Noncardiac SurgeryPACORUS-DNCT04675905
Patient-Centred Outcomes and Resource Utilisation After Noncardiac Surgery-D(Eutschland) (PACORUS-D)
An observational study of Noncardiac Surgery, run by PD Dr. med. MSc Giovanna Lurati Buse.
Trial summary
The PACORUS-D project aims at 1) quantifying the 30-days and 1-year disability burden (assessed using the 12-item WHODAS 2 [WHO Disability Assessment Schedule] questionnaire) after inhospital noncardiac nonneurosurgical procedures ; 2) quantifying the resource utilization up the 1 year after inhospital noncardiac… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Noncardiac Surgery
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients fulfilling the eligibility criteria
Who may be able to join
- 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
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- 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.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
The PACORUS-D project aims at 1) quantifying the 30-days and 1-year disability burden (assessed using the 12-item WHODAS 2 [WHO Disability Assessment Schedule] questionnaire) after inhospital noncardiac nonneurosurgical procedures ; 2) quantifying the resource utilization up the 1 year after inhospital noncardiac nonneurosurgical procedures; 3) validating days alive and out of hospital (construct and criterion validity) in Germany. PACORUS-D consists of 2 independent cohort: a clinical multicentre cohort to assess "disability" and "days alive and out of hospital" and an administrative cohort to assess "days alive and out of hospital" and "resource utilization" from statutory health insurance data. PACORUS-D is intended as preparatory project in Germany before international expansion. THIS REGISTRATION REFERS TO THE CLINICAL COHORT ONLY.
Read the detailed description
Objectives:
1a) to quantify patient-reported disability measured using the 12-item WHO Disability Assessment Schedule (WHODAS) after noncardiac surgery
- 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;
- 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
- Noncardiac Surgery
- Being tested
- no intervention (cohort study)
- Keywords
- Outcome Assessment, Health Care [Mesh];, Surgical Procedures, Operative, Economics, noncardiac surgery, disability, patient-centred outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention (cohort study)Other
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
| Study group | Role | What they receive |
|---|---|---|
| PACORUS-D Main cohort | Eligibility, Endpoints as described above Receives: Other: no intervention (cohort study) | |
| 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 Receives: Other: no intervention (cohort study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
New onset clinically significant disability
applies to objectives 1a-b and 3a-b; Definition:increase in 12-item WHO Disability Assessment Schedule (WHODAS 2) score of at least 5% from baseline to a final WHODAS score of at least 35% (Shulman Anesthesiology 2020); For calculation of the 12-item WHODAS score percentage, the ordinal categories of Linkert scale for each item will be assigned numerical values (none=0 to extreme=4) for a total maximal score of 48 and transformed into the percentage of maximal disability score (Ustun, Bull World Health Organ, 2010); higher percentage indicates higher disability.
Measured: 365 days
Days alive and out of hospital
applies to objective 2a-c
Measured: 30 days
Secondary outcomes (2)
New onset clinically significant disability at 30 days
applies to objectives 1a-b and 3a-b; Definition see Outcome 1
Measured: 30 days
Days alive and out of hospital
applies to objective 2a-c
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start1 Feb 2021 (estimated)
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noncardiac SurgeryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PD Dr. med. MSc Giovanna Lurati Buse
- Sponsor type
- University, hospital or other
- Collaborators
- Heinrich-Heine University, Duesseldorf, University Hospital, Bonn, University Hospital, Aachen, University Hospital of Cologne, University Hospital, Essen, University Hospital Heidelberg, Ruhr University of Bochum, German Society of Anesthesiology and Intensive Care (DGAI)
- Responsible party
- Sponsor-investigator, PD Dr. med. MSc Giovanna Lurati Buse, Heinrich-Heine University, Duesseldorf
- Investigators
- Giovanna AL Lurati Buse, MD, MSc, Principal investigator, Anesthesiology Department, University Hospital Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675905
- Sponsor's protocol ID
- PACORUS-D
- Acronym
- PACORUS-D
- Status last verified
- Dec 2020
- First submitted
- 10 Dec 2020
