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

NCT07851350 | Recruiting

• 1 other identifier: 25/2025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prehabilitation; Major Abdominal Surgeries; Cardiac Surgery; Multimodal and Integrated Program; Major Surgery in Adult Patients

Keywords

Prehabilitation; Multimodal and Integrated program; Cardiac surgery; Abdominal Oncology Surgery; Major surgery

Outcome Measures

Primary Outcomes (1)

• 10% improvement from baseline at 6-minutes-walking-test-distance

  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

Secondary Outcomes (12)

• Increased thickness of the quadriceps femoris muscle

  From enrollment to the date of surgery

• Increased cross-sectional area of the quadriceps femoris muscle

  From enrollment to the date of surgery

• Increased pennation angle of the quadriceps femoris muscle

  From enrollment to the date of surgery

• Change in Pulmonary Function Parameters

  From enrollment to the date of surgery

• Improvement in Functional Performance Tests

  From enrollment to the date of surgery

Study Arms (1)

Eligible patients for major surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Elective major abdominal surgery or elective cardio surgery
• American Society of Anaesthesiologists Physical Status Classification ≤ 3
• Performance Status according to ECOG Scale ≤ 2

You may not qualify if:

• Emergency surgery
• Unstable angina
• Malignant arrythmias
• Severe/ very severe COPD
• Dementia
• Pregnancy
• Inability to provide informed consent

Sponsors & Collaborators

• ASST Sette Laghi: lead

Study Sites (2)

Ospedale di Circolo

Varese, VA, 21052, Italy

RECRUITING

ASST Sette Laghi

Varese, 21100, Italy

ACTIVE NOT RECRUITING

Central Study Contacts

Massimo Stella, MD

CONTACT

0039 0332393447; maxstella95@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: October 1, 2026
• Study Start: July 29, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: October 1, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

IT (2)