C67
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. planned open or robot-assisted cystectomy 2. age of the patient =18 years and capacity to consent 3. mobile patient who is not dependent on a walking aid 4. patient gives consent by signing and dating the consent form before the surgical procedure.
Exclusion criteria
Exclusion criteria: 1. emergency cystectomy 2. skin diseases that prevent the wearing of wearables 3. lack of compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of continuous use of a wearable in the perioperative setting will be evaluated based on patient adherence, i.e. the actual wearing time of the wearable over the entire study period. The endpoint is quantified by the automatically recorded activity data of the wearable (e.g. number of steps, pulse, sleep data). The data is synchronised daily and stored pseudonymously. The target criterion is an average wearing time of at least 16 hours per day. The evaluation is carried out retrospectively using the fully transmitted wearable data. In addition, acceptance is assessed using a standardised patient questionnaire at the end of the observation period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Early detection of postoperative complications (e.g. infections, circulatory problems) by analysing physiological parameters that are continuously recorded using a wearable before and after a robot-assisted or open radical cystectomy. Heart rate, heart rate variability, resting heart rate, activity level, sleep patterns and temperature changes are recorded over a period of up to 8 weeks perioperatively. Measurements are taken automatically via the wearable and the data is synchronised daily. The retrospective evaluation is carried out with regard to the occurrence of clinically documented complications (e.g. fever, infection, tachycardia, circulatory instability) that were recorded during the clinical course or in the medical records. The aim is to identify patterns in the physiological data that precede the occurrence of these complications. | — |
Countries
Germany
Contacts
Klinik für Urologie, UKSH Campus Kiel