Frail Elderly Syndrome, Major Surgery
Conditions
Keywords
Comprehensive Complication Index
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).
Interventions
PROCEDUREMultimodal Prehabilitation
A multimodal prehabilitation program (exercise, nutrition, anemia correction and smoking cessation).
Sponsors
University of Bern
Department of clinical research, Bern
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized, parallel group, multi-centre, multidisciplinary, active controlled trial
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comprehensive Complication Index (CCI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular & Pulmonary | Before and after 2-4 weeks of prehabilitation, at 30 days | Cardio-Pulmonary Exercise Test (CPET): Peak VO2, VO2 at VT1, peak VE, VE/VCO2 slope, O pulse, FEV1, FEV1/FVC, resting HR, HR reserve, resting systolic and diastolic BP, CPAx ICUD and CPAX HosD in case of ICU admission, Maximum inspiratory pressure , Grip strength, NTproBNP, serial hsTroponin in case of raised NTproBNP, change in preoperative P-POSSUM score |
| Nutrition & Bioimpendance | At the beginning of study, before and after surgery, at 30 days. | Nutritional Risk Score (NRS), Bio impedance: weight, muscle mass, fat mass, percent body fat, extracellular water/intracellular water, and phase angle, Fat Free Body Mass (FFM) and Lean body Mass (LBM), Days nil per mouth |
| Smoking | At the beginning of study, before and after surgery, at 30 days. | Successful smoking cessation rate, Exhaled CO measured. |
| Questionnaires for recovery, anxiety and cardiac risk | At the beginning of study, before and after surgery, at 30 days. | Quality of Recovery Score (QoR-15), State-Trait Anxiety Inventory Test (STAI-T), Duke Activity Status Index (DASI) |
| Anaemia | 30 days after surgery | Presence of anaemia, Transfusion rates in the first 30 days after surgery. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Other outcomes of interest | At 30/90 days | Length of hospital stay, Days at home at 30 days, Predicted costs for visceral interventions, CCI at 90 days |
Countries
Switzerland
Contacts
Primary ContactDominique A Engel, Dr
Backup ContactPatrick Wuethrich, Prof
Outcome results
None listed