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Use of wearables for pre- and postoperative monitoring of patients after radical robot-assisted or open cystectomy

Use of wearables for pre- and postoperative monitoring of patients after radical robot-assisted or open cystectomy - WARP-UP

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00036434
Enrollment
60
Registered
2025-05-02
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C67

Interventions

Group 1: Adult patients with planned radical robotic-assisted or open cystectomy receive a wearable for continuous recording of physiological parameters (heart rate, activity, sleep, temperature) for

Sponsors

Klinik für Urologie, UKSH Campus Kiel
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime 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

MeasureTime 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

Public ContactLeonhard Buck

Klinik für Urologie, UKSH Campus Kiel

leonhard.buck@uksh.de043150024801

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026