NCT03669419

QoR-9 AS predicTor of postopErative Complications

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,854 (actual)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Postoperative Complications

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-06-20
• Primary completion: 2019-12-06
• Completion: 2020-07-12
• First posted: 2018-09-13
• Last updated: 2021-08-25

Locations

1 site across 1 country: Germany