We hypothesise that using a continuous subcutaneous glucose monitor during pancreatic surgery, will significantly improve percentage of time spent in glycaemic target range (i.e. glucose ≥ 4 mmol/l and < 10 mmol/l).
ID
Bron
Verkorte titel
Aandoening
Pancreatic disease, diabetes mellitus
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Percentage of time spent in glycaemic target range (i.e. glucose ≥ 4 mmol/l and < 10 mmol/l).
Achtergrond van het onderzoek
Pancreatic surgery often results in impaired glucose metabolism or diabetes mellitus, depending on the endocrine function of the residual pancreatic parenchyma. Poor perioperative glycaemic control has been associated with unfavourable outcome after surgery. Therefore, patients undergoing pancreatic surgery may substantially benefit from improved glucose monitoring. In this study we will assess the efficacy of continuous glucose monitoring for perioperative glucose control in patients undergoing pancreatic surgery.
Doel van het onderzoek
We hypothesise that using a continuous subcutaneous glucose monitor during pancreatic surgery, will significantly improve percentage of time spent in glycaemic target range (i.e. glucose ≥ 4 mmol/l and < 10 mmol/l).
Onderzoeksopzet
Glucose will be measured by both the sensor and according to standard of care (POCT analyser) during the intraoperative and early postoperative period (day +1). On day + 30, follow-up by telephone or email is scheduled, after which trial participation ends.
Onderzoeksproduct en/of interventie
Patients will receive a subcutaneous glucose sensor on the day before surgery. The glucose values measured will be used to guide treatment during the intraoperative and early postoperative period. Glucose measurements will be confirmed using a point-of-care analyser.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Adult patients, aged between 18 and 85, undergoing either pancreaticoduodenectomy or distal pancreatectomy, willing and able to provide written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Unable to communicate in Dutch or English, psychiatric disorder or any other condition the local investigator feels would interfere with trial participation or measurements
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8055 |
| CCMO | NL70513.018.19 |