Clinical trial NCT06011473: Continuous Glucose Monitoring for Colorectal Cancer
Official title: Continuous Glucose Monitoring for Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Continuous Glucose Monitoring
Colorectal Cancer
Keywords: cgm
Colorectal Cancer
continuous glucose monitoring
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hyperglycemia commonly occurs during surgery due to a reaction to metabolic stress and trauma. It has been shown that improper glycemia control leads to impaired wound healing and a higher risk of other postoperative complications.

The primary aim of our project is to assess the feasibility of the use of continuous glucose monitoring in measuring blood glucose levels in patients undergoing colorectal cancer surgery. The secondary aim is to analyze changes in perioperative blood glucose levels to understand the effects of stress and intraoperative interventions on the blood glucose level. The tertiary goal is to assess the predictive value of hyperglycemia for surgical site infection.

Detailed description: Hyperglycemia commonly occurs during surgery due to a reaction to metabolic stress and trauma. It has been shown that improper glycemia control leads to impaired wound healing and a higher risk of other postoperative complications. However, glucose levels measured in patients before surgery are taken infrequently, and there remains controversy regarding optimal management. Usually, a blood glucose meter is used to measure non-fasted blood glucose concentrations, and a single-point measurement can easily misrepresent the actual glycemic control. Continuous glucose monitoring allows for a minimally invasive real-time remote glycemia control and is providing insights into glucose regulation in patients, demonstrating significant periods of clinically silent hypoglycemia and hyperglycemia.

The primary aim of our project is to assess the feasibility of the use of CGM in measuring blood glucose levels in patients undergoing colorectal cancer surgery. The secondary aim is to analyze changes in perioperative blood glucose levels to understand the effects of stress and intraoperative interventions on the blood glucose level. The tertiary goal is to assess the predictive value of hyperglycemia for surgical site infection.

Eligibility criteria: Inclusion Criteria:

* written informed consent
* confirmed colorectal cancer qualified for surgery

Exclusion Criteria:

* patients who will be unable or will refuse to express informed concern
* pregnant women
* people undergoing dialysis treatment

Primary outcomes:
measure: feasibility of CGM system
timeFrame: 10 days
Secondary outcomes:
measure: perioperative glycemia
timeFrame: 10 days
measure: SSI rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: UCC Division of Oncological, Transplant and General Surgery
state: Pomeranian
Study officials:
affiliation: MUG Division of Dermatology, Venereology and Allergology
name: Magdalena Antoszewska, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MUG Division of General Surgery
name: Piotr Spychalski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MUG Division of General Surgery
name: Jarosław Kobiela, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: McConnell YJ, Johnson PM, Porter GA. Surgical site infections following colorectal surgery in patients with diabetes: association with postoperative hyperglycemia. J Gastrointest Surg. 2009 Mar;13(3):508-15. doi: 10.1007/s11605-008-0734-1. Epub 2008 Nov 11.