SHOrt-term Glycemic Control for Reducing Post-SURGical Complications

NCT ID: NCT06334068

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-08
• Study Completion Date: 2025-04-23

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.

Conditions

Diabetes; Uncontrolled Diabtetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study 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 the basal-bolus insulin protocol, plus correctional doses as needed.

Group Type: EXPERIMENTAL

Short-term glycemic control group

Intervention Type: 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.

Standard-of-care group

Patients will be admitted the day before surgery with the usual patient treatment.

Group Type: ACTIVE_COMPARATOR

Standard-of-care group

Intervention Type: OTHER

Patients will be admitted the day before surgery with the usual patient treatment.

Interventions

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.

Intervention Type: OTHER

Standard-of-care group

Patients will be admitted the day before surgery with the usual patient treatment.

Intervention Type: OTHER

Other Intervention Names

Active Intervention; Control group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moataz M Emara, MD, EDAIC

Role: PRINCIPAL_INVESTIGATOR

Mansoura University Hospital

Locations

Moataz Maher Emara

Al Mansurah, Aldakahlia, Egypt

Countries

Egypt

Other Identifiers

MS.24.03.2725

Identifier Type: -

Identifier Source: org_study_id