SHOrt-term Glycemic Control for Reducing Post-SURGical Complications (Surg-ShoGR)

Short-term Glycemic Control in Patients With Uncontrolled Diabetes Mellitus Before Major Abdominal Surgery for Reducing Morbidity and Mortality: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes; Uncontrolled Diabtetes
• Intervention / Treatment: Other: Short-term glycemic control group; Other: Standard-of-care group

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moataz M Emara, MD, EDAIC; Phone Number: 01064048848; Email: mm.emara@mans.edu.eg

Study Locations

• Egypt
  • Aldakahlia
    • Mansoura, Aldakahlia, Egypt, 35516
      • Moataz Maher Emara
      • Contact: Moataz M Emara, MD, EDAIC; Phone Number: 01064048848; Email: mm.emara@mans.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; Other Names: Active Intervention
Active Comparator: Standard-of-care group; Patients will be admitted the day before surgery with the usual patient treatment.	Other: Standard-of-care group; Patients will be admitted the day before surgery with the usual patient treatment.; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Moataz M Emara, MD, EDAIC, Mansoura University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MS.24.03.2725

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The anonymized individual data will be available with the principal investigator on reasonable request after IRB approval within two years of publication.
• IPD Sharing Time Frame: Will be reported as soon as possible.
• IPD Sharing Access Criteria: Will be reported as soon as possible.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No