QoR-9 AS predicTor of postopErative Complications

Sponsor
Technische Universität München (Other)
Overall Status
Completed
CT.gov ID
NCT03669419
Collaborator
(none)
3,854
1
36.7
104.9

Study Details

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 Phase
  • 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 :
Jun 20, 2017
Actual Primary Completion Date :
Dec 6, 2019
Actual Study Completion Date :
Jul 12, 2020

Outcome Measures

Primary Outcome Measures

  1. Postoperative Complications evaluated by Clavien- Dindo Score [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 [Date of Surgery till Discharge from Hospital (approximately 30 days)]

    Rate of Mortality among study patients

  2. 6-month mortality [6 month after date of surgery]

    Mortality among patients 6 months after surgery

  3. Superiority of QoR-9 questionnaire against common Outcome Score [Date of surgery until 6 month follow-up]

    Comparison of different risk estimates and Outcome Scores

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT03669419
Other Study ID Numbers:
  • QoR- ASPECT
First Posted:
Sep 13, 2018
Last Update Posted:
Aug 25, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2021