NCT06269198 Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System
| NCT ID | NCT06269198 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Postoperative Complications |
| Study Type | INTERVENTIONAL |
| Enrollment | 504 participants |
| Start Date | 2023-10-31 |
| Primary Completion | 2025-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 504 participants in total. It began in 2023-10-31 with a primary completion date of 2025-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.)
Contact & Investigator
Jesper Mølgaard, PhD
PRINCIPAL INVESTIGATOR
Rigshospitalet, Denmark
Frequently Asked Questions
Who can join the NCT06269198 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Postoperative Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06269198 currently recruiting?
Yes, NCT06269198 is actively recruiting participants. Contact the research team at moelgaard.jesper@gmail.com for enrollment information.
Where is the NCT06269198 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Copenhagen, Denmark, Hvidovre, Denmark.
Who is sponsoring the NCT06269198 clinical trial?
NCT06269198 is sponsored by Rigshospitalet, Denmark. The principal investigator is Jesper Mølgaard, PhD at Rigshospitalet, Denmark. The trial plans to enroll 504 participants.