Diabetes MellitusDIAPRO-BRESTNCT06553170
Anesthetic Management of Diabetes in Perioperative Urology and Visceral Surgery
An observational study of Diabetes Mellitus, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 196 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2017to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: all patients diabetics in Brest CHU
Who may be able to join
- patients diabetics
- urology or visceral surgery
Who cannot join
- ambulatory surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anesthetic Management of Diabetes in Perioperative Urology and Visceral Surgery: Adherence to a New Protocol at Brest CHU
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.
Read the detailed description
Half of the recommandations are implemented for each recommendation evaluated applicable in 29% of patients(n=25) in the before group versus 66.23% (n=52) in the after group (p<0.05).
This corresponds to an improvement significant of 36.23% for our primary endpoint.
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes, glycemic balance, anesthesia, perioperative medecine
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after
Secondary outcomes (1)
complications and mortality
Secondary endpoints are hospital mortality, the occurrence of early postoperative complications related to diabetes, the occurrence of complications post-operative surgery, and finally the occurrence of medical complications not related to Diabetes.
Measured: 1 year after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Dec 2017
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- anna cadic, Principal investigator, chru brest, france
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553170
- Sponsor's protocol ID
- DIAPRO-BREST (29BRC18.0128)
- Acronym
- DIAPRO-BREST
- Status last verified
- Sep 2019
- First submitted
- 10 Jun 2021
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Management of Diabetes in Perioperative Urology and Visceral Surgery: Adherence to a New Protocol at Brest CHU
- ClinicalTrials.gov ID
- NCT06553170
- Acronym / sponsor ID
- DIAPRO-BREST / DIAPRO-BREST (29BRC18.0128)
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes, glycemic balance, anesthesia, perioperative medecine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Half of the recommandations are implemented for each recommendation evaluated applicable in 29% of patients(n=25) in the before group versus 66.23% (n=52) in the after group (p<0.05).
This corresponds to an improvement significant of 36.23% for our primary endpoint.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- all patients diabetics in Brest CHU
Key inclusion criteria (2 listed)
- patients diabetics
- urology or visceral surgery
Key exclusion criteria (1 listed)
- ambulatory surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
follow the recommendations
Time frame: 1 year after
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 secondary outcome
complications and mortality
Time frame: 1 year after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
anna cadic principal investigator
chru brest, france
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
follow the recommendations (time frame: 1 year after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.