Postbariatric EArly Discharge Controlled by Healthdot

Bariatric Surgery Candidate Clinical Trial

— PEACH  

Official title:

Postbariatric EArly Discharge Controlled by Healthdot (PEACH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04754893
• Other study ID #: ICBE-2-36455
• Status: Completed
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: December 25, 2021

Study information

• Verified date: January 2022
• Source: Philips Electronics Nederland B.V. acting through Philips CTO organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: December 25, 2021
• Est. primary completion date: December 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Device:
• Healthdot application
Healthdot device is applied on subject's chest after surgery

Locations

Country	Name	City	State
Netherlands	Catharina Hospital	Eindhoven	Noord-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Philips Electronics Nederland B.V. acting through Philips CTO organization

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality will be determined from the patient medical record	Within 30 days after primary surgery
Primary	Severe postoperative complications (Clavien-Dindo IIIb or higher)	Severe postoperative complications will be determined from the patient medical record	Within 30 days after primary surgery
Primary	Readmission (at least one night in hospital)	Readmission will be determined from the patient medical record	Within 30 days after primary surgery
Primary	Mild complications (Clavien-Dindo II and IIIa)	Mild complications will be determined from the patient medical record	Within 30 days after primary surgery
Primary	Prolonged length of stay (3 days or more in hospital)	Prolonged length of stay will be determined from the patient medical record	Within 30 days after primary surgery