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Completed

NCT Number: NCT06334068

SHOrt-term Glycemic Control for Reducing Post-SURGical Complications

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moataz Maher Emara

Al Mansurah, Aldakahlia, 35516, Egypt

About this study

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:

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Active Intervention

Standard-of-care group

Other

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

Other names: Control group

Primary outcomes

  1. Number of days at home after surgery (DAH-30).

    Time frame: 30 days after surgery

    Continuous outcome as the number of days over the 30 days after surgery.

Secondary outcomes

  1. Loss of follow-up after surgery

    Time frame: 30 days after Surgery

    Incidence (yes/no) outcome

  2. Loss of follow up after the clinic preoperative assessment

    Time frame: 30 days after initial assessment

    incidence (yes/no) outcome

  3. 30-day mortality

    Time frame: 30 days after surgery

    incidence (yes/no) outcome

  4. Length of hospital stay

    Time frame: 30 days after surgery

    continuous outcome: number of days untill discharge from hospital after surgery

  5. incidence of postoperative complications

    Time frame: 30 days after surgery

    according to the comprehensive complications index (Kalt et al., 2023)

  6. Quality of Recovery15 (QoR-15)

    Time frame: after 24 hours of surgery

    a score of 15 items

  7. clinic-to-admission and clinic-to-surgery intervals

    Time frame: 30 days

    The time interval between the preoperative anesthesia clinic and admission or surgery in days, respectively.

Other outcomes

  1. Time to resumption of normal diabetes therapy

    Time frame: 60 days after surgery

    number in days

  2. Incidence of diabetic ketoacidosis or hypoglycemia

    Time frame: during the hospitalization period (within 30 days after surgery)

    incidence (yes/no) outcome

  3. Incidence of use of intravenous insulin infusion therapy

    Time frame: during the hospitalization period (within 30 days after surgery)

    incidence (yes/no) outcome

  4. Duration of use of intravenous insulin infusion therapy

    Time frame: during the hospitalization period (within 30 days after surgery)

    duration in days and hours

  5. Change in diabetic management at 30 days

    Time frame: during the hospitalization period (after 30 days after surgery)

    incidence (yes/no) outcome

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2024
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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