Clinical trial NCT06269198: Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System
Official title: Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System Versus Standard of Care - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Complications
Cancer, Treatment-Related
Keywords: vital signs
continuous monitoring
wireless monitoring
postoperative physiology
postoperative complications
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
name: Hvidovre University Hospital
First posted: 2024-02-21
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomisation stratified by study site
Primary purpose: PREVENTION

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.

Detailed description: The primary objective of this study is to determine the effect on complication severity of using the WARD-CSS with automatic alerts in addition to routine monitoring versus routine monitoring alone in high-risk postoperative cancer patients within 30 days after surgery.

This study is a multicenter randomized controlled trial (RCT). Patients are randomly assigned to one of two parallel monitoring groups: (1)Intervention group - Monitoring by the WARD-CSS including vital signs and active alerts relayed to the nurses' smartphones during hospitalization. (2)Control group - Blinded data collection by the WARD-CSS without vital signs and active alerts displayed to the ward staff.

Both groups will receive routine vital signs monitoring (i.e. manual spot-checks) using the regional EWS/TOKS system according to current standards of care at the participating hospitals in the Capital Region or the Central Denmark Region.

The study is a collaboration between Rigshospitalet, Bispebjerg and Frederiksberg Hospital, and Hvidovre Hospital.

Patients will be recruited from abdominal (gastrointestinal, gynecological, or urological) surgery wards at the study sites.

Patients will be randomized post-surgery at the postoperative units/ post-anesthesia-care unit or after arrival at the ward. Continuous wireless monitoring (i.e., unblinded with alerts or blinded) will commence immediately after randomization in the study.

Only randomized patients will be included in the study population. Drop-outs prior to randomization will not be part of the study population.

The first 14 days of active enrollment at each new study site that has not previously used WARD-CSS will be used to align study procedures, verify system connectivity, etc. During this period, up to ten patients at each study site will be enrolled to be monitored similar to the intervention group. These run-in patients will not be randomized and will not be considered part of the study population.

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.)

Primary outcomes:
measure: Overall complication severity - 30 days
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Overall complication severity - 7 days
timeFrame: 7 days after surgery
measure: Frequency of Serious adverse events
timeFrame: 30 days after surgery
measure: Days alive and out of hospital
timeFrame: 30 days after surgery
measure: Days alive and out of hospital
timeFrame: 6 months after surgery
measure: Time to initiation of post-operative adjuvant chemotherapy
timeFrame: Outcomes will be collected up to 2 year after surgery
measure: Completion of post-operative adjuvant chemotherapy
timeFrame: Outcomes will be collected up to 2 year after surgery
Other outcomes:
measure: Frequency of severe clinical complications
timeFrame: 30 days after surgery
measure: ICU admission
timeFrame: 30 days after surgery.
measure: Surgical reintervention of any kind
timeFrame: 30 days after primary-surgery
measure: Post-discharge readmission
timeFrame: 6 months after surgery.
measure: Health-economic cost-effectiveness.
timeFrame: 2 years after surgery.
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University hospital - Rigshospitalet
state: Other (Non US)
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Other (Non US)
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
state: Other (Non US)
Study officials:
affiliation: Rigshospitalet, Denmark
name: Jesper Mølgaard, PhD
role: PRINCIPAL_INVESTIGATOR
References: