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el efecto de la prehabilitación con nutrición optimizada sobre la intervención perioperatoria en el carcinoma hepatocelular primario

Impacto de la prehabilitación con nutrición optimizada en los resultados perioperatorios en el carcinoma hepatocelular primario: un ensayo controlado aleatorio

This study aimed to evaluate whether nutritional optimization-led triple prehabilitation could improve perioperative nutritional status, promote postoperative recovery, and reduce postoperative complications in patients with primary liver cancer undergoing surgery. After screening according to the inclusion and exclusion criteria, eligible patients were randomized into experimental and control groups. Both groups received exercise and psychological interventions; for nutritional intervention, the experimental group received an ordinary diet plus oral nutritional supplementation, whereas the control group received an ordinary diet alone. Routine clinical blood tests were performed at the time of enrollment and on the first, third and fifth days after surgery. Enrolled patients were followed up by telephone or outpatient clinic at 1 month postoperatively.

Descripción general del estudio

Descripción detallada

Study subgroups: experimental group (nutritional optimization-led triple prehabilitation), control group (conventional triple prehabilitation) , with a 1:2 allocation ratio between experimental and control groups.

Intervention measures The nutritional status of each participant will be assessed in collaboration with a clinical nutritionist to develop an individualized nutritional plan. The experimental group will receive oral nutritional supplementation (ONS; Ensure) in addition to their usual diet, whereas the control group will receive their usual diet alone.

Resting energy expenditure (REE) will be estimated using the revised Harris-Benedict equations:

Men: REE (kcal/day) = 88.362 + 13.397W + 4.799H - 5.677A Women: REE (kcal/day) = 447.593 + 9.247W + 3.098H - 4.330A where W is body weight (kg), H is height (cm), and A is age (years). The estimated daily energy requirement will be calculated as REE * 1.3 (activity factor) * 1.2 (stress factor). Assuming a usual dietary energy intake of approximately 1,600 kcal/day, the additional energy to be supplied by ONS will be calculated by subtracting 1,600 kcal from the estimated daily energy requirement. Ensure powder provides 4.50 kcal/g; therefore, the required daily amount of powder will be calculated by dividing the additional energy requirement by 4.50 kcal/g.

The calculated daily amount of Ensure powder will be divided into three doses, each dissolved in 200 mL of warm water and taken orally between meals. Adherence will be monitored by the nursing team and clinical nutritionist, who will record actual supplement intake. The intervention will begin at enrollment and continue until the day before surgery.

Other interventions:

A personalized exercise program will be developed with the rehabilitation physician, and both groups will undergo exercise to increase lung capacity and cardiorespiratory tolerance: respiratory exercise will be included - patients will be guided to learn to cough and cough up sputum with deep breaths before the operation, and a respiratory trainer will be used for bedside training.

Exercise planning: in addition to respiratory training, patients will perform aerobic exercise (jogging or walking) and resistance exercise (dumbbells or resistance bands), with intensity and frequency individualized according to baseline fitness.

The experimental and control groups will undergo psychiatric intervention: patients will be psychologically evaluated with the Hospital Anxiety and Depression Scale (HADS), together with the Fatigue Assessment Scale (FAS). Those with elevated anxiety or depression (HADS ≥ 11) will receive psychological counseling 3-5 times during the preoperative week and medication when necessary, and will be guided to listen to soothing music for at least 15 minutes before bedtime daily.

The patients will undergo routine clinical blood tests at the time of enrollment and the 1st, 3rd and 5th days after the operation.

Follow-up The patients will be followed up by telephone or outpatient clinic at 1 month after the operation; the patients' clinical data will be recorded.

The relevant clinical data during the process will be recorded.

Tipo de estudio

Intervencionista

Inscripción (Actual)

132

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.

Ubicaciones de estudio

    • Jiangxi
      • Shangrao, Jiangxi, Porcelana, 334000
        • ShangRao People's Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, Porcelana, 310009
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
      • Huzhou, Zhejiang, Porcelana, 313000
        • Huzhou Central Hospital

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

18 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patients diagnosed with primary liver cancer.

    • Patients between the ages of 18 and 80.

      • Patients who are feasible for surgical treatment after clinical evaluation.

Exclusion Criteria:

  • Patients with liver metastases or combined with other tumors.

    • Patients with allergy to the ingredients of nutritional preparations. ③Patients with severe malnutrition who cannot eat by mouth. ④Patients with hyperthyroidism, fistula, and combined digestive system diseases.

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: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Nutritional optimization-led triple prehabilitation Intervention

Nutritional optimization-led triple prehabilitation

The nutritional status of the patients was assessed together with the clinical nutritionist to develop an individualized nutritional plan. The experimental group used ordinary dietary supplementation + oral nutritional supplementation, and the control group used ordinary dietary supplementation. The target energy was calculated as resting energy expenditure (REE, revised Harris-Benedict [Shizgal-Rosa] equation) × 1.3 (activity factor) × 1.2 (stress factor), and the oral nutritional supplement dose was (target energy - 1,600 kcal) ÷ 4.50 kcal/g. Exercise workouts focused on increasing lung capacity and cardiorespiratory tolerance. Specialized psychological interventions.

Otro: Conventional triple prehabilitation Intervention

Conventional triple prehabilitation

Conventional triple prehabilitation: ordinary dietary supplementation; exercise workouts focused on increasing lung capacity and cardiorespiratory tolerance; specialized psychological interventions.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in serum prealbumin concentration from baseline to postoperative day 1
Periodo de tiempo: From baseline to postoperative day 1

peripheral blood

From baseline to postoperative day 1

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
6-minute walk distance (meters)
Periodo de tiempo: One week after surgery

walk test for six minutes(6MWT)

One week after surgery
Postoperative serum prealbumin Concentration
Periodo de tiempo: One day after surgery

peripheral blood

One day after surgery
Postoperative Serum Albumin Concentration
Periodo de tiempo: One day after surgery

peripheral blood

One day after surgery
Postoperative Serum Retinol-Binding Protein Concentration
Periodo de tiempo: One day after surgery

peripheral blood

One day after surgery

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Silla de estudio: Yuan Ding, Second Affiliated Hospital, Zhejiang University, School of Medicine

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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 (Actual)

10 de mayo de 2024

Finalización primaria (Actual)

1 de septiembre de 2026

Finalización del estudio (Actual)

29 de septiembre de 2026

Fechas de registro del estudio

Enviado por primera vez

13 de mayo de 2024

Primero enviado que cumplió con los criterios de control de calidad

8 de agosto de 2024

Publicado por primera vez (Actual)

12 de agosto de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de noviembre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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. .

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