Postoperative Complications Clinical Trial
— WARD-SX-RCT-IIOfficial title:
Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System Versus Standard of Care - a Randomized Clinical Trial
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.
Status | Recruiting |
Enrollment | 504 |
Est. completion date | April 1, 2027 |
Est. primary completion date | April 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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.) |
Country | Name | City | State |
---|---|---|---|
Denmark | Bispebjerg Hospital | Copenhagen | Other (Non US) |
Denmark | Copenhagen University hospital - Rigshospitalet | Copenhagen | Other (Non US) |
Denmark | Hvidovre Hospital | Hvidovre | Other (Non US) |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Bispebjerg Hospital, Hvidovre University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Frequency of severe clinical complications | Frequency of severe clinical complications Defined as any complication fulfilling the Clavien-Dindo classification =2 | 30 days after surgery | |
Other | ICU admission | Number of patients with unplanned admission to the intensive care unit after surgery | 30 days after surgery. | |
Other | Surgical reintervention of any kind | Any unplanned surgical reintervention of any kind. | 30 days after primary-surgery | |
Other | Post-discharge readmission | Re-admission for any reason related to the operation or their respective cancer | 6 months after surgery. | |
Other | Health-economic cost-effectiveness. | Health-economic cost-effectiveness. Data will be collected from all available health care databases in the danish public health care system (ie. use of general practitioners, hospital admissions, hospital registered costs and services, work-leave periods) for a maximum follow up period of 2 years after primary surgery and analyzed when full datasets are available | 2 years after surgery. | |
Primary | Overall complication severity - 30 days | Severity of complications assessed by the Comprehensive Complication Index (CCI) score. Complications are defined according to internationally agreed definitions of complications.
CCI can take on numerical values in the scale from 0 (no complications) to 100 (patient deceased). |
30 days after surgery | |
Secondary | Overall complication severity - 7 days | Severity of complications assessed by the Comprehensive Complication Index (CCI) score. Complications are defined according to internationally agreed definitions of complications.
CCI can take on numerical values in the scale from 0 (no complications) to 100 (patient deceased). |
7 days after surgery | |
Secondary | Frequency of Serious adverse events | Frequency of Serious adverse events (SAE) SAE is defined by ICH-GCP criteria as: Any unfavourable medical occurrence that
results in death is life-threatening requires inpatient hospitalisation or prolongation of existing hospitalisation results in persistent or significant disability/incapacity is a congenital anomaly/birth defect |
30 days after surgery | |
Secondary | Days alive and out of hospital | Number of days alive and out of hospital | 30 days after surgery | |
Secondary | Days alive and out of hospital | Number of days alive and out of hospital | 6 months after surgery | |
Secondary | Time to initiation of post-operative adjuvant chemotherapy | For patients scheduled to recieve postoperative chemotherapy, this is the time from surgery to initiation of post-operative adjuvant chemotherapy | Outcomes will be collected up to 2 year after surgery | |
Secondary | Completion of post-operative adjuvant chemotherapy | For patients scheduled to recieve postoperative chemotherapy, this is the number of patients that complete their post-operative adjuvant chemotherapy. | Outcomes will be collected up to 2 year after surgery |
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