protocolSection identificationModule nctId: NCT06269198, orgStudyIdInfo id: WARD - SX - RCT II, briefTitle: Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System, acronym: WARD-SX-RCT-II, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-31, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, collaborators name: Bispebjerg Hospital, collaborators name: Hvidovre University Hospital, descriptionModule briefSummary: 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., conditionsModule conditions: Postoperative Complications, conditions: Cancer, Treatment-Related, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomisation stratified by study site, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Participants will not be given information on group allocation. Care-providers will not be blinded, due to having to carry out the intervention.Investigator will not be blinded to carrie out roles such as safety surveillance, error-solving and quality assurance.Outcome assessor will be blinded to study allocation., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 504, type: ESTIMATED, armsInterventionsModule interventions name: WARD-CSS, outcomesModule primaryOutcomes measure: Overall complication severity - 30 days, secondaryOutcomes measure: Overall complication severity - 7 days, secondaryOutcomes measure: Frequency of Serious adverse events, secondaryOutcomes measure: Days alive and out of hospital, secondaryOutcomes measure: Days alive and out of hospital, secondaryOutcomes measure: Time to initiation of post-operative adjuvant chemotherapy, secondaryOutcomes measure: Completion of post-operative adjuvant chemotherapy, otherOutcomes measure: Frequency of severe clinical complications, otherOutcomes measure: ICU admission, otherOutcomes measure: Surgical reintervention of any kind, otherOutcomes measure: Post-discharge readmission, otherOutcomes measure: Health-economic cost-effectiveness., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Copenhagen University hospital - Rigshospitalet, status: RECRUITING, city: Copenhagen, state: Other (Non US), zip: 1665, country: Denmark, contacts name: Jesper Mølgaard, PhD, role: CONTACT, phone: +4535453545, email: jesper.moelgaard@regionh.dk, contacts name: Eske K Aasvang, DMSc, role: CONTACT, phone: +4535450802, email: eske.kvanner.aasvang.01@regionh.dk, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Bispebjerg Hospital, status: RECRUITING, city: Copenhagen, state: Other (Non US), zip: 2400, country: Denmark, contacts name: Christian S Meyhoff, PhD, role: CONTACT, phone: +4524910542, email: christian.sylvest.meyhoff@regionh.dk, contacts name: Christian S Meyhoff, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Hvidovre Hospital, status: NOT_YET_RECRUITING, city: Hvidovre, state: Other (Non US), zip: 2650, country: Denmark, contacts name: Katja B L Glud, RN, role: CONTACT, phone: +4538625713, email: katja.balle.levring.glud@regionh.dk, contacts name: Søren Kjær, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.65719, lon: 12.47364, hasResults: False