NCT06553170

Brief Summary

It is recognized that a poor glycemic, pre- and intraoperative balance is the source of increase in morbimortality. There was no local protocol at the CHRU Brest regarding the perioperative management of the diabetic patient. This retrospective observational work aims to assess the application of the French recommendations for the perioperative management of diabetes, and compare management before and after the introduction of a protocol based on its recommendations published in 2017 by the SFAR. The main endpoint is the percentage of patients for whom half of the patients recommendations from the local protocol were implemented for each of the recommendations evaluated and applicable to each patient, before and after protocol and staff training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

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, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2021

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

August 14, 2024

Completed
Last Updated

August 14, 2024

Status Verified

September 1, 2019

Enrollment Period

1.8 years

First QC Date

June 10, 2021

Last Update Submit

August 12, 2024

Conditions

Keywords

diabetesglycemic balanceanesthesiaperioperative medecine

Outcome Measures

Primary Outcomes (1)

  • follow the recommendations

    The main endpoint is the percentage of patients for whom half of patients recommendations of the local protocol were implemented for each of the recommendations evaluated and applicable to each patient, before and after the application of the protocol and training staff.

    1 year after

Secondary Outcomes (1)

  • complications and mortality

    1 year after

Study Arms (2)

before

all patients before the presentation of new protocol about management of diabètes in perioperative urology et visceral surgery

after

all patients after the presentation of new protocol about management of diabètes in perioperative urology et visceral surgery

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients diabetics in Brest CHU

You may qualify if:

  • patients diabetics
  • urology or visceral surgery

You may not qualify if:

  • ambulatory surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cadic

Brest, Brittany Region, 29200, France

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • anna cadic

    chru brest, france

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2021

First Posted

August 14, 2024

Study Start

December 1, 2017

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

August 14, 2024

Record last verified: 2019-09

Locations