QoR-9 AS predicTor of postopErative Complications

Technical University of Munich3,854 enrolled

Overview

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.

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

3,854

Conditions

Postoperative Complications

Interventions

QoR 9 QuestionnaireDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Klinikum Rechts der Isar, Technische Universität München

München, Bavaria, Germany

Outcomes

Primary Outcomes

Postoperative Complications evaluated by Clavien- Dindo Score

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).

Time frame: Date of Surgery till Discharge from Hospital (approximately 30 days)

Secondary Outcomes

hospital mortality

Rate of Mortality among study patients

Time frame: Date of Surgery till Discharge from Hospital (approximately 30 days)

6-month mortality

Mortality among patients 6 months after surgery

Time frame: 6 month after date of surgery

Superiority of QoR-9 questionnaire against common Outcome Score

Comparison of different risk estimates and Outcome Scores

Time frame: Date of surgery until 6 month follow-up

Data from ClinicalTrials.gov

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