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Patient-Centred Outcomes and Resource Utilisation After Noncardiac Surgery-D(Eutschland) (PACORUS-D) (PACORUS-D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04675905
Recruitment Status : Unknown
Verified December 2020 by PD Dr. med. MSc Giovanna Lurati Buse, Heinrich-Heine University, Duesseldorf.
Recruitment status was:  Not yet recruiting
First Posted : December 19, 2020
Last Update Posted : December 19, 2020
Sponsor:
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)
Information provided by (Responsible Party):
PD Dr. med. MSc Giovanna Lurati Buse, Heinrich-Heine University, Duesseldorf

Brief 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 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.

Condition or disease Intervention/treatment
Noncardiac Surgery Other: no intervention (cohort study)

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient-Centred Outcomes and Resource Utilisation After Noncardiac Surgery-D(Eutschland) (PACORUS-D)
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Group/Cohort Intervention/treatment
PACORUS-D Main cohort
Eligibility, Endpoints as described above
Other: 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
Other: 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




Primary Outcome Measures :
  1. 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.

  2. Days alive and out of hospital [ Time Frame: 30 days ]
    applies to objective 2a-c


Secondary Outcome Measures :
  1. New onset clinically significant disability at 30 days [ Time Frame: 30 days ]
    applies to objectives 1a-b and 3a-b; Definition see Outcome 1

  2. Days alive and out of hospital [ Time Frame: 365 days ]
    applies to objective 2a-c


Other Outcome Measures:
  1. Clinical relevant disability [ Time Frame: 30 days and 365 days ]
    Definition:12-item WHODAS 2 exceeding 35% (Shulman Anesthesiology 2020); for calculation of WHODAS percentage please refer to outcome 1

  2. Continuous 12-item WHODAS 2 score [ Time Frame: 30 days and 365 days ]
  3. Disability [ Time Frame: 30 days anf 365 days ]
    Definition: 12-item WHODAS 2 exceeding 25% (Ustun, Bull World Health Organ, 2010); for calculation of WHODAS percentage please refer to outcome 1



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients fulfilling the eligibility criteria
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04675905


Contacts
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Contact: Giovanna AL Lurati Buse, MD, MSc +49-211-8117828 giovanna.luratibuse@med.uni-duesseldorf.de

Sponsors and Collaborators
PD Dr. med. MSc Giovanna Lurati Buse
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)
Investigators
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Principal Investigator: Giovanna AL Lurati Buse, MD, MSc Anesthesiology Department, University Hospital Düsseldorf
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Responsible Party: PD Dr. med. MSc Giovanna Lurati Buse, Principal Investigator, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT04675905    
Other Study ID Numbers: PACORUS-D
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pseudonymized data can not be shared due to data protection regulation. Anonymized data might be shared upon reasonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PD Dr. med. MSc Giovanna Lurati Buse, Heinrich-Heine University, Duesseldorf:
Outcome Assessment, Health Care [Mesh];
Surgical Procedures, Operative, Economics
noncardiac surgery
disability
patient-centred outcome