Z51.4
Conditions
Interventions
Group 1: Control group: standard of care
Group 2: Intervention group: mutimodal prehabilitation supported by telemedicine from study inclusion until elective surgery:
Standard care + multimodal preope
Sponsors
Uniklinik RWTH Aachen, Klinik für Anästhesiologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Given informed consent 2. Adult patients (= 18 years) 3. Elective major abdominal surgery defined by expected ICU stay =24 hours 4. Surgery scheduled in = 10 days 5. Increased perioperative risk as defined by at least one of the following: a. Age =60 years b. Risk of or with established malnutrition (GLIM criteria stage 1 or 2) c. Risk of or with established sarcopenia (EWGSOP2 criteria = 2) d. Risk of or with established frailty (Clinical Frailty Scale =4)
Exclusion criteria
Exclusion criteria: • Patients < 18 years, pregnant or lactating patients • Patients unable to consent (cognitive, psychiatric, or severe language barriers) • < 10 days until elective surgery • Death expected within 3 months after screening due to severity of disease • Patients already receiving medical nutrition therapy at home (oral, enteral or parenteral nutrition) • Patients unable to follow orders from the study personnel • Technical barriers preventing tele-prehabilitation • Affected motor function or extremity impairments preventing the intervention or outcome assessment • Full enteral nutrition is contraindicated • Uncontrolled diabetes mellitus • Clinical fulminant hepatic failure or Cirrhosis Child’s Class C Liver Disease • Severely reduced kidney function • Known allergy/ intolerance to study nutrients • Enrolment in an industry sponsored randomized trial within the last 30 days (co-enrolment in academic randomized trials will be considered on a case-by-case basis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of the study protocol as determined by: •Technical feasibility: To determine if teleconsultation is feasible in this patient group oLow major technical difficulties: <10% (major difficulties are defined by disabling the teleconsultation, e.g. aborted/ disconnected videocall sessions, connection issues, problems with sound or video) oHigh patient acceptance: =80% (patient satisfaction questionnaire) •Safety: similar rates of serious adverse events (SAEs) during the intervention (target: <10 % differences between groups) •Compliance: high percentage of the prescribed nutrition and exercise interventions carried out (target =70%) •Recruitment: confirmation of recruitment rates: (target: = 3 patients/ month) | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical outcomes will be evaluated in an exploratory manner with the perspective to gain first insights and to find a suitable outcome parameter for the planned follow-up study. Clinical outcomes include: 1. Longitudinal analysis of nutritional status, muscle mass, frailty, sarcopenia, physical and respiratory function, and quality of life at inclusion, before surgery and at hospital discharge 2. Mortality (hospital, 30 days), hospital and ICU-length of stay 3. Duration of mechanical ventilation, vasopressor treatment and renal replacement therapy 4. Number of complications | — |
Countries
Germany
Contacts
Public ContactAileen Hill
Uniklinik RWTH Aachen, Klinik für Anästhesiologie
Outcome results
None listed