QoR-9 AS predicTor of postopErative Complications

• ClinicalTrials.gov Identifier: NCT03669419
• Recruitment Status: Completed
• First Posted: September 13, 2018
• Last Update Posted: August 25, 2021
• Sponsor: Technische Universität München
• Information provided by (Responsible Party): Technische Universität München

Study Description

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.

Condition or disease	Intervention/treatment
Postoperative Complications	Diagnostic Test: QoR 9 Questionnaire

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 3854 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: QoR-9 AS predicTor of postopErative Complications
• Actual Study Start Date: June 20, 2017
• Actual Primary Completion Date: December 6, 2019
• Actual Study Completion Date: July 12, 2020

Groups and Cohorts

Intervention Details:

• 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Locations

Germany

Klinikum Rechts der Isar, Technische Universität München

München, Bavaria, Germany, 81675

Sponsors and Collaborators

Technische Universität München

Investigators

• Study Director: Bettina Jungwirth, Prof.; Department of Anesthesia, Klinikum rechts der Isar, TU Munich

More Information

Publications of Results:

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.

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.

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.

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.

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.

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.

• Responsible Party: Technische Universität München
• ClinicalTrials.gov Identifier: NCT03669419
• Other Study ID Numbers: QoR- ASPECT
• First Posted: September 13, 2018
• Last Update Posted: August 25, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Technische Universität München:

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

Additional relevant MeSH terms:

Postoperative Complications; Pathologic Processes