- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06589466
Preoperative Optimization of Diabetic Patients
Retrospective Review of Preoperative Optimization of Diabetic Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Purpose: The purpose of this study to retrospectively determine the incidence of diabetes in the surgical population and what proportion of diabetic patients have a valid HbA1C. Hypothesis: A valid (measured within 3 months of surgery) HbA1C measurement is frequently missing prior to surgery and when present has a high chance of being higher than normal.
Objectives:
Perform a retrospective analysis of all surgeries in Alberta from November 2019 to the present time looking for the following:
Primary outcomes:
- Determine the incidence of diabetes in the surgical population and describe the demographics and clinical charcteristics of patients
- Determine the incidence of valid HbA1C in diabetic patients presenting for surgery
- Determine long-term diabetes control through assessment of HbA1C values in diabetic patients presenting for surgery
Secondary outcomes:
- Determine association between HbA1C and post-operative length of stay
- Determine association between HbA1C and in hospital mortality Design: This study will be a population-based, retrospective observational cohort study. Setting: Alberta Hospitals Participants: Adults with diabetes having surgery in Alberta since November 2019 Descriptive statistics will be tabulated according to HbA1C status and Univariate comparisons of means, medians and proportions will be performed to evaluate the association of independent variables with primary and secondary outcomes. Normally distributed continuous data will be reported as means with standard deviations (SD). Non-normally distributed continuous data will be reported as medians with interquartile ranges (IQR). Categorical variables will be compared using Chi-square test for independence
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G2R3
- University of Alberta
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 or greater
- Having any surgical procedure at any hospital in Alberta
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adults with diabetes having surgery in Alberta since November 2019
|
this study in observational study, no intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevelance of diabetes among surgical population
Time Frame: 11/2019-12/2023
|
Determine the incidence of diabetes in the surgical population
|
11/2019-12/2023
|
|
HB1AC measuerment in diabetic patients
Time Frame: 11/2019-12/2023
|
Determine the incidence of valid HbA1C in diabetic patients presenting for surgery
|
11/2019-12/2023
|
|
Long term diabetes control among surgical patients
Time Frame: 11/2019-12/2023
|
Determine long-term diabetes control through assessment of HbA1C values in diabetic patients presenting for surgery
|
11/2019-12/2023
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
In hospital mortality
Time Frame: 11/2019-12/2023
|
Determine association between HbA1C and in hospital mortality
|
11/2019-12/2023
|
|
Post-operative length of stay
Time Frame: 11/2019-12/2023
|
Determine association between HbA1C and post-operative length of stay
|
11/2019-12/2023
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- van den Boom W, Schroeder RA, Manning MW, Setji TL, Fiestan GO, Dunson DB. Effect of A1C and Glucose on Postoperative Mortality in Noncardiac and Cardiac Surgeries. Diabetes Care. 2018 Apr;41(4):782-788. doi: 10.2337/dc17-2232. Epub 2018 Feb 13.
- Dronge AS, Perkal MF, Kancir S, Concato J, Aslan M, Rosenthal RA. Long-term glycemic control and postoperative infectious complications. Arch Surg. 2006 Apr;141(4):375-80; discussion 380. doi: 10.1001/archsurg.141.4.375.
- Stryker LS, Abdel MP, Morrey ME, Morrow MM, Kor DJ, Morrey BF. Elevated postoperative blood glucose and preoperative hemoglobin A1C are associated with increased wound complications following total joint arthroplasty. J Bone Joint Surg Am. 2013 May 1;95(9):808-14, S1-2. doi: 10.2106/JBJS.L.00494.
- Jones CE, Graham LA, Morris MS, Richman JS, Hollis RH, Wahl TS, Copeland LA, Burns EA, Itani KMF, Hawn MT. Association Between Preoperative Hemoglobin A1c Levels, Postoperative Hyperglycemia, and Readmissions Following Gastrointestinal Surgery. JAMA Surg. 2017 Nov 1;152(11):1031-1038. doi: 10.1001/jamasurg.2017.2350.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00139994
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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