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Clinical Trials in Italy / NCT06404489
Active, not recruiting Not applicable

Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery (PROGRESS)

NCT06404489 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-05-16
Last updated
2026-05-11

Condition(s) studied

Oncological PatientsMajor Surgery

Investigational drug(s) / intervention(s)

Multimodal prehabilitation Program

Multimodal prehabilitation Program: A tailored intervention will be prescribed if specific physical, nutritional or psychological impairments will be identified during the assessment phase. Based on the data obtained during the multimodal assessment, different domains and levels of care will be prescribed, focusing on exercise training, and/or nutrition optimization, and/or distress-coping techniques. Different combinations of three domains will be utilized to maximize their synergistic anabolic effect. The duration of program will be set at 4 weeks. All activities will be performed in dedicated suites at each site, under supervision of qualified health professionals.

Study summary

The importance of postoperative rehabilitation on physical performance and recovery is well-recognized. However, the preoperative period constitutes a unique opportunity to address comorbidities and modifiable risk factors, improve functional capacity and address deficiencies in physiologic reserve, which might otherwise preclude surgery or significantly impede recovery.

Therefore, the aim of this study is to evaluate the efficacy of a multimodal program of prehabilitation in patients undergoing major oncological gastrointestinal surgery. The hypothesis is that severe post-operative complications within 30 days will be reduced in the treatment group compared to the control group.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * All adult patients (age \> 18 years) scheduled for elective gastrointestinal surgery for cancer. * Signed informed consent Exclusion Criteria: Co-morbid medical, physical, and mental conditions interfering with the ability to complete study procedures, such as: * acute or unstable cardio-respiratory conditions (e.g., unstable angina or symptomatic severe aortic stenosis) * severe/end-stage organ diseases (e.g., cardiac failure NYHA functional classes III-IV, COPD FEV1 \<50% pred, end-stage kidney or liver disease); * American Society of Anesthesiologists (ASA) physical status classes 4-5. * disabling orthopedic and neuromuscular disease. * psychosis, dementia; * symptomatic anemia. * Pregnancy

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Azienda Ospedaliera Universitaria Cagliari Sardinia
IRCCS San Raffaele Scientific Institute Milan Italy

More Università Vita-Salute San Raffaele trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06404489 on ClinicalTrials.gov ↗ ← All trials in Italy