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Postbariatric EArly Discharge Controlled by Healthdot

NCT04754893 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2022-06-30

No results posted yet for this study

Summary

This clinical investigation is a single center patient preference trial in a tertiary hospital in the Netherlands, designed to compare the outcome of two different recovery paths after standard of care bariatric surgery. The difference between both recovery paths is that half of the patients will get the standard of care by staying one night in the hospital before returning home (group B), while the other half will receive a Healthdot directly after surgery and leave the hospital on the same day (evening) (group A). 200 patients will be recruited and can choose whether they want to be assigned to the the regular recovery path or receive a Healthdot and leave the hospital on the same day. If they have no preference they will be randomly assigned to one of the two groups. Patients in the outpatient recovery group will wear the Healthdot for 7 days at home and vital signs (heart rate and respiratory rate, together with context data on activity and posture) will be transmitted to the hospital to monitor recovery. The study is mainly designed to investigate if the clinical outcome in both groups is equal (non-inferiority) based on a combined outcome measures like 30 days readmission rate and patient satisfaction.

Conditions

  • Bariatric Surgery Candidate

Interventions

DEVICE

Healthdot application

Healthdot device is applied on subject's chest after surgery

Sponsors & Collaborators

  • Philips Electronics Nederland B.V. acting through Philips CTO organization

    lead INDUSTRY

Principal Investigators

  • Simon Nienhuijs · Catharina Hospital, Eindhoven, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-22
Primary Completion
2021-12-25
Completion
2021-12-25

Countries

  • Netherlands

Study Locations

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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 NCT04754893 on ClinicalTrials.gov