Monitoring postoperative complications in cancer patients with a smart system

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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 — Copenhagen University Hospital, Rigshospitalet
• Study coordinator: Jesper Mølgaard, PhD
• Email: moelgaard.jesper@gmail.com
• Phone: +4535453545

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.