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

25 września 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Nazwa: Massimo Stella, MD
Numer telefonu: 0039 0332393447
E-mail: maxstella95@gmail.com

Lokalizacje studiów

Włochy
- - Varese, Włochy, 21100
    - Aktywny, nie rekrutujący
    - ASST Sette Laghi
- VA
  - Varese, VA, Włochy, 21052
    - Rekrutacyjny
    - Ospedale di Circolo
    - Kontakt:
      
      Massimo Stella, MD
      
      Numer telefonu: +39 0332 393447
      
      E-mail: maxstella95@gmail.com

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Modele obserwacyjne: CASE_ONLY
Perspektywy czasowe: PROSPECTIVE

Liczba grup / kohort

Kohorty i interwencje

Grupa / Kohorta
Eligible patients for major surgery

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
10% improvement from baseline at 6-minutes-walking-test-distance Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Increased thickness of the quadriceps femoris muscle Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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) Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: Perioperative/Periprocedural	Duration of ICU stay (in days) from postoperative admission to ICU discharge.	Perioperative/Periprocedural
Total Hospital Length of Stay Ramy czasowe: Perioperative/Periprocedural	Total duration of hospitalization (in days) from admission for surgery to hospital discharge.	Perioperative/Periprocedural
180-Day Mortality Ramy czasowe: From discharge to 180 days after surgery	All-cause mortality evaluated at 180 days after surgery.	From discharge to 180 days after surgery

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

ASST Sette Laghi

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

29 lipca 2026

Zakończenie podstawowe (Szacowany)

31 lipca 2028

Ukończenie studiów (Szacowany)

30 listopada 2028

Daty rejestracji na studia

Pierwszy przesłany

18 lutego 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

25 września 2026

Pierwszy wysłany (Rzeczywisty)

1 października 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)