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QoR-9 AS predicTor of postopErative Complications

QoR-9 AS predicTor of postopErative Complications

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03669419
Enrollment
3854
Registered
2018-09-13
Start date
2017-06-20
Completion date
2020-07-12
Last updated
2021-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTQoR 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.

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Complications evaluated by Clavien- Dindo ScoreDate 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

MeasureTime frameDescription
hospital mortalityDate of Surgery till Discharge from Hospital (approximately 30 days)Rate of Mortality among study patients
6-month mortality6 month after date of surgeryMortality among patients 6 months after surgery
Superiority of QoR-9 questionnaire against common Outcome ScoreDate of surgery until 6 month follow-upComparison of different risk estimates and Outcome Scores

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026