Multimodal Prehabilitation for Major Surgery in Elderly Patients to Lower Complications and to Increase Cost Effectiveness: a Randomised, Prospective, Multicenter, Multidisciplinary Trial (PREHABIL Trial).
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Frail Elderly Syndrome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
- Enrollment
- 466
- Locations
- 1
- Primary Endpoint
- Comprehensive Complication Index (CCI)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This multicentric, randomised controlled trial is to the investigators knowledge the first implementation of a multimodal, multidisciplinary prehabilitation approach using knowledge from different specialties to lower complications and to increase cost effectiveness after major surgery in elderly, frail patients.
Detailed Description
Postoperative complications occur in up to 50% of patients and major surgery is associated with a 20 to 40% reduction in physiological and functional capacity. The elderly have surgery 4 times more often than the rest of the population, thus in the future a major proportion of patients presenting for surgery will be older than 65 years. Elderly patients have more postoperative complications, a longer convalescence and higher surgical morbidity and mortality. The number and severity of complications are closely related to preoperative functional capacity, nutritional state, psychological state, and smoking behavior. Another population most probably to benefit from such a program are cancer patients with decreased functional health after cancer treatment. Cancer prehabilitation affords an opportunity for the patient to improve functional status while waiting to begin treatment. This is a patient group expected to grow in the future. This is a multicenter, multidisciplinary, 2 arms (standard, n=233 vs intervention i.e. prehabilitation, n=233), randomised controlled trial (RCT). The prehabilitation program is composed of 4 elements: exercise training, nutritional intervention, correction of anaemia and smoking cessation. This multicentric, randomised controlled trial is to the investigators knowledge the first implementation of a multimodal, multidisciplinary prehabilitation approach using knowledge from different specialties to lower complications and to increase cost effectiveness after major surgery in elderly, morbid patients. The primary outcome is measured by the comprehensive complication index (CCI). Secondary outcomes are physical parameters measured by cardio-pulmonary exercise testing (CPET), grip strengh, Nutritional Risk Score (NRS). Further outcomes are amongst others smoking behavior, haemoglobin concentration, days at home at 30 days (DAH30) and quality of recovery 15 (QoR15).
Investigators
Dominique Engel
Dr.med.
Insel Gruppe AG, University Hospital Bern
Eligibility Criteria
Inclusion Criteria
- •Written informed consent
- •comorbid (≥ASA 3)
- •pre-existing fitness deficit: AT\<11ml/kg/min respectively VO2peak\<14ml/kg/min if AT unavailable or VE/VCO2 slope \> 33
- •scheduled for major urologic, thoracic, visceral, orthopaedic or cardiovascular surgery
- •screening at least 2 weeks prior to surgery
Exclusion Criteria
- •Paralysis or patients with mobility problems (who are unable to exercise),
- •Premorbid conditions or orthopaedic impairments that contraindicate exercise,
- •Cognitive disabilities,
- •Chronic renal failure (need for dialysis)
- •Emergency procedures.
Outcomes
Primary Outcomes
Comprehensive Complication Index (CCI)
Time Frame: 30 days after surgery
The comprehensive complication index (value from 0 = no complication to 100 = death) is a valuable, validated index for the assessment of multiple postoperative complications. It has been developed based on Swiss hospital data and has been validated internationally.
Secondary Outcomes
- Cardiovascular & Pulmonary(Before and after 2-4 weeks of prehabilitation, at 30 days)
- Nutrition & Bioimpendance(At the beginning of study, before and after surgery, at 30 days.)
- Anaemia(30 days after surgery)
- Smoking(At the beginning of study, before and after surgery, at 30 days.)
- Questionnaires for recovery, anxiety and cardiac risk(At the beginning of study, before and after surgery, at 30 days.)