Clinical trial NCT03669419: QoR-9 AS predicTor of postopErative Complications
Official title: QoR-9 AS predicTor of postopErative Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Keywords: Outcome
Postoperative Complications
Failure to rescue
QoR-9
patient-centred questionnaire
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 3854
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Postoperative Complications evaluated by Clavien- Dindo Score
timeFrame: Date of Surgery till Discharge from Hospital (approximately 30 days)
Secondary outcomes:
measure: hospital mortality
timeFrame: Date of Surgery till Discharge from Hospital (approximately 30 days)
measure: 6-month mortality
timeFrame: 6 month after date of surgery
measure: Superiority of QoR-9 questionnaire against common Outcome Score
timeFrame: Date of surgery until 6 month follow-up
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinikum Rechts der Isar, Technische Universität München
state: Bavaria
Study officials:
affiliation: Department of Anesthesia, Klinikum rechts der Isar, TU Munich
name: Bettina Jungwirth, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.