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Abdomen Disease clinical trials

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NCT ID: NCT04257344 Recruiting - Clinical trials for Surgery--Complications

Use of Wearables for Early Detection of Complications After Major Acute Abdominal Surgery

Start date: October 1, 2019
Phase:
Study type: Observational

The purpose of the study is to investigate whether glucose profile, sleep disturbances and heart rate variability measured with wearable devices is associated with postoperative recovery and complications within 30 days after major emergency abdominal surgery. The study is designed as an explorative, prospective cohort study. 40 patients undergoing major emergency abdominal surgery at Zealand's University Hospital Køge are included in the study, and inclusion occurs within 24 hours of end of surgery. Patients will be followed for 30 days, and three scheduled study visits are planned during follow up at postoperative day 10, 20 and 30. Glucose is measured continuously with a wearable subcutaneous sensor (Dexcom G6). Glucose readings are validated in the perioperative setting using blood glucose measurements obtained with standard finger-pricks 3-5 times a day during hospitalization. Actigraphy is used for assessing sleep- and activity patterns for the full study period. Heart rate variation is measured with a compact Holter monitor. Furthermore, the study assesses patient-reported quality of recovery, glucose metabolism, nutritional status and mobility. Various data on demographics, peri- and postoperative data will be extracted from the electronic patient chart.