Diabetes, Uncontrolled Diabtetes
Conditions
Brief summary
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.
Detailed description
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: 1. 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. 2. 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.
Interventions
OTHERShort-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 the basal-bolus insulin protocol, plus correctional doses as needed.
OTHERStandard-of-care group
Patients will be admitted the day before surgery with the usual patient treatment.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessors, who will call patients or relatives 30 days after surgery, will be masked for the allocated group.
Intervention model description
The patients in the preoperative anesthesia clinic are divided into one of the following groups: 1. 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. 2. Standard-of-care group: Patients will be admitted the day before surgery with the usual patient treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* all adult diabetic patients (≥18 years) of either sex scheduled for major abdominal surgery (estimated operative time is \> 2 hours) with Hb A1c ≥7.5% (58 mmol/mol).
Exclusion criteria
* Patients \< 18 years * Emergency Surgery * Elective surgery that can be postponed safely till glycemic control * Hb A1c \< 7.5% * Pregnant patients * Patient Refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days at home after surgery (DAH-30). | 30 days after surgery | Continuous outcome as the number of days over the 30 days after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery15 (QoR-15) | after 24 hours of surgery | a score of 15 items |
| Length of hospital stay | 30 days after surgery | continuous outcome: number of days untill discharge from hospital after surgery |
| Loss of follow-up after surgery | 30 days after Surgery | Incidence (yes/no) outcome |
| Loss of follow up after the clinic preoperative assessment | 30 days after initial assessment | incidence (yes/no) outcome |
| 30-day mortality | 30 days after surgery | incidence (yes/no) outcome |
| incidence of postoperative complications | 30 days after surgery | according to the comprehensive complications index (Kalt et al., 2023) |
| clinic-to-admission and clinic-to-surgery intervals | 30 days | The time interval between the preoperative anesthesia clinic and admission or surgery in days, respectively. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORMoataz M Emara, MD, EDAIC
Mansoura University Hospital
Outcome results
None listed