Tele-Prehabilitation of out-patients before major abdominal surgery
- Conditions
- Z51.4Preparatory care for subsequent treatment, not elsewhere classified
- Registration Number
- DRKS00033409
- Lead Sponsor
- niklinik RWTH Aachen, Klinik für Anästhesiologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 70
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)
•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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility of the study protocol as determined by:<br>•Technical feasibility: To determine if teleconsultation is feasible in this patient group <br>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)<br>oHigh patient acceptance: =80% (patient satisfaction questionnaire)<br><br>•Safety: similar rates of serious adverse events (SAEs) during the intervention (target: <10 % differences between groups) <br><br>•Compliance: high percentage of the prescribed nutrition and exercise interventions carried out <br>(target =70%) <br><br>•Recruitment: confirmation of recruitment rates: (target: = 3 patients/ month)<br>
- Secondary Outcome Measures
Name Time Method 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. <br>Clinical outcomes include:<br>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<br>2.Mortality (hospital, 30 days), hospital and ICU-length of stay<br>3.Duration of mechanical ventilation, vasopressor treatment and renal replacement therapy<br>4.Number of complications <br>