QoR-9 AS predicTor of postopErative Complications

NCT ID: NCT03669419

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3854 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-20
• Study Completion Date: 2020-07-12

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bettina Jungwirth, Prof.

Role: STUDY_DIRECTOR

Department of Anesthesia, Klinikum rechts der Isar, TU Munich

Locations

Klinikum Rechts der Isar, Technische Universität München

München, Bavaria, Germany

Countries

Germany

References

Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.

Reference Type: RESULT

PMID: 25058504 (View on PubMed)

Anetsberger A, Blobner M, Krautheim V, Umgelter K, Schmid S, Jungwirth B. Self-Reported, Structured Measures of Recovery to Detect Postoperative Morbidity. PLoS One. 2015 Jul 24;10(7):e0133871. doi: 10.1371/journal.pone.0133871. eCollection 2015.

Reference Type: RESULT

PMID: 26207620 (View on PubMed)

Myles PS, Grocott MP, Boney O, Moonesinghe SR; COMPAC-StEP Group. Standardizing end points in perioperative trials: towards a core and extended outcome set. Br J Anaesth. 2016 May;116(5):586-9. doi: 10.1093/bja/aew066. No abstract available.

Reference Type: RESULT

PMID: 27106961 (View on PubMed)

Ghaferi AA, Birkmeyer JD, Dimick JB. Variation in hospital mortality associated with inpatient surgery. N Engl J Med. 2009 Oct 1;361(14):1368-75. doi: 10.1056/NEJMsa0903048.

Reference Type: RESULT

PMID: 19797283 (View on PubMed)

Regenbogen SE, Ehrenfeld JM, Lipsitz SR, Greenberg CC, Hutter MM, Gawande AA. Utility of the surgical apgar score: validation in 4119 patients. Arch Surg. 2009 Jan;144(1):30-6; discussion 37. doi: 10.1001/archsurg.2008.504.

Reference Type: RESULT

PMID: 19153322 (View on PubMed)

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

Reference Type: RESULT

PMID: 15273542 (View on PubMed)

Other Identifiers

QoR- ASPECT

Identifier Type: -

Identifier Source: org_study_id