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

25. září 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Typ studie

Pozorovací

Zápis (Odhadovaný)

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Jméno: Massimo Stella, MD
Telefonní číslo: 0039 0332393447
E-mail: maxstella95@gmail.com

Studijní místa

Itálie
- - Varese, Itálie, 21100
    - Aktivní, ne nábor
    - ASST Sette Laghi
- VA
  - Varese, VA, Itálie, 21052
    - Nábor
    - Ospedale di Circolo
    - Kontakt:
      
      Massimo Stella, MD
      
      Telefonní číslo: +39 0332 393447
      
      E-mail: maxstella95@gmail.com

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Observační modely: CASE_ONLY
Časové perspektivy: PROSPECTIVE

Počet skupin / kohort

Kohorty a intervence

Skupina / kohorta
Eligible patients for major surgery

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
10% improvement from baseline at 6-minutes-walking-test-distance Časové okno: 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

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Increased thickness of the quadriceps femoris muscle Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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) Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: Perioperative/Periprocedural	Duration of ICU stay (in days) from postoperative admission to ICU discharge.	Perioperative/Periprocedural
Total Hospital Length of Stay Časové okno: Perioperative/Periprocedural	Total duration of hospitalization (in days) from admission for surgery to hospital discharge.	Perioperative/Periprocedural
180-Day Mortality Časové okno: From discharge to 180 days after surgery	All-cause mortality evaluated at 180 days after surgery.	From discharge to 180 days after surgery

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

ASST Sette Laghi

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

29. července 2026

Primární dokončení (Odhadovaný)

31. července 2028

Dokončení studie (Odhadovaný)

30. listopadu 2028

Termíny zápisu do studia

První předloženo

18. února 2026

První předloženo, které splnilo kritéria kontroly kvality

25. září 2026

První zveřejněno (Aktuální)

1. října 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)