用することです。
The standard six-step treatment protocol refers to: decompression, nutritional supplementation, suppression of digestive fluid secretion, hormone therapy, diuresis, exercise, and promotion of intestinal peristalsis.
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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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Comprehensive Complication Index (CCI)
時間枠：Postoperative (≤30 days after surgery)
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Used to quantify the cumulative complication burden of individual patients.
The calculation premise is to first grade each complication occurring within 30 days postoperatively according to the Clavien-Dindo Classification (CDC), then accumulate the corresponding "weight (wC)" of each complication, substitute into the formula for square root calculation and divide by 2, ultimately obtaining a continuous score from 0-100 (0 = no complications, 100 = death).
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Postoperative (≤30 days after surgery)
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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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The 30-day postoperative mortality
時間枠：POD 30（30 days after surgery）
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30-day postoperative mortality defined as death within 30 days postoperatively or in-hospital death during hospitalization.
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POD 30（30 days after surgery）
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Complication occurrence during the preoperative observation and intervention period, remission rate of bowel obstruction after conservative treatment
時間枠：Baseline (T0), Post-intervention (At least 7 days),
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The complication occurrence defined as complications diagnosed after admission and occurring before surgery
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Baseline (T0), Post-intervention (At least 7 days),
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Preoperative and 30-day postoperative quality of life scores
時間枠：Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
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Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
The questionnaire assesses 15 dimensions of HRQoL, including physical, psychological, and social functions.
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Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
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Nutritional status-hemoglobin, albumin, prealbumin levels
時間枠：Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, 30
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Hemoglobin, albumin, and prealbumin levels are used to assess nutritional status.
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Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, 30
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Immune status - CRP, NLR, CD4/CD8
時間枠：Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, and 30.
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Inflammatory indicators, including C-reactive protein (CRP), the neutrophil-to-lymphocyte ratio (NLR), and CD4/CD8, can reflect the level of inflammation.
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Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, and 30.
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Functional capacity
時間枠：Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
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preoperative and 30-day postoperative 6-Minute Walk Test
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Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
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postoperative ICU stay
時間枠：POD 30（30 days after surgery）
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Duration of postoperative ICU stay (hours), defined as time to transfer to icu for treatment after surgery.
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POD 30（30 days after surgery）
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The incidence and severity of complications within 30 days after the surgery
時間枠：POD 30（30 days after surgery）
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Incidence and severity of complications within 30 days postoperatively (especially infectious complications) (all complications will be scored according to the Clavien-Dindo classification system)
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POD 30（30 days after surgery）
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Preoperative and 30-day postoperative psychological states
時間枠：Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
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Psychological states was measured by Hospital Anxiety and Depression Scale (HADS).
Higher scores indicate more severe anxiety or depression symptoms.
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Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
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mechanical ventilation time
時間枠：POD 30（30 days after surgery）
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POD 30（30 days after surgery）
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postoperative pain severity
時間枠：POD 30（30 days after surgery）
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The severity of postoperative pain is evaluated using the Visual Analog Scale for pain (VAS, 0 = no pain, 10 = most severe pain).
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POD 30（30 days after surgery）
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total hospitalization costs
時間枠：POD 30（30 days after surgery）
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POD 30（30 days after surgery）
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2028年7月1日
研究の完了 (推定)
2028年8月1日
試験登録日
最初に提出
2026年8月11日
QC基準を満たした最初の提出物
2026年8月14日
最初の投稿 (実際)
2026年8月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月17日
QC基準を満たした最後の更新が送信されました
2026年8月14日
最終確認日
2026年8月1日
詳しくは
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- GISSG-PREHAB2602
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