Monitoring postoperative complications in cancer patients with a smart system
Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System Versus Standard of Care - a Randomized Clinical Trial
This study is testing a smart monitoring system that sends alerts about vital signs to see if it helps high-risk cancer patients recover better after surgery compared to regular monitoring.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 504 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Copenhagen, Other (Non US) and 2 other locations) |
| Trial ID | NCT06269198 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of an intelligent continuous monitoring system that provides automatic vital sign alerts compared to routine monitoring alone in high-risk postoperative cancer patients. It is a multicenter randomized controlled trial where patients will be assigned to either an intervention group receiving active alerts or a control group with blinded data collection. The study will assess the severity of complications, frequency of serious adverse events, mortality, length of hospital stay, and delays in planned chemotherapy within 30 days post-surgery.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing elective major abdominal surgery for cancer with an expected postoperative stay of at least two days.
Not a fit: Patients who are unable to cooperate with study procedures or have cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the severity of postoperative complications in cancer patients, leading to improved recovery outcomes.
How similar studies have performed: Other studies utilizing continuous monitoring systems have shown promising results, suggesting that this approach could be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
Copenhagen, Other (Non US) and 2 other locations
- Copenhagen University hospital - Rigshospitalet — Copenhagen, Other (Non US), Denmark (Recruiting)
- Bispebjerg Hospital — Copenhagen, Other (Non US), Denmark (Recruiting)
- Hvidovre Hospital — Hvidovre, Other (Non US), Denmark (Not_yet_recruiting)
Study contacts
- Principal investigator: Jesper Mølgaard, PhD — Rigshospitalet, Denmark
- Study coordinator: Jesper Mølgaard, PhD
- Email: moelgaard.jesper@gmail.com
- Phone: +4535453545
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.