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QoR-9 AS predicTor of postopErative Complications

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ClinicalTrials.gov Identifier: NCT03669419
Recruitment Status : Active, not recruiting
First Posted : September 13, 2018
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

Brief Summary:
Aim of the study is to evaluate, whether the self administered quality of recovery (QoR-9) questionnaire can predict postoperative complications after non-cardiac surgery and whether preoperative risk estimates can be improved by implementation of the QoR-9 as postoperative screening tool.

Condition or disease Intervention/treatment
Postoperative Complications Diagnostic Test: QoR 9 Questionnaire

Detailed Description:
The QoR-9 as established patient-centred outcome measure, which is validated in German language, is surveyed preoperatively, as well as on postoperative day 1 and 3 after non-cardiac surgery. We showed in a pilot study that this score reveals a high sensitivity to detect patients with a disturbed health status through a detailed and time-consuming physical examination.We want to evaluate if short screening tools can be used to categorize patients with increased risk for developing postoperative complicationsTherefore, patients undergoing non-cardiac surgery are informed preoperatively about the study and written informed consent is obtained. Afterwards, the QoR-9, as well as validated preoperative risk scores are obtained. Relevant intra- and immediate postoperative factors are recorded. On postoperative day 1 and 3 patients perform the QoR-9. Postoperative complications during hospital stay are determined using the Clavien Dindo score by searching the patients 'record. After 6 months the patients are contacted via telephone and the QoR-9 is obtained. 6-months mortality is determined.

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Study Type : Observational
Actual Enrollment : 4048 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: QoR-9 AS predicTor of postopErative Complications
Actual Study Start Date : September 14, 2018
Actual Primary Completion Date : July 11, 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery


Intervention Details:
  • Diagnostic Test: QoR 9 Questionnaire
    The QoR-9 as established patient-centred outcome measure, which is validated in German language, is surveyed preoperatively, as well as on postoperative day 1 and 3 after non-cardiac surgery. Postoperative complications are evaluated using the Clavien-Dindo Score. A follow-up is intended after 6 months. Preoperative risk is estimated using the ASA (American Society of Anesthesiologists) and the POSPOM (Preoperative Score to predict postoperative mortality) score.


Primary Outcome Measures :
  1. Postoperative Complications evaluated by Clavien- Dindo Score [ Time Frame: Date of Surgery till Discharge from Hospital (approximately 30 days) ]
    Nine domains are evaluated: Pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, wound, haematological and pain. Each domain is graded between grade I and V (death of a patient).


Secondary Outcome Measures :
  1. hospital mortality [ Time Frame: Date of Surgery till Discharge from Hospital (approximately 30 days) ]
    Rate of Mortality among study patients

  2. 6-month mortality [ Time Frame: 6 month after date of surgery ]
    Mortality among patients 6 months after surgery

  3. Superiority of QoR-9 questionnaire against common Outcome Score [ Time Frame: Date of surgery until 6 month follow-up ]
    Comparison of different risk estimates and Outcome Scores



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

4048 patients undergoing surgery at Klinikum Rechts der Isar, Technical University who have good knowledge of German Language.

Surgical procedures include all departments except cardiac surgery.

Criteria

Inclusion Criteria:

  • written informed consent
  • undergoing non-cardiac surgery
  • good knowledge of German language

Exclusion Criteria:

  • blind
  • out-patient
  • pregnant
  • psychiatric disturbance that preclude cooperation
  • decline to participate

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): NCT03669419


Locations
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Germany
Klinikum Rechts der Isar, Technische Universität München
München, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
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Study Director: Bettina Jungwirth, Prof. Department of Anesthesia, Klinikum rechts der Isar, TU Munich
Publications of Results:

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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT03669419    
Other Study ID Numbers: QoR- ASPECT
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Technische Universität München:
Outcome
Postoperative Complications
Failure to rescue
QoR-9
patient-centred questionnaire
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes