MedTrace Logo

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

NCT04257344 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2021-09-21

No results posted yet for this study

Summary

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.

Conditions

  • Surgery--Complications
  • Abdomen Disease

Sponsors & Collaborators

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Johan Johan, MD · Surgical department, Zealands University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2021-01-22
Completion
2021-02-20

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04257344 on ClinicalTrials.gov