Preoperative functional optimization for adults undergoing major cardiac or abdominal surgery
Official title: 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
Run by ASST Sette Laghi · NCT07851350 · Data updated 2026-11-12
This study tests a four‑week prehabilitation program to improve fitness before elective major cardiac or abdominal surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | ASST Sette Laghi Academic / other |
| Locations | 2 sites (Varese, VA and 1 other locations) |
| Status | Recruiting |
| Started | July 29, 2026 |
| Main results expected | July 31, 2028 |
| Study ends | November 30, 2028 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT07851350 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults scheduled for elective major abdominal or elective cardiac surgery with ASA ≤ 3 and ECOG ≤ 2.
✕Probably not a fit
Patients with emergency surgery, unstable angina, malignant arrhythmias, very severe COPD, dementia, pregnancy, or inability to consent may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational program evaluates a prehabilitation pathway designed to enhance patients' functional abilities before major surgery. It applies a multimodal approach aligned with enhanced recovery principles to improve respiratory strength, physical conditioning, and overall readiness for surgery. The focus is on the preoperative period, aiming to enable safer procedures and faster return to daily activities after surgery. Participants are adults undergoing elective major cardiac or abdominal procedures and are monitored based on standard eligibility criteria. No specific interventions are described beyond the prehabilitation pathway itself in this description.
Why it matters
Potential benefit: If successful, patients may experience better postoperative recovery and reduced complication risk due to improved functional status before surgery.
How similar studies have gone: Prehabilitation and ERAS‑aligned programs have shown promise in improving perioperative outcomes in prior studies, though this specific pathway in major cardiac and abdominal surgery is not widely established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Ospedale di Circolo
Varese, VA, Italy Recruiting -
ASST Sette Laghi
Varese, Italy Active not recruiting
Study contacts
- Study coordinator: Massimo Stella, MD
- Email: maxstella95@gmail.com
- Phone: 0039 0332393447
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.