Postbariatric EArly discharge Controlled by Healthdot
- Conditions
- Monitoring vital signs of patients after standard bariatric surgeryOutpatient surgeryvital sign measurement
- Registration Number
- NL-OMON49644
- Lead Sponsor
- Philips Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
- Adult (equal or greater than 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.
- 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 (lower left 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 implantable such as Implantable Cardioverter
Defibrillator (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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary objective:<br /><br>To evaluate whether performing bariatric surgery as outpatient surgery is not<br /><br>inferior to the current treatment based on a combined outcome measure.</p><br>
- Secondary Outcome Measures
Name Time Method