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Clinical Trials in Denmark / NCT06269198
Recruiting Not applicable

Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System

NCT06269198 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Rigshospitalet
Phase
Not applicable
Started
2023-10-31
Last updated
2025-01-15

Condition(s) studied

Postoperative ComplicationsCancer, Treatment-Related

Investigational drug(s) / intervention(s)

WARD-CSS

WARD-CSS: Patients' continuously monitored vital signs will be recorded via a bedside tablet device (data not visible). The clinical staff will have access to the continuously monitored vital signs through a mobile device (smart phone) with a purpose-built app-based GUI displaying vital sign status and summaries, alarms, and device connectivity. The GUI will alert the clinical staff (acoustic and visual signals) when any of the predefined thresholds for deviating vital signs are exceeded.

Study summary

The primary objective of this study is to determine the effect on complication severity of using a clinical monitoring system with automatic vital sign alerts in addition to routine monitoring versus routine monitoring alone in high-risk postoperative cancer patients within 30 days after surgery.

Other objectives include documentation of the severity of complications within seven days of surgery, frequency of serious adverse events, mortality, length of stay and delay of planned chemotherapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Admission for elective major abdominal (gastrointestinal, gynecological, or urological) surgery with the primary aim of radical surgery/removing suspected cancer tissue. * At least two expected postoperative admission days * Laparotomy or laparoscopy procedure estimated to last more than 2 hours. * Co-enrolment of patients in other studies is acceptable but in studies involving interventions which potentially will affect the continuous monitoring of vital signs and/or the primary or secondary outcomes, an assessment of whether these patients can be co-enrolled in the WARD-RCT should be conferred with the WARD RCT steering committee. Exclusion Criteria: * Patient expected not to cooperate with study procedures * Allergy to study materials (silicone, plaster) * Impaired cognitive function (in uncertain cases assessed by a Mini Mental State Examination score \< 24). (Protocol Appendix E) * Patients with a pacemaker or Implantable Cardioverter Defibrillator (ICD) device * Inability to give informed consent * Patients with planned hyperthermic intraperitoneal chemotherapy (HIPEC) procedure or two-stage resections (two-stage hepatectomy, two-stage resection of malignant colorectal obstructions, etc.)

Primary outcome measure(s)

  • Overall complication severity - 30 days — 30 days after surgery
    Severity of complications assessed by the Comprehensive Complication Index (CCI) score. Complications are defined according to internationally agreed definitions of complications. CCI can take on numerical values in the scale from 0 (no complications) to 100 (patient deceased).

Trial sites (3)

FacilityCityRegionStatus
Copenhagen University hospital - Rigshospitalet Copenhagen Other (Non US) Recruiting
Bispebjerg Hospital Copenhagen Other (Non US) Recruiting
Hvidovre Hospital Hvidovre Other (Non US) Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06269198 on ClinicalTrials.gov ↗ ← All trials in Denmark