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PROPOSAL FOR A PREOPERATIVE FUNCTIONAL OPTIMIZATION PATHWAY FOR PATIENTS CANDIDATE FOR MAJOR SURGERY (CARDIAC AND ABDOMINAL ONCOLOGY) (PRIME CARE)

25 de setembro de 2026 atualizado por: Luca Guzzetti, ASST Sette Laghi

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.

Visão geral do estudo

Status

Recrutamento

Condições

Tipo de estudo

Observacional

Inscrição (Estimado)

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: Massimo Stella, MD
Número de telefone: 0039 0332393447
E-mail: maxstella95@gmail.com

Locais de estudo

Itália
- - Varese, Itália, 21100
    - Ativo, não recrutando
    - ASST Sette Laghi
- VA
  - Varese, VA, Itália, 21052
    - Recrutamento
    - Ospedale di Circolo
    - Contato:
      
      Massimo Stella, MD
      
      Número de telefone: +39 0332 393447
      
      E-mail: maxstella95@gmail.com

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

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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

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

Modelos de observação: CASE_ONLY
Perspectivas de Tempo: PROSPECTIVE

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
Eligible patients for major surgery

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
10% improvement from baseline at 6-minutes-walking-test-distance Prazo: From enrollment to the date of surgery	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

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Increased thickness of the quadriceps femoris muscle Prazo: From enrollment to the date of surgery	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
Increased cross-sectional area of the quadriceps femoris muscle Prazo: From enrollment to the date of surgery	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
Increased pennation angle of the quadriceps femoris muscle Prazo: From enrollment to the date of surgery	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
Change in Pulmonary Function Parameters Prazo: From enrollment to the date of surgery	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
Improvement in Functional Performance Tests Prazo: From enrollment to the date of surgery	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
Change in Diaphragmatic Excursion Prazo: From enrollment to the date of surgery	Variation in diaphragmatic movement amplitude assessed by ultrasound before and after the prehabilitation period.	From enrollment to the date of surgery
Change in Health-Related Quality of Life (EQ-5D-5L Index) Prazo: From enrollment to 180 days after discharge	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
Incidence of Postoperative Delirium in the Intensive Care Unit Prazo: Perioperative/Periprocedural	Occurrence of postoperative delirium evaluated daily during ICU stay using the Confusion Assessment Method for the ICU (CAM-ICU).	Perioperative/Periprocedural
Change in Nutritional and Biochemical Markers Prazo: From enrollment to 30 days after discharge	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
Length of Stay in Intensive Care Unit Prazo: Perioperative/Periprocedural	Duration of ICU stay (in days) from postoperative admission to ICU discharge.	Perioperative/Periprocedural
Total Hospital Length of Stay Prazo: Perioperative/Periprocedural	Total duration of hospitalization (in days) from admission for surgery to hospital discharge.	Perioperative/Periprocedural
180-Day Mortality Prazo: From discharge to 180 days after surgery	All-cause mortality evaluated at 180 days after surgery.	From discharge to 180 days after surgery

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

ASST Sette Laghi

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 (Real)

29 de julho de 2026

Conclusão Primária (Estimado)

31 de julho de 2028

Conclusão do estudo (Estimado)

30 de novembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

18 de fevereiro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de setembro de 2026

Primeira postagem (Real)

1 de outubro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)