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NCT Number: NCT04167410

Effect of Perioperative Glycemia Protocol on Glycemic Outcomes in Diabetic Patients Undergoing Abdominal Surgery

This study evaluated to the effects of a glycaemic control protocol directed by nurses during the perioperative period on glycaemic outcomes in diabetic patients undergoing major abdominal surgery. The study was conducted at the department of general surgery of a research and training hospital.The study included 47 patients who underwent elective major abdominal surgery between September 2017 and December 2018. The number of patients in the intervention and the control groups was 22 and 25, respectively. The glycemia control protocol will be used in the glycemia management of intervention group,routine glycemia management will be used in the control group.

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Key information

Conditions

Hyperglycemia Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Perioperative Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gulhane Research and Training Hospital

Ankara, 06010, Turkey (Türkiye)

About this study

The prevalence of diabetes among the surgical patient population is 10-15%, and surgical operations are administered to diabetic patients more frequently compared to non-diabetic patients. Diabetes or hyperglycaemia in surgical patients increases mortality and morbidity rates during the perioperative period by 50% compared to non-diabetic patients. Maintaining patient blood glucose (BG) levels of within the target range during the surgical period is crucial to prevent postoperative complications. The target BG level has been modified in line with recent scientific findings; institutions (such as the American Diabetes Association), have prepared new guidelines for the management of glycaemia in critically ill and surgical patients. Insulin infusion is the most effective method to control glycaemia in patients with critical disease or in patients about to undergo major surgery. Therefore, current guidelines recommend the use of reliable and practical glycaemia control protocols during insulin infusion. These protocols should be learnt by all members of the team that provide healthcare. Existing studies suggest that glycaemic management protocols are effective methods to achieve the target BG range and decrease the prevalence of hyperglycaemia and hypoglycaemia in critically ill and major surgery patients in a reliable and effective way.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

;

  • Patients were diagnosed with type 2 diabetes
  • Patients planned to undergo elective major abdominal surgery

Exclusion criteria

;

  • Patients who had diabetes other than type 2 diabetes
  • Patient who had a preoperative glycated haemoglobin A1C (HbA1C) value of 8.5% or greater
  • Patient planned to undergo surgery related to the pancreas

Treatment and study plan

glycaemic management protocol implemented to clinic

Other

Following the introduction of the glycaemic management protocol to the clinic, data on the patients in the intervention group was collected prospectively between June 2018 and December 2018. Data of the patients in the intervention group was collected after the patient applied to the hospital for surgery or just after the decision on surgery was taken. Patients in the intervention group whose HbA1C values exceeded 7% were referred to endocrinology specialists prior to surgery. Glycaemic management of these patients was evaluated at the department of endocrinology and medications or doses of insulin and oral antidiabetics were changed when necessary. Glycaemic management was conducted by nurses in line with the protocolConsequently, the glycaemic management of patients during the perioperative period was conducted by general surgery nurses according to the protocol.

Primary outcomes

  1. Rates of hyperglycaemia development

    Time frame: Each participant was followed between 7-10 days postoperatively. Data of the control group was collected within 8 months prospectively. Data of the intervention group was collected within 7 months prospectively.

    Capillary BG > 180 mg/dl refers to hyperglycemia.

  2. Insulin consumption rate

    Time frame: Each participant was followed between 7-10 days postoperatively. Data of the control group was collected within 8 months prospectively. Data of the intervention group was collected within 7 months prospectively.

    Insulin consumption of each participant was calculatedIn in the postoperative period.

  3. Rates of hypoglycaemia development

    Time frame: Each participant was followed between 7-10 days postoperatively. Data of the control group was collected within 8 months prospectively. Data of the intervention group was collected within 7 months prospectively.

    Capillary blood glucose (BG) < 70 mg/dl refers to hypoglycemia.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Other

Registry information

Official study title

Effects of Perioperative Glycemic Management Protocol on Glycemic Outcomes of Type 2 Diabetic Patients Undergoing Major Abdominal Surgery: a Non-Randomized Controlled Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Nov 18, 2019
Registry last updated
Jan 23, 2020

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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