QoR-9 AS predicTor of postopErative Complications

August 24, 2021 updated by: Technical University of Munich
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

3854

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • München, Bavaria, Germany, 81675
        • Klinikum rechts der Isar, Technische Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

3854 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Date of Surgery till Discharge from Hospital (approximately 30 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospital mortality
Time Frame: Date of Surgery till Discharge from Hospital (approximately 30 days)
Rate of Mortality among study patients
Date of Surgery till Discharge from Hospital (approximately 30 days)
6-month mortality
Time Frame: 6 month after date of surgery
Mortality among patients 6 months after surgery
6 month after date of surgery
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
Date of surgery until 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2017

Primary Completion (Actual)

December 6, 2019

Study Completion (Actual)

July 12, 2020

Study Registration Dates

First Submitted

August 6, 2018

First Submitted That Met QC Criteria

September 11, 2018

First Posted (Actual)

September 13, 2018

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QoR- ASPECT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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