Continuous blood glucose monitoring for early detection of complications after pancreatic surgeries

Résumé de l'étude

If you are undergoing surgery on the pancreas, esophagus, or colon/rectum, you will be informed about the study during the consultation. No further examinations or blood draws are required preoperatively if you choose to participate in the study. Should you consent, you will be instructed in detail and 5 days before the surgery, a Dexcom G6® sensor will be attached to the back of your upper arm (left arm for right-handed individuals and vice versa). This will remain in place for the next 10 days. This sensor measures your daily blood glucose levels before the surgery. Immediately after the surgery, a second sensor will also be placed on the back of the same upper arm. The second sensor is necessary because intraoperative electrocoagulation can disrupt the measurement accuracy of the first sensor. The second sensor will also remain in place for a total of 10 days. Therefore, in the first 5 days after the surgery, data from 2 sensors will be measured. The blood glucose trend during this entire period will be forwarded to the conducting study physician (PD Dr.med. Patryk Kambakamba). Your blood glucose values are accessible to you and the study physician at any time and will be stored on the secure server of the Cantonal Hospital of Winterthur. It will then be investigated whether blood glucose changes show a correlation with postoperative complications. No further examinations or blood draws are required.

(BASEC)

Intervention étudiée

In this study, we plan for the first time the continuous monitoring of blood glucose after pancreatic surgeries, using the above-mentioned Dexcom G6® sensor. We hope that the insights from this study will improve blood glucose management for this patient group (pancreas/liver) in the future and detect complications early.

Should you consent, you will be instructed in detail and 5 days before the surgery, a Dexcom G6® sensor will be attached to the back of your upper arm (left arm for right-handed individuals and vice versa). This will remain in place for the next 10 days. This sensor measures your daily blood glucose levels before the surgery. Immediately after the surgery, a second sensor will also be placed on the back of the same upper arm. The second sensor is necessary because intraoperative electrocoagulation can disrupt the measurement accuracy of the first sensor. The second sensor will also remain in place for a total of 10 days. Therefore, in the first 5 days after the surgery, data from 2 sensors will be measured.

The blood glucose trend during this entire period will be forwarded to the conducting study physician (PD Dr.med. Patryk Kambakamba). Your blood glucose values are accessible to you and the study physician at any time and will be stored on the secure server of the Cantonal Hospital of Winterthur.

It will then be investigated whether blood glucose changes show a correlation with postoperative complications. No further examinations or blood draws are required.

(BASEC)

Maladie en cours d'investigation

The pancreas (via insulin, glucagon) is essential for maintaining a normal blood glucose level. Therefore, changes in blood glucose after surgeries on the pancreas are to be expected. In this study, we plan for the first time the continuous monitoring of blood glucose after pancreatic surgeries, using the above-mentioned Dexcom G6® sensor. We hope that the insights from this study will improve blood glucose management for this patient group (pancreas) in the future and detect complications early. If you are undergoing surgery on the pancreas, you are generally eligible for the study. Participation in the study is only possible with your written consent. You can withdraw from the study at any time. To exclude that similar blood glucose changes are caused by other major abdominal surgeries, we also include patients undergoing esophageal or colon/rectal surgeries.

(BASEC)

Sponsor

non disponible

Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)

Commission cantonale de Zurich

(BASEC)

Date d'approbation du comité d'éthique

17.03.2023

(BASEC)

Résultats de l'essai