PROPOSAL FOR A PREOPERATIVE FUNCTIONAL OPTIMIZATION PATHWAY FOR PATIENTS CANDIDATE FOR MAJOR SURGERY (CARDIAC AND ABDOMINAL ONCOLOGY) (PRIME CARE)
PRehabilitation With Integrated and Multimodal Evaluation in Cardiac and Abdominal majoR surgEry (PRIME CARE) A Proposed Pathway for Preoperative Functional Optimization in Candidates for Major Surgery
The study aims to evaluate a prehabilitation protocol for patients undergoing cardiac and abdominal surgery. The project for a preparation program for cardiac surgery was developed within the framework of ERAS (Enhanced Recovery After Surgery), which aims to ensure optimal recovery after surgery and a Surgery), which aims to ensure optimal recovery after surgery and an early and safe return to daily activities.
The study focuses on the preoperative phase, with the introduction of the concept of prehabilitation, i.e., a program to enhance the functional abilities of individuals in preparation for major surgery. The study focuses on the preoperative phase, introducing the concept of prehabilitation, i.e., a program to enhance the functional abilities of individuals in preparation for major surgery, such as cardiac surgery, on an elective basis.
This program, which currently represents best clinical practice, lasts four weeks and addresses several areas: strengthening respiratory and muscular functions, optimizing nutrition, and cognitive stimulation. Patients will be assessed at enrollment and up to 180 days post-surgery to evaluate their clinical status compared to pre-surgery on these four aspects mentioned above.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Massimo Stella, MD
- Número de teléfono: 0039 0332393447
- Correo electrónico: maxstella95@gmail.com
Ubicaciones de estudio
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Varese, Italia, 21100
- Activo, no reclutando
- ASST Sette Laghi
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VA
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Varese, VA, Italia, 21052
- Reclutamiento
- Ospedale di Circolo
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Contacto:
- Massimo Stella, MD
- Número de teléfono: +39 0332 393447
- Correo electrónico: maxstella95@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
This prospective, observational, single-center study will enroll approximately 50 adult patients (≥18 years old) undergoing elective cardiac or major abdominal surgery at Ospedale di Circolo e Fondazione Macchi, Varese, Italy. Eligible patients for abdominal surgery must have ASA I-III and PS ECOG ≤2. Key exclusion criteria include emergency surgery, unstable angina, malignant arrhythmias, severe or very severe COPD, dementia, pregnancy, or inability to provide informed consent. Participants will be screened by the surgical team and followed during a personalized prehabilitation program starting about one month before surgery.
Descripción
Inclusion Criteria:
- Elective major abdominal surgery or elective cardio surgery
- American Society of Anaesthesiologists Physical Status Classification ≤ 3
- Performance Status according to ECOG Scale ≤ 2
Exclusion Criteria:
- Emergency surgery
- Unstable angina
- Malignant arrythmias
- Severe/ very severe COPD
- Dementia
- Pregnancy
- Inability to provide informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: CASE_ONLY
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
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Eligible patients for major surgery
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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10% improvement from baseline at 6-minutes-walking-test-distance
Periodo de tiempo: From enrollment to the date of surgery
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The primary outcome of this study is to evaluate whether prehabilitation translates into an improvement in quality of life before surgery, assessed in terms of functional status. This objective is assessed using the 6-minute walking distance test. A significant improvement is considered to be a positive delta in the six-minute walking test of ≥10% obtained at the assessment performed on the day of admission compared to the value recorded during the first assessment. |
From enrollment to the date of surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Increased thickness of the quadriceps femoris muscle
Periodo de tiempo: From enrollment to the date of surgery
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An increase in the thickness of the quadriceps femoris muscle will be assessed via ultrasound as a direct sign of an increase in the number and volume of muscle fibres |
From enrollment to the date of surgery
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Increased cross-sectional area of the quadriceps femoris muscle
Periodo de tiempo: From enrollment to the date of surgery
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An increase in the cross-sectional area of the quadriceps femoris muscle will be assessed via ultrasound as a direct sign of an increase in the number and volume of muscle fibres |
From enrollment to the date of surgery
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Increased pennation angle of the quadriceps femoris muscle
Periodo de tiempo: From enrollment to the date of surgery
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An increase in the pennation angle of the quadriceps femoris muscle, assessed by ultrasound, is a direct sign of increased contractility of the muscle itself, and therefore an indirect index of an increase in muscle strength. |
From enrollment to the date of surgery
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Change in Pulmonary Function Parameters
Periodo de tiempo: From enrollment to the date of surgery
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Change in pulmonary volumes including Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), and Tiffeneau Index (FEV1/FVC ratio) measured through spirometry at baseline and after completion of prehabilitation. |
From enrollment to the date of surgery
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Improvement in Functional Performance Tests
Periodo de tiempo: From enrollment to the date of surgery
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Change in performance at Handgrip Strength test (Newton), and Maximal Isometric Strength test (Newton), assessed at baseline and after the prehabilitation program. An increase in the value indicates an improvement in functional capacity. |
From enrollment to the date of surgery
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Change in Diaphragmatic Excursion
Periodo de tiempo: From enrollment to the date of surgery
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Variation in diaphragmatic movement amplitude assessed by ultrasound before and after the prehabilitation period. |
From enrollment to the date of surgery
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Change in Health-Related Quality of Life (EQ-5D-5L Index)
Periodo de tiempo: From enrollment to 180 days after discharge
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Variation in patient-reported quality of life as assessed by the EQ-5D-5L questionnaire. The index score will be compared between baseline and preoperative assessment after prehabilitation and also at 30 days and 180days after discharge |
From enrollment to 180 days after discharge
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Incidence of Postoperative Delirium in the Intensive Care Unit
Periodo de tiempo: Perioperative/Periprocedural
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Occurrence of postoperative delirium evaluated daily during ICU stay using the Confusion Assessment Method for the ICU (CAM-ICU). |
Perioperative/Periprocedural
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Change in Nutritional and Biochemical Markers
Periodo de tiempo: From enrollment to 30 days after discharge
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Variation in nutritional status indicators assessed through blood biochemical parameters (albumin, prealbumin, total protein, lymphocyte count, iron, transferrin, vitamin B12, folic acid, hemoglobin,) before the prehabilitation program, after the prehabilitation program and at 30 days after discharge |
From enrollment to 30 days after discharge
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Length of Stay in Intensive Care Unit
Periodo de tiempo: Perioperative/Periprocedural
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Duration of ICU stay (in days) from postoperative admission to ICU discharge. |
Perioperative/Periprocedural
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Total Hospital Length of Stay
Periodo de tiempo: Perioperative/Periprocedural
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Total duration of hospitalization (in days) from admission for surgery to hospital discharge. |
Perioperative/Periprocedural
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180-Day Mortality
Periodo de tiempo: From discharge to 180 days after surgery
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All-cause mortality evaluated at 180 days after surgery. |
From discharge to 180 days after surgery
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 25/2025
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
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