Patient-Centred Outcomes and Resource Utilisation After Noncardiac Surgery-D(Eutschland) (PACORUS-D)
NCT ID: NCT04675905
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
1200 participants
OBSERVATIONAL
2021-02-01
2022-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1a) to quantify patient-reported disability measured using the 12-item WHO Disability Assessment Schedule (WHODAS) after noncardiac surgery
1. b) to assess the impact of preoperative comorbidities (and frailty in patients aged ≥65 years) and procedural risk, and of postoperative complications on 365-day patient-reported disability after noncardiac surgery;
2. a) to quantify days alive and out of hospital (DAOH), a recently proposed, integrative, easily collected and statistically-efficient outcome after noncardiac surgery;
2b) to validate (construct \[convergent\] validity) DAOH at 30 and 365 days after noncardiac surgery, i.e. to assess impact of preoperative risk factors/procedural risk and postoperative complications on DAOH; 2c) to assess in a subcohort of patients ≥ 65 years, the construct (convergent) validity of DAOH in terms of frailty (Clinical Frailty Scale);
3a) to evaluate the criterion (concurrent) validity of DAOH for patient-reported disability at 30 days and 365 days; 3b) to evaluate the criterion (predictive) validity of DAOH at 30 days for patient-reported disability at 365 days.
In addition to the main study, patients≥ 65 years may opt to participate (separate consent) to a nested cohort study to assess the impact of delirium detected by Confusion Assessment Method (CAM) on 365-day patient-reported disability after noncardiac surgery and on DAOH.
Design:
prospective multicentre cohort with nested subcohort (Delirium)
Eligibility:
Inclusion criteria:
* aged ≥50 years
* non-cardiac, non-neurosurgical surgery (thoracic, vascular, abdominal, urinary tract, or orthopaedic/trauma)
* inhospital procedure
Patients will be excluded if:
* they are unwilling or unable to provide informed consent,
* the procedure is cancelled
* they are submitted to a procedure requiring only local anesthetics or analgosedation,
* they were submitted to ≥1 surgical procedure in the 7 days prior to enrollment
* they are unable to complete the WHODAS questionnaire (e.g. language or literacy barriers);
* they were previously enrolled in PACORUS.
Endpoints:
For objectives1a-b and 3a-b, the main endpoint will be "new onset clinically significant disability" at 365 days, defined as an increase in WHODAS score of at least 5% from baseline to a final WHODAS score of at least 35% (Shulman Anesthesiology 2020).
For objectives2a-c, the main endpoint will be days alive and out of hospital. The time horizon will be 30 days (primary) and 365 days.
Additional endpoints will include "new onset clinically significant disability" at 30 days and "clinical relevant disability" at 30 and at 365 days, defined as 12-item WHODAS exceeding 35% (Shulman Anesthesiology 2020); the continuous WHODAS score at 30 days and 365 days; disability defined at 25%.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PACORUS-D Main cohort
Eligibility, Endpoints as described above
no intervention (cohort study)
Explanatory variables include preoperative comorbidities, baseline disability, surgical risk, postoperative complications, sex, rural/urban area of residency, Oslo Social Support Scale; Clinical Frailty Scale in patients aged \>= 65 years
PACORUS-D Delirium-Subcohort
Eligibility: patients aged \>= 65 years undergoing noncardiac nonneurosurgical procedures (definition see above); Endpoints as described above; additional explanatory variable: postoperative Delirium detected by CAM on postoperative day 1 and 2
no intervention (cohort study)
Explanatory variables include preoperative comorbidities, baseline disability, surgical risk, postoperative complications, sex, rural/urban area of residency, Oslo Social Support Scale; Clinical Frailty Scale in patients aged \>= 65 years
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
no intervention (cohort study)
Explanatory variables include preoperative comorbidities, baseline disability, surgical risk, postoperative complications, sex, rural/urban area of residency, Oslo Social Support Scale; Clinical Frailty Scale in patients aged \>= 65 years
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* non-cardiac, non-neurosurgical surgery (thoracic, vascular, abdominal, urinary tract, or orthopaedic/trauma)
* inhospital procedure
Patients will be excluded if:
* they are unwilling or unable to provide informed consent,
* the procedure is cancelled
* they are submitted to a procedure requiring only local anesthetics or analgosedation,
* they were submitted to ≥1 surgical procedure in the 7 days prior to enrollment
* they are unable to complete the WHODAS questionnaire (e.g. language or literacy barriers);
* they were previously enrolled in PACORUS.
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Heinrich-Heine University, Duesseldorf
OTHER
University Hospital, Bonn
OTHER
University Hospital, Aachen
OTHER
University Hospital of Cologne
OTHER
University Hospital, Essen
OTHER
University Hospital Heidelberg
OTHER
Ruhr University of Bochum
OTHER
German Society of Anesthesiology and Intensive Care (DGAI)
UNKNOWN
PD Dr. med. MSc Giovanna Lurati Buse
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
PD Dr. med. MSc Giovanna Lurati Buse
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Giovanna AL Lurati Buse, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Anesthesiology Department, University Hospital Düsseldorf
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PACORUS-D
Identifier Type: -
Identifier Source: org_study_id