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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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

394

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Shandong
      • Qingdao、Shandong、中国、266003
        • Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital, Qingdao, Shandong 266000

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. 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;
  2. 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;
  3. Age between 18 and 85 years;
  4. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
  5. Expected survival ≥12 weeks;
  6. 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:

  1. Presence of acute, life-threatening complications such as strangulated bowel obstruction, electrolyte disturbances, or sepsis;
  2. Presence of intestinal necrosis, perforation, bleeding, or other conditions requiring immediate surgical treatment;
  3. 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);
  4. 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;
  5. Long-term or high-dose use of immunosuppressants or glucocorticoids within 1 month before enrollment;
  6. Presence of language communication barriers, unable to independently or with family assistance understand and complete intervention and assessment;
  7. Patients currently participating in other drug or clinical interventional trials.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
行为的：ERAS协议
其核心内容是在循证医学发现的基础上，在围手术期采取一系列优化措施，减轻患者的生理和心理压力，加速患者康复。
行为的：Multimodal prehabilitation program
Multimodal prehabilitation program adopts a planned, structured, repeatable, and purposeful approach, encompassing exercise, nutrition, and psychological factors.
行为的：Standard six-step treatment
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.
有源比较器：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.
行为的：ERAS协议
其核心内容是在循证医学发现的基础上，在围手术期采取一系列优化措施，减轻患者的生理和心理压力，加速患者康复。
行为的：Standard six-step treatment
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Comprehensive Complication Index (CCI)
大体时间：Postoperative (≤30 days after surgery)
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).
Postoperative (≤30 days after surgery)

次要结果测量

结果测量
措施说明
大体时间
The 30-day postoperative mortality
大体时间：POD 30（30 days after surgery）
30-day postoperative mortality defined as death within 30 days postoperatively or in-hospital death during hospitalization.
POD 30（30 days after surgery）
Complication occurrence during the preoperative observation and intervention period, remission rate of bowel obstruction after conservative treatment
大体时间：Baseline (T0), Post-intervention (At least 7 days),
The complication occurrence defined as complications diagnosed after admission and occurring before surgery
Baseline (T0), Post-intervention (At least 7 days),
Preoperative and 30-day postoperative quality of life scores
大体时间：Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
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.
Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
Nutritional status-hemoglobin, albumin, prealbumin levels
大体时间：Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, 30
Hemoglobin, albumin, and prealbumin levels are used to assess nutritional status.
Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, 30
Immune status - CRP, NLR, CD4/CD8
大体时间：Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, and 30.
Inflammatory indicators, including C-reactive protein (CRP), the neutrophil-to-lymphocyte ratio (NLR), and CD4/CD8, can reflect the level of inflammation.
Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, and 30.
Functional capacity
大体时间：Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
preoperative and 30-day postoperative 6-Minute Walk Test
Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
postoperative ICU stay
大体时间：POD 30（30 days after surgery）
Duration of postoperative ICU stay (hours), defined as time to transfer to icu for treatment after surgery.
POD 30（30 days after surgery）
The incidence and severity of complications within 30 days after the surgery
大体时间：POD 30（30 days after surgery）
Incidence and severity of complications within 30 days postoperatively (especially infectious complications) (all complications will be scored according to the Clavien-Dindo classification system)
POD 30（30 days after surgery）
Preoperative and 30-day postoperative psychological states
大体时间：Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
Psychological states was measured by Hospital Anxiety and Depression Scale (HADS). Higher scores indicate more severe anxiety or depression symptoms.
Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
mechanical ventilation time
大体时间：POD 30（30 days after surgery）
POD 30（30 days after surgery）
postoperative pain severity
大体时间：POD 30（30 days after surgery）
The severity of postoperative pain is evaluated using the Visual Analog Scale for pain (VAS, 0 = no pain, 10 = most severe pain).
POD 30（30 days after surgery）
total hospitalization costs
大体时间：POD 30（30 days after surgery）
POD 30（30 days after surgery）

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The Affiliated Hospital of Qingdao University

合作者

Peking University People's Hospital
Fudan University
Fujian Medical University Union Hospital
The Second Hospital of Shandong University
Yantai Yuhuangding Hospital
Xinjiang Medical University
Weifang People's Hospital
Rizhao People's Hospital
The First School of Clinical Medicine of Binzhou Medical University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2028年7月1日

研究完成 (估计的)

2028年8月1日

研究注册日期

首次提交

2026年8月11日

首先提交符合 QC 标准的

2026年8月14日

首次发布 (实际的)

2026年8月17日

研究记录更新

最后更新发布 (实际的)

2026年8月17日

上次提交的符合 QC 标准的更新

2026年8月14日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • GISSG-PREHAB2602

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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