SHOrt-term Glycemic Control for Reducing Post-SURGical Complications
- Conditions
- Uncontrolled DiabtetesDiabetes
- Interventions
- Other: Standard-of-care groupOther: Short-term glycemic control group
- Registration Number
- NCT06334068
- Lead Sponsor
- Mansoura University
- 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, we designed a randomized controlled trial 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, we designed a randomized controlled trial to investigate the effects of short-term glycemic control before major abdominal surgery on postoperative morbidity and mortality. We hypothesize 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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).
- Patients < 18 years
- Emergency Surgery
- Elective surgery that can be postponed safely till glycemic control
- Hb A1c < 7.5%
- Pregnant patients
- Patient Refusal
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard-of-care group Standard-of-care group Patients will be admitted the day before surgery with the usual patient treatment. Short-term glycemic control group 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 the basal-bolus insulin protocol, plus correctional doses as needed.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Quality of Recovery15 (QoR-15) after 24 hours of surgery a score of 15 items
Loss of follow-up after surgery 30 days after Surgery Incidence (yes/no) outcome
Length of hospital stay 30 days after surgery continuous outcome: number of days untill discharge from hospital after surgery
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)
Trial Locations
- Locations (1)
Moataz Maher Emara
🇪🇬Mansoura, Aldakahlia, Egypt