Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery (PROGRESS)
Evaluation of a Multimodal Program of Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery Within an ERAS Pathway.
Università Vita-Salute San Raffaele
400 participants
May 16, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- All adult patients (age \> 18 years) scheduled for elective gastrointestinal surgery for cancer.
- Signed informed consent
Exclusion Criteria8
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06404489