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Completed

NCT Number: NCT04754893

Postbariatric EArly Discharge Controlled by Healthdot

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.

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Key information

Conditions

Bariatric Surgery Candidate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Healthdot application

Device

Healthdot device is applied on subject's chest after surgery

Primary outcomes

  1. Mortality

    Time frame: Within 30 days after primary surgery

    Mortality will be determined from the patient medical record

  2. Severe postoperative complications (Clavien-Dindo IIIb or higher)

    Time frame: Within 30 days after primary surgery

    Severe postoperative complications will be determined from the patient medical record

  3. Readmission (at least one night in hospital)

    Time frame: Within 30 days after primary surgery

    Readmission will be determined from the patient medical record

  4. Mild complications (Clavien-Dindo II and IIIa)

    Time frame: Within 30 days after primary surgery

    Mild complications will be determined from the patient medical record

  5. Prolonged length of stay (3 days or more in hospital)

    Time frame: Within 30 days after primary surgery

    Prolonged length of stay will be determined from the patient medical record

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

Postbariatric EArly Discharge Controlled by Healthdot (PEACH)

Acronym: PEACH

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 15, 2021
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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