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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Healthdot directly after surgery and leave the hospital on the same day (evening) (group A) |
|
| Group b | No Intervention | Standard of care by staying one night in the hospital before returning home (group B) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthdot application | Device | Healthdot device is applied on subject's chest after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Mortality will be determined from the patient medical record | Within 30 days after primary surgery |
| 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 |
| Readmission (at least one night in hospital) | Readmission will be determined from the patient medical record | Within 30 days after primary surgery |
| Mild complications (Clavien-Dindo II and IIIa) | Mild complications will be determined from the patient medical record | Within 30 days after primary surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon Nienhuijs | Catharina Hospital, Eindhoven, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catharina Hospital | Eindhoven | North Brabant | 5623 EJ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37415024 | Derived | van Ede ES, Scheerhoorn J, Schonck FMJF, van der Stam JA, Buise MP, Nienhuijs SW, Bouwman RA. Lessons Learned from Telemonitoring in an Outpatient Bariatric Surgery Pathway-Secondary Outcomes of a Patient Preference Clinical Trial. Obes Surg. 2023 Sep;33(9):2725-2733. doi: 10.1007/s11695-023-06637-9. Epub 2023 Jul 7. | |
| 35063007 | Derived |
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| Scheerhoorn J, van Ede L, Luyer MDP, Buