Postoperative ComplicationsWARD-SX-RCT-IINCT06269198
Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System
A study testing WARD-CSS in people with Postoperative Complications and Cancer, Treatment-Related, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Cancer, Treatment-Related
- What is being tested?
- WARD-CSS
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 3 sitesDenmark
- Study dates
- 31 Oct 2023to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Copenhagen University hospital - Rigshospitalet
Copenhagen, Other (Non US), 1665
Jesper Mølgaard, PhD, +4535453545, jesper.moelgaard@regionh.dk
Eske K Aasvang, DMSc, +4535450802, eske.kvanner.aasvang.01@regionh.dk
- Recruiting
Bispebjerg Hospital
Copenhagen, Other (Non US), 2400
Christian S Meyhoff, PhD, +4524910542, christian.sylvest.meyhoff@regionh.dk
Christian S Meyhoff, PhD
- Not yet recruiting
Hvidovre Hospital
Hvidovre, Other (Non US), 2650
Katja B L Glud, RN, +4538625713, katja.balle.levring.glud@regionh.dk
Søren Kjær, MD
About this study
Official 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.
Read the 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.
- Being tested
- WARD-CSS
- Keywords
- vital signs, continuous monitoring, wireless monitoring, postoperative physiology, postoperative complications
- Medical subject headings
- Postoperative Complications, Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WARD-CSSDevice
Also called Continuous vital signs monitoring with real-time alerts
Patients' continuously monitored vital signs will be recorded via a bedside tablet device (data not visible).
The clinical staff will have access to the continuously monitored vital signs through a mobile device (smart phone) with a purpose-built app-based GUI displaying vital sign status and summaries, alarms, and device connectivity. The GUI will alert the clinical staff (acoustic and visual signals) when any of the predefined thresholds for deviating vital signs are exceeded.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Blinded data collection by the WARD-CSS without vital signs and active alerts displayed to the ward staff |
| Intervention arm | Experimental | Monitoring by the WARD-CSS including vital signs and active alerts relayed to the nurses' smartphones during hospitalization Receives: Device: WARD-CSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days after surgery
Secondary outcomes (6)
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).
Measured: 7 days after surgery
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
Measured: 30 days after surgery
Days alive and out of hospital
Number of days alive and out of hospital
Measured: 30 days after surgery
Days alive and out of hospital
Number of days alive and out of hospital
Measured: 6 months after surgery
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
Measured: Outcomes will be collected up to 2 year after surgery
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.
Measured: Outcomes will be collected up to 2 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start31 Oct 2023
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomisation stratified by study site
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital, Hvidovre University Hospital
- Responsible party
- Principal investigator, Jesper Mølgaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jesper Mølgaard, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269198
- Sponsor's protocol ID
- WARD - SX - RCT II
- Acronym
- WARD-SX-RCT-II
- Status last verified
- Jan 2025
- First submitted
- 6 Feb 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System Versus Standard of Care - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06269198
- Acronym / sponsor ID
- WARD-SX-RCT-II / WARD - SX - RCT II
- Keywords
- vital signs, continuous monitoring, wireless monitoring, postoperative physiology, postoperative complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 504 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital, Hvidovre University Hospital
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomisation stratified by study site
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Blinded data collection by the WARD-CSS without vital signs and active alerts displayed to the ward staff |
| Intervention arm | Experimental | Device: WARD-CSSMonitoring by the WARD-CSS including vital signs and active alerts relayed to the nurses' smartphones during hospitalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WARD-CSSAlso: Continuous vital signs monitoring with real-time alertsPatients' continuously monitored vital signs will be recorded via a bedside tablet device (data not visible). The clinical staff will have access to the continuously monitored vital signs through a mobile device (smart phone) with a purpose-built app-based GUI displaying vital sign status and summaries, alarms, and device connectivity. The GUI will alert the clinical staff (acoustic and visual signals) when any of the predefined thresholds for deviating vital signs are exceeded. | Device | Intervention arm |
Primary outcome
Overall complication severity - 30 days
Time frame: 30 days after surgery
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).
6 secondary outcomes
Overall complication severity - 7 days
Time frame: 7 days after surgery
Frequency of Serious adverse events
Time frame: 30 days after surgery
Days alive and out of hospital
Time frame: 30 days after surgery
Days alive and out of hospital
Time frame: 6 months after surgery
Time to initiation of post-operative adjuvant chemotherapy
Time frame: Outcomes will be collected up to 2 year after surgery
Completion of post-operative adjuvant chemotherapy
Time frame: Outcomes will be collected up to 2 year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No. No plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jesper Mølgaard, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WARD-CSS in people with Postoperative Complications and Cancer, Treatment-Related, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jesper Mølgaard, PhD (+4535453545, moelgaard.jesper@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall complication severity - 30 days (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.