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pseudonymized data can not be shared due to data protection regulation. Anonymized data might be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centred Outcomes and Resource Utilisation After Noncardiac Surgery-D(Eutschland) (PACORUS-D)
- ClinicalTrials.gov ID
- NCT04675905
- Acronym / sponsor ID
- PACORUS-D / PACORUS-D
- Conditions
- Noncardiac Surgery
- Keywords
- Outcome Assessment, Health Care [Mesh];, Surgical Procedures, Operative, Economics, noncardiac surgery, disability, patient-centred outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- PD Dr. med. MSc Giovanna Lurati BuseUniversity, hospital or other
- Collaborators
- Heinrich-Heine University, Duesseldorf, University Hospital, Bonn, University Hospital, Aachen, University Hospital of Cologne, University Hospital, Essen, University Hospital Heidelberg, Ruhr University of Bochum, German Society of Anesthesiology and Intensive Care (DGAI)
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 19 Dec 2020 (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 PACORUS-D project aims at 1) quantifying the 30-days and 1-year disability burden (assessed using the 12-item WHODAS 2 [WHO Disability Assessment Schedule] questionnaire) after inhospital noncardiac nonneurosurgical procedures ; 2) quantifying the resource utilization up the 1 year after inhospital noncardiac nonneurosurgical procedures; 3) validating days alive and out of hospital (construct and criterion validity) in Germany. PACORUS-D consists of 2 independent cohort: a clinical multicentre cohort to assess "disability" and "days alive and out of hospital" and an administrative cohort to assess "days alive and out of hospital" and "resource utilization" from statutory health insurance data. PACORUS-D is intended as preparatory project in Germany before international expansion. THIS REGISTRATION REFERS TO THE CLINICAL COHORT ONLY.
Detailed description
Objectives:
1a) to quantify patient-reported disability measured using the 12-item WHO Disability Assessment Schedule (WHODAS) after noncardiac surgery
- 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;
- 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%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PACORUS-D Main cohort | – | Other: no intervention (cohort study)Eligibility, Endpoints as described above |
| PACORUS-D Delirium-Subcohort | – | Other: no intervention (cohort study)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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients fulfilling the eligibility criteria
Key inclusion criteria (10 listed)
- aged ≥50 years
- non-cardiac, non-neurosurgical surgery (thoracic, vascular, abdominal, urinary tract, or orthopaedic/trauma)
- inhospital procedure
- they are unwilling or unable to provide informed consent,
- the procedure is cancelled
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| 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 | Other | PACORUS-D Delirium-Subcohort, PACORUS-D Main cohort |
Primary outcome
New onset clinically significant disability
Time frame: 365 days
applies to objectives 1a-b and 3a-b; Definition:increase in 12-item WHO Disability Assessment Schedule (WHODAS 2) score of at least 5% from baseline to a final WHODAS score of at least 35% (Shulman Anesthesiology 2020); For calculation of the 12-item WHODAS score percentage, the ordinal categories of Linkert scale for each item will be assigned numerical values (none=0 to extreme=4) for a total maximal score of 48 and transformed into the percentage of maximal disability score (Ustun, Bull World Health Organ, 2010); higher percentage indicates higher disability.
Days alive and out of hospital
Time frame: 30 days
applies to objective 2a-c
2 secondary outcomes
New onset clinically significant disability at 30 days
Time frame: 30 days
Days alive and out of hospital
Time frame: 365 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Individual participant dataSharing planned: No. Pseudonymized data can not be shared due to data protection regulation. Anonymized data might be shared upon reasonable request
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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. This study is not recruiting at the moment.
Giovanna AL Lurati Buse, MD, MSc principal investigator
Anesthesiology Department, University Hospital Düsseldorf
Questions about this trial
What is this clinical trial studying?
An observational study of Noncardiac Surgery, run by PD Dr. med. MSc Giovanna Lurati Buse.
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 10 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giovanna AL Lurati Buse, MD, MSc (+49-211-8117828, giovanna.luratibuse@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New onset clinically significant disability (time frame: 365 days). The study lists 2 primary outcomes in all. 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 19 Dec 2020.