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Perioperative dysglycemia-hyperglycemia, hypoglycemia, and glycemic variability-is associated with an increased risk for adverse outcomes. Several studies have reported the association between elevated preoperative HbA1c and postoperative complications.
There are no studies that confirm that postponing elective surgery improves patient outcomes. Likewise, no prospective trials have studied whether short-term glycemic control reduces postoperative complications and unnecessary patient delays in elective surgeries.
Consequently, this randomized controlled trial aimed to investigate the effects of short-term glycemic control before major abdominal surgery on postoperative morbidity and mortality.
Despite the limitations of measurements of HbA1c, guidelines for perioperative glycemic management suggest delaying elective surgery if HbA1c exceeds certain levels (7-8.5%) (Joshi et al., 2010; CPOC, 2022). However, no studies confirm that postponing elective surgery improves patient outcomes. Likewise, no prospective trials have studied whether short-term glycemic control reduces postoperative complications and unnecessary patient delays in elective surgeries (Duggan et al., 2017).
Consequently, this randomized controlled trial aimed to investigate the effects of short-term glycemic control before major abdominal surgery on postoperative morbidity and mortality. The study hypothesis is that in diabetic patients who are presenting for non-cardiac non-elective surgery and whose HbA1c is ≥7.5% (≥58 mmol/mol), short-term glycemic control would improve outcome compared to standard-of-care, as measured with days-at-home at 30 postoperative days (DAH-30).
The current study aims to detect the value of short-term glycemic control in uncontrolled diabetic patients (preoperative HbA1c ≥7.5% [≥58 mmol/mol]) for reducing postoperative morbidity and mortality.
The patients in the preoperative anesthesia clinic will be randomized into one of the upcoming groups:
Short-term glycemic control group:
Patients will be admitted to the hospital for 2-3 days before surgery. During this pilot study, patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose. We aim to maintain moderate glucose control (140 - 180 mg/dl) using basal-bolus insulin protocol plus correctional doses as needed.
Standard-of-care group: Patients will be admitted the day before surgery with the usual patient treatment.
In both groups, diabetic drugs will be managed per local protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short-term glycemic control group | Experimental | Patients will be admitted to the hospital for 2-3 days before surgery. During this pilot study, patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose. We aim to maintain moderate glucose control (140-180 mg/dl) using the basal-bolus insulin protocol, plus correctional doses as needed. |
|
| Standard-of-care group | Active Comparator | Patients will be admitted the day before surgery with the usual patient treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short-term glycemic control group | Other | Patients will be admitted to the hospital for 2-3 days before surgery. During this pilot study, patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose. We aim to maintain moderate glucose control (140-180 mg/dl) using the basal-bolus insulin protocol, plus correctional doses as needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days at home after surgery (DAH-30). | Continuous outcome as the number of days over the 30 days after surgery. | 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Loss of follow-up after surgery | Incidence (yes/no) outcome | 30 days after Surgery |
| Loss of follow up after the clinic preoperative assessment | incidence (yes/no) outcome |
| Measure | Description | Time Frame |
|---|---|---|
| Time to resumption of normal diabetes therapy | number in days | 60 days after surgery |
| Incidence of diabetic ketoacidosis or hypoglycemia | incidence (yes/no) outcome |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moataz M Emara, MD, EDAIC | Mansoura University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moataz Maher Emara | Al Mansurah | Aldakahlia | 35516 | Egypt |
The anonymized individual data will be available with the principal investigator on reasonable request after IRB approval within two years of publication.
Will be reported as soon as possible.
Will be reported as soon as possible.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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The patients in the preoperative anesthesia clinic are divided into one of the following groups:
Short-term glycemic control group:
Patients will be admitted to the hospital for 2-3 days before surgery. During this pilot study, patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose. We aim to maintain moderate glucose control (140 - 180 mg/dl) using basal-bolus insulin protocol plus correctional doses as needed.
Standard-of-care group: Patients will be admitted the day before surgery with the usual patient treatment.
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The outcome assessors, who will call patients or relatives 30 days after surgery, will be masked for the allocated group.
|
|
| Standard-of-care group | Other | Patients will be admitted the day before surgery with the usual patient treatment. |
|
|
| 30 days after initial assessment |
| 30-day mortality | incidence (yes/no) outcome | 30 days after surgery |
| Length of hospital stay | continuous outcome: number of days untill discharge from hospital after surgery | 30 days after surgery |
| incidence of postoperative complications | according to the comprehensive complications index (Kalt et al., 2023) | 30 days after surgery |
| Quality of Recovery15 (QoR-15) | a score of 15 items | after 24 hours of surgery |
| clinic-to-admission and clinic-to-surgery intervals | The time interval between the preoperative anesthesia clinic and admission or surgery in days, respectively. | 30 days |
| during the hospitalization period (within 30 days after surgery) |
| Incidence of use of intravenous insulin infusion therapy | incidence (yes/no) outcome | during the hospitalization period (within 30 days after surgery) |
| Duration of use of intravenous insulin infusion therapy | duration in days and hours | during the hospitalization period (within 30 days after surgery) |
| Change in diabetic management at 30 days | incidence (yes/no) outcome | during the hospitalization period (after 30 days after surgery) |
| D008722 | Methods |