Multimodal Prehabilitation for Tumor-Related Bowel Obstruction
14 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Tipo de estudo
Intervencional
Inscrição (Estimado)
394
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Yanbing Zhou, MD
- Número de telefone: 86532-82911324
- E-mail: zhouyanbing@qduhospital.cn
Locais de estudo
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Shandong
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Qingdao, Shandong, China, 266003
- Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital, Qingdao, Shandong 266000
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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O conteúdo principal é adotar uma série de medidas otimizadas realizadas durante o período perioperatório com base em descobertas médicas baseadas em evidências para reduzir o estresse fisiológico e psicológico dos pacientes e acelerar sua recuperação.
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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Comparador Ativo: 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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O conteúdo principal é adotar uma série de medidas otimizadas realizadas durante o período perioperatório com base em descobertas médicas baseadas em evidências para reduzir o estresse fisiológico e psicológico dos pacientes e acelerar sua recuperação.
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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Comprehensive Complication Index (CCI)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The 30-day postoperative mortality
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: POD 30（30 days after surgery）
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POD 30（30 days after surgery）
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postoperative pain severity
Prazo: 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
Prazo: POD 30（30 days after surgery）
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POD 30（30 days after surgery）
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de agosto de 2026
Conclusão Primária (Estimado)
1 de julho de 2028
Conclusão do estudo (Estimado)
1 de agosto de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
11 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de agosto de 2026
Primeira postagem (Real)
17 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- GISSG-PREHAB2602
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
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Não
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