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Risk Evaluation and Surveillance of Complications in UppEr GI and HPB Surgery

Risk Evaluation and Surveillance of Complications in UppEr GI and HPB Surgery - RESCUE

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00037909
Enrollment
376
Registered
2025-12-02
Start date
2026-03-23
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

postoperative complications

Interventions

Group 1: In the intervention group, patients are admitted to special monitor beds in the normal ward. Vital parameters (RR, HR, AF, SpO2) are continuously recorded via inpatient monitoring (MX450 incl

Sponsors

Klinik für Anästhesiologie und Intensivmedizin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Consent to participate in the study - Legal capacity of the patient - Elective surgery on the pancreas, liver, or esophagus - Transfer from an anesthesiological monitoring unit (PACU/IMC/IOI) to a normal ward if normal ward criteria are met

Exclusion criteria

Exclusion criteria: - Withdrawal of consent - Desire to terminate the study - Refusal by patient - Language barrier - Intensive inpatient therapy due to organ failure prior to randomization - Injury to both ear canals, hearing aids on both sides - Presence of a palliative treatment situation

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the recording of the postoperative course using the Comprehensive Complication Index up to the 30th postoperative day. It is calculated based on the grading of postoperative complications using the Clavien-Dindo classification.

Secondary

MeasureTime frame
• Exploratory presentation of complications according to CDC in the nine domains of the Postoperative Morbidity Survey (POMS) • Necessity of readmission to an anesthesiological monitoring ward (IMC, intensive care) (yes/no) and duration (in days) • Earlier detection of critical conditions through monitor surveillance • Duration of intervention (continuous monitoring in normal ward) • Frequency of MET deployment • Reduction in the severity of complications during the continuous monitoring interval • Quality of continuous monitoring (artifact rates, monitor-free time) • Length of hospital stay (in days) • Rehospitalization rate • Quality of life after 6 months (WHODAS 2.0, EQ-5D-5L) • 6-month mortality • Quality of recovery early postoperatively (QoR-15 (26)) • Cumulative activity and mobility in the postoperative phase • Complication recording according to classifications • Recording of postoperative delirium incidence

Countries

Germany

Contacts

Public ContactCatherina Bubb

Klinik für Anästhesiologie und Intensivmedizin

catherina.bubb@uniklinik-ulm.de+49 731 500 55421

Outcome results

None listed

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