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Completed

NCT Number: NCT03669419

QoR-9 AS predicTor of postopErative Complications

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.

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Key information

Conditions

Postoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Rechts der Isar, Technische Universität München

München, Bavaria, 81675, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QoR 9 Questionnaire

Diagnostic Test

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Sep 13, 2018
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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