- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07767760
Multimodal Prehabilitation for Tumor-Related Bowel Obstruction
14 de agosto de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
394
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Yanbing Zhou, MD
- Número de teléfono: 86532-82911324
- Correo electrónico: zhouyanbing@qduhospital.cn
Ubicaciones de estudio
-
-
Shandong
-
Qingdao, Shandong, Porcelana, 266003
- Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital, Qingdao, Shandong 266000
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
El contenido principal es adoptar una serie de medidas optimizadas realizadas durante el período perioperatorio sobre la base de hallazgos médicos basados en evidencia para reducir el estrés fisiológico y psicológico de los pacientes y acelerar su recuperación.
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.
|
|
Comparador activo: 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.
|
El contenido principal es adoptar una serie de medidas optimizadas realizadas durante el período perioperatorio sobre la base de hallazgos médicos basados en evidencia para reducir el estrés fisiológico y psicológico de los pacientes y acelerar su recuperación.
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Comprehensive Complication Index (CCI)
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The 30-day postoperative mortality
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: POD 30(30 days after surgery)
|
POD 30(30 days after surgery)
|
|
|
postoperative pain severity
Periodo de tiempo: 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
Periodo de tiempo: POD 30(30 days after surgery)
|
POD 30(30 days after surgery)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
1 de julio de 2028
Finalización del estudio (Estimado)
1 de agosto de 2028
Fechas de registro del estudio
Enviado por primera vez
11 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
14 de agosto de 2026
Publicado por primera vez (Actual)
17 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
14 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GISSG-PREHAB2602
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .