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

25 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Studietyp

Observationell

Inskrivning (Beräknad)

50

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Italien
      • Varese, Italien, 21100
        • Aktiv, inte rekryterande
        • ASST Sette Laghi
    • VA
      • Varese, VA, Italien, 21052
        • Rekrytering
        • Ospedale di Circolo
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: CASE_ONLY
  • Tidsperspektiv: PROSPECTIVE

Kohorter och interventioner

Grupp / Kohort
Eligible patients for major surgery

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
10% improvement from baseline at 6-minutes-walking-test-distance
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Increased thickness of the quadriceps femoris muscle
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Perioperative/Periprocedural

Duration of ICU stay (in days) from postoperative admission to ICU discharge.
Perioperative/Periprocedural
Total Hospital Length of Stay
Tidsram: Perioperative/Periprocedural

Total duration of hospitalization (in days) from admission for surgery to hospital discharge.
Perioperative/Periprocedural
180-Day Mortality
Tidsram: From discharge to 180 days after surgery

All-cause mortality evaluated at 180 days after surgery.
From discharge to 180 days after surgery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

ASST Sette Laghi

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

29 juli 2026

Primärt slutförande (Beräknad)

31 juli 2028

Avslutad studie (Beräknad)

30 november 2028

Studieregistreringsdatum

Först inskickad

18 februari 2026

Först inskickad som uppfyllde QC-kriterierna

25 september 2026

Första postat (Faktisk)

1 oktober 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 september 2026

Senast verifierad

1 september 2025

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 25/2025

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • ANALYTIC_CODE
  • CSR

Läkemedels- och apparatinformation, studiedokument

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Nej

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Nej

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