Postbariatric EArly Discharge Controlled by Healthdot (PEACH)

Philips

Status

Completed

Conditions

Bariatric Surgery Candidate

Treatments

Device: Healthdot application

Study type

Interventional

Funder types

Industry

Identifiers

NCT04754893

ICBE-2-36455

Details and patient eligibility

About

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.

Enrollment

208 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult (equal or above 18)
Approval for primary bariatric surgery (gastric sleeve or bypass) by a multidisciplinary bariatric team
Willing and able to sign informed consent form
Able to understand instructions
In possession of a telephone on which patient can be reached for the duration of participation (day 1-8)
An adult person must be present at the same location as the patient during the first night following surgery who is able to mobilize help or seek medical care if necessary.

Exclusion criteria

Patients of psychiatric wards, inmates of prisons, or other state institutions
Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
Any skin condition, for example prior rash, discoloration, scars or open wounds at the area (Left lower rib) where the Healthdot needs to be placed
Known allergy for the tissue adhesive used in the Healthdot (white band-aid)
Use of topical that is known to influence the skin at the test area (such as medical and non-medical creams or lotions)
Patient with active implantables such as Implantable Cardioverter Defibrilator (ICD) and pacemaker
Expected participation less than 8 days
Left lower rib (place where Healthdot will be applied) is involved in the area of surgery, area of disinfection or area where bandages are needed.
Patients with antibiotic resitant infections (e.g. MRSA)