Actively Recruiting
Randomized Trial of WARD-CSS Continuous Monitoring Versus Standard Care for Postoperative Complications in High-Risk Cancer Patients
Led by Rigshospitalet, Denmark · Updated on 2025-01-15
504
Participants Needed
3
Research Sites
178 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
B
Bispebjerg Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether using the WARD-CSS, a clinical monitoring system with automatic vital sign alerts, reduces the severity of complications within 30 days after surgery in high-risk postoperative cancer patients. This multicenter randomized controlled trial compares WARD-CSS monitoring plus routine care to routine monitoring alone. The study also looks at complication severity within seven days, serious adverse events, mortality, length of hospital stay, and delays in planned chemotherapy. Participants are randomly assigned after surgery to either the intervention group, which receives continuous vital signs monitoring with alerts sent to nurses' smartphones, or the control group, which has blinded data collection without visible alerts. Both groups continue to receive routine manual vital signs checks as per hospital standards. The study includes patients from abdominal surgery wards at multiple hospitals, with continuous wireless monitoring starting immediately after randomization. During the study, participants will be monitored continuously while hospitalized, and their vital signs data will be recorded via bedside devices. Researchers will assess overall complication severity 30 days after surgery, along with other safety and outcome measures. The first 14 days at new sites include a run-in period to ensure system setup but do not involve randomization. The study monitors safety and treatment effects throughout the postoperative period.
CONDITIONS
Official Title
Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admission for elective major abdominal (gastrointestinal, gynecological, or urological) surgery aimed at removing suspected cancer tissue
- Expected postoperative hospital stay of at least two days
- Planned laparotomy or laparoscopy procedure estimated to last more than 2 hours
- Co-enrollment in other studies allowed if they do not affect monitoring or study outcomes
You will not qualify if you...
- Patients expected not to cooperate with study procedures
- Allergy to study materials such as silicone or plaster
- Impaired cognitive function, assessed by a Mini Mental State Examination score below 24
- Presence of pacemaker or implantable cardioverter defibrillator (ICD) devices
- Inability to provide informed consent
- Planned hyperthermic intraperitoneal chemotherapy (HIPEC) or two-stage resections
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Trial Site Locations
Total: 3 locations
1
Copenhagen University hospital - Rigshospitalet
Copenhagen, Other (Non US), Denmark, 1665
Actively Recruiting
2
Bispebjerg Hospital
Copenhagen, Other (Non US), Denmark, 2400
Actively Recruiting
3
Hvidovre Hospital
Hvidovre, Other (Non US), Denmark, 2650
Not Yet Recruiting
Research Team
J
Jesper Mølgaard, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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