Moataz Maher Emara
Al Mansurah, Aldakahlia, 35516, Egypt
NCT Number: NCT06334068
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.
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All sexes
Interventional
Not applicable
Al Mansurah, Aldakahlia, 35516, Egypt
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:
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.
In both groups, diabetic drugs will be managed per local protocol.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Active Intervention
Patients will be admitted the day before surgery with the usual patient treatment.
Other names: Control group
Time frame: 30 days after surgery
Continuous outcome as the number of days over the 30 days after surgery.
Time frame: 30 days after Surgery
Incidence (yes/no) outcome
Time frame: 30 days after initial assessment
incidence (yes/no) outcome
Time frame: 30 days after surgery
incidence (yes/no) outcome
Time frame: 30 days after surgery
continuous outcome: number of days untill discharge from hospital after surgery
Time frame: 30 days after surgery
according to the comprehensive complications index (Kalt et al., 2023)
Time frame: after 24 hours of surgery
a score of 15 items
Time frame: 30 days
The time interval between the preoperative anesthesia clinic and admission or surgery in days, respectively.
Time frame: 60 days after surgery
number in days
Time frame: during the hospitalization period (within 30 days after surgery)
incidence (yes/no) outcome
Time frame: during the hospitalization period (within 30 days after surgery)
incidence (yes/no) outcome
Time frame: during the hospitalization period (within 30 days after surgery)
duration in days and hours
Time frame: during the hospitalization period (after 30 days after surgery)
incidence (yes/no) outcome
Mansoura University
Other
Short-term Glycemic Control in Patients With Uncontrolled Diabetes Mellitus Before Major Abdominal Surgery for Reducing Morbidity and Mortality: A Randomized Controlled Trial
Acronym: ShoGR-Surg
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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