SHOrt-term Glycemic Control for Reducing Post-SURGical Complications

NCT06334068 | Completed DMC

• 1 other identifier: MS.24.03.2725
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Uncontrolled Diabtetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Loss of follow-up after surgery

  30 days after Surgery

• Loss of follow up after the clinic preoperative assessment

  30 days after initial assessment

• 30-day mortality

  30 days after surgery

• Length of hospital stay

  30 days after surgery

• incidence of postoperative complications

  30 days after surgery

Other Outcomes (5)

• Time to resumption of normal diabetes therapy

  60 days after surgery

• Incidence of diabetic ketoacidosis or hypoglycemia

  during the hospitalization period (within 30 days after surgery)

• Incidence of use of intravenous insulin infusion therapy

  during the hospitalization period (within 30 days after surgery)

Study Arms (2)

Short-term glycemic control group

EXPERIMENTAL

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

Standard-of-care group

ACTIVE COMPARATOR

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

Other: Standard-of-care group

Interventions

Short-term glycemic control group 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.

Also known as: Active Intervention

Short-term glycemic control group

Standard-of-care group OTHER

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

Also known as: Control group

Standard-of-care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Patients \< 18 years
• Emergency Surgery
• Elective surgery that can be postponed safely till glycemic control
• Hb A1c \< 7.5%
• Pregnant patients
• Patient Refusal

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Moataz Maher Emara

Al Mansurah, Aldakahlia, 35516, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Moataz M Emara, MD, EDAIC

  Mansoura University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors, who will call patients or relatives 30 days after surgery, will be masked for the allocated group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 27, 2024
• Study Start: May 8, 2024
• Primary Completion: February 23, 2025
• Study Completion: April 23, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Will be reported as soon as possible.
• Access Criteria: Will be reported as soon as possible.

Locations

EG (1)