NCT02995499

Brief Summary

The ASA-PS classification, a subjective classification system of the patients' preoperative health status, contains a certain problem concerning its interrater reliability. A comparison between anesthesiologic and surgical assessment of the preoperative patient condition has not yet been extensively investigated. The aim of this study is to examine the latter in a prospective, monocentric, observational study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
683

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 16, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

3 years

First QC Date

December 11, 2016

Last Update Submit

February 12, 2022

Conditions

ASA PS Klassifikation

Keywords

ASA-PS classificationinter-rater reliabilitygeneral surgery

Outcome Measures

Primary Outcomes (1)

  • Interrater reliability of the ASA classification

    Expressed as Krippendorff's alpha and as a Fleiss' kappa

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • Morbidity rate

    90 days postoperative

  • Mortality rate

    30 and 90 days postoperative

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing an operation under anesthesiologic treatment in the one-period-time from the study-beginning at the Department of General and Visceral Surgery of the University Clinic Frankfurt.

You may qualify if:

  • All patients undergoing an operation under anesthesiologic treatment in the one-period-time from the study-beginning at the Department of General and Visceral Surgery of the University Clinic Frankfurt.

You may not qualify if:

  • Patients with ASA-Class 6.
  • Patients undergoing surgery more than twice in the same hospital stay (only two evaluations per patient case admitted).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic Frankfurt

Frankfurt am Main, 60590, Germany

Location

Study Officials

  • Georgios Makridis, Dr. med.

    University Clinic Frankfurt

    PRINCIPAL INVESTIGATOR

  • Wolf Otto Bechstein, Prof. Dr.

    University Clinic Frankfurt

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist for Visceral Surgery, Department of General and Visceral Surgery

Study Record Dates

First Submitted

December 11, 2016

First Posted

December 16, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2019

Study Completion

August 1, 2022

Last Updated

February 15, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)