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Preoperative Optimization of Diabetic Patients

Retrospective Review of Preoperative Optimization of Diabetic Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06589466
Enrollment
46000
Registered
2024-09-19
Start date
2025-01-22
Completion date
2026-12-31
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Surgery Related Complications Rate

Brief summary

Diabetic patients, as part of preoperative evaluation, should have glycated hemoglobin (HbA1C) measured. HbA1C provides information on longterm glucose control. There is a suggestion in the literature that elevated A1C levels predict a higher rate of postoperative adverse events, including infections, myocardial infarction, and mortality. It is unclear whether chronic glycemia, as reflected in raised HbA1C level, is the risk factor for adverse perioperative events or whether it is a surrogate measure for poor perioperative glucose management. Conversely, in a retrospective analysis of 431,480 surgeries perioperative glucose was predictive of increased 30-day mortality, but that HbA1C was a less useful predictor of this measure. In our experience of at the University of Alberta Preadmission Clinic there is significant variability with respect to whether diabetic patients have a valid HbA1C measurement i.e. within 3 months of surgery. If a valid measurement is present, there is also considerable variability with respect to diabetes control.

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: 1. Determine the incidence of diabetes in the surgical population and describe the demographics and clinical charcteristics of patients 2. Determine the incidence of valid HbA1C in diabetic patients presenting for surgery 3. Determine long-term diabetes control through assessment of HbA1C values in diabetic patients presenting for surgery Secondary outcomes: 1. Determine association between HbA1C and post-operative length of stay 2. 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

Interventions

OTHERSurgery

this study in observational study, no intervention.

Sponsors

University of Alberta
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age 18 or greater * Having any surgical procedure at any hospital in Alberta

Design outcomes

Primary

MeasureTime frameDescription
Prevelance of diabetes among surgical population11/2019-12/2023Determine the incidence of diabetes in the surgical population
HB1AC measuerment in diabetic patients11/2019-12/2023Determine the incidence of valid HbA1C in diabetic patients presenting for surgery
Long term diabetes control among surgical patients11/2019-12/2023Determine long-term diabetes control through assessment of HbA1C values in diabetic patients presenting for surgery

Secondary

MeasureTime frameDescription
In hospital mortality11/2019-12/2023Determine association between HbA1C and in hospital mortality
Post-operative length of stay11/2019-12/2023Determine association between HbA1C and post-operative length of stay

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026