Actively Recruiting
Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System
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
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.
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
AI-Screening
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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
CONTACT
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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