Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2023-08-27
2024-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Experimental
Study subjects submitted to the General Surgery Clinic for colorectal surgery. On admission day, patients will have a CGM sensor placed on the outer part of the upper arm. Patients will undergo standard surgical procedures and perioperative care. Glycemia will be continuously monitored for 10 days. The CGM sensor will be taken off during visit in Outpatient Clinic.
CGM (FreeStyle Libre 3)
FreeStyle Libre 3 system consists of a sensor that measures interstitial glycemia every minute and a dedicated application on mobile phone. Measurements are transmitted via Bluetooth to a mobile phone, that collects the data in the mobile application. Moreover, the study subject's application is connected to the doctor's application which allows remote real-time glycemia monitoring on another device.
Other Name: continuous glucose monitoring, CGM, FreeStyle Libre 3
Interventions
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CGM (FreeStyle Libre 3)
FreeStyle Libre 3 system consists of a sensor that measures interstitial glycemia every minute and a dedicated application on mobile phone. Measurements are transmitted via Bluetooth to a mobile phone, that collects the data in the mobile application. Moreover, the study subject's application is connected to the doctor's application which allows remote real-time glycemia monitoring on another device.
Other Name: continuous glucose monitoring, CGM, FreeStyle Libre 3
Eligibility Criteria
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Inclusion Criteria
* confirmed colorectal cancer qualified for surgery
Exclusion Criteria
* pregnant women
* people undergoing dialysis treatment
18 Years
ALL
No
Sponsors
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Medical University of Gdansk
OTHER
Responsible Party
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Principal Investigators
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Magdalena Antoszewska, MD
Role: PRINCIPAL_INVESTIGATOR
MUG Division of Dermatology, Venereology and Allergology
Piotr Spychalski, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
MUG Division of General Surgery
Jarosław Kobiela, Prof.
Role: PRINCIPAL_INVESTIGATOR
MUG Division of General Surgery
Locations
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UCC Division of Oncological, Transplant and General Surgery
Gdansk, Pomeranian, Poland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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NKBBN/780/2022
Identifier Type: -
Identifier Source: org_study_id
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