Do Anesthesiologists Follow Belgian KCE Guidelines for Pr... | NCT05805124

Studies
Do Anesthesiologists Follow Belgian KCE Guidelines for Preoperative Evaluation?

NCT05805124

Sponsor

Erasme University Hospital

Status

Completed

Last Update Posted

Aug 30, 2023Actual

Enrollment

2,521Actual

Phase

Not provided

Conditions

Surgery

Interventions

Preop evaluation

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2023Actual

Primary Completion Date

Aug 25, 2023Actual

Completion Date

Aug 29, 2023Actual

First Submitted Date

Mar 28, 2023

First Submission Date that Met QC Criteria

Mar 28, 2023

First Posted Date

Apr 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2023

Last Update Posted Date

Aug 30, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

For more than 50 years it has been shown that preoperative evaluations by anesthesiologists include too many unnecessary tests. Many of the tests ordered do not change the management of the patients. One example are preoperative coagulation tests which rarely give relevant information and can be omitted if the patients have a negative structured bleeding questionnaire. This situation has lead to the publication of many guidelines on preoperative evaluation, one of the most comprehensive being the 2022 guidelines by the European Society of Cardiology for the preoperative evaluation of cardiac patients undergoing non-cardiac surgery.

In Belgium, an independent center of experts, the Kenniscentrum - Centre d'Expertise (KCE) was created to give expert and independent opinions on healthcare related subjects. These recommendations are often used by Belgian authorities to guide public health law and determine which medical procedures or tests are covered by the social security.

The KCE has published an extensive guide on preoperative evaluation of patients undergoing non-cardiac surgery (KCE Reports 280Bs. D/2016/10.273/102.) These guidelines are freely available, either in print version, on the dedicated Website or as an App, and have been extensively spread in the anesthesiology community. Laboratory tests not recommended in these guidelines are not covered by the social security if no solid reason is given in the medical chart.

In this retrospective study, adherence to the KCE guidelines on preoperative evaluations will be evaluated in a tertiary University hospital. All patients, scheduled for elective surgery, will be included for a period of 3 month. For every patient the recommended tests will be determined and compared to the actual tests prescribed by the anesthesiologist during the preadmission visit.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,521Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Preop evaluation	Diagnostic Test	All preop evaluations prescribed in the preadmission clinic will be recorded, especially: renal function tests hematologic tests coagulation tests hepatic function tests ECG cardiac function tests pulmonary function tests endocrine function tests

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adherence to KCE recommendations in percentage	Every tests prescribed in the anesthesiology preadmission clinic will be compared to the KCE recommendations. Each test will be classified as "appropriate" or "not recommended". The percentage of adherence to the KCE guidelines will be reported for each test.	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients examined at the anesthesiology preadmission clinic during Oct 1st 2022 and december 31st 2022 and scheduled for elective surgery at Erasme University hospital under general or locoregional anesthesia

Exclusion Criteria:

Non elective surgery
Age < 18 years
surgery under local anesthesia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients scheduled for elective surgery under general or locoregional anesthesia at Erasme University hospital seen at the anesthesiology preadmission clinic during Oct 1st 2022 and Dec 31st 2022

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Universitaire de Bruxelles - Hôpital erasme		Brussels		1070	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided