QoR-9 AS predicTor of postopErative Complications

NCT03669419 | Completed

• 1 other identifier: QoR- ASPECT
• Study Type: observational
• Target: 3,854
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications

Keywords

Outcome; Postoperative Complications; Failure to rescue; QoR-9; patient-centred questionnaire

Outcome Measures

Primary Outcomes (1)

• 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).

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

Secondary Outcomes (3)

• hospital mortality

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

• 6-month mortality

  6 month after date of surgery

• Superiority of QoR-9 questionnaire against common Outcome Score

  Date of surgery until 6 month follow-up

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• written informed consent
• undergoing non-cardiac surgery
• good knowledge of German language

You may not qualify if:

• blind
• out-patient
• pregnant
• psychiatric disturbance that preclude cooperation
• decline to participate

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinikum Rechts der Isar, Technische Universität München

München, Bavaria, 81675, Germany

Location

Related Publications (6)

• 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.

  PMID: 25058504 RESULT

• 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.

  PMID: 26207620 RESULT

• 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.

  PMID: 27106961 RESULT

• 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.

  PMID: 19797283 RESULT

• 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.

  PMID: 19153322 RESULT

• 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.

  PMID: 15273542 RESULT

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bettina Jungwirth, Prof.

  Department of Anesthesia, Klinikum rechts der Isar, TU Munich

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: September 13, 2018
• Study Start: June 20, 2017
• Primary Completion: December 6, 2019
• Study Completion: July 12, 2020
• Last Updated: August 25, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)