QoR-9 AS predicTor of postopErative Complications

Postoperative Complications Clinical Trial

Official title:

QoR-9 AS predicTor of postopErative Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669419
• Other study ID #: QoR- ASPECT
• Status: Completed
• Start date: June 20, 2017
• Est. completion date: July 12, 2020

Study information

• Verified date: March 2021
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3854
• Est. completion date: July 12, 2020
• Est. primary completion date: December 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

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.

Locations

Country	Name	City	State
Germany	Klinikum Rechts der Isar, Technische Universität München	München	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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. — View 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. — View 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. — View 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 Anaesthesio — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	hospital mortality	Rate of Mortality among study patients	Date of Surgery till Discharge from Hospital (approximately 30 days)
Secondary	6-month mortality	Mortality among patients 6 months after surgery	6 month after date of surgery
Secondary	Superiority of QoR-9 questionnaire against common Outcome Score	Comparison of different risk estimates and Outcome Scores	Date of surgery until 6 month follow-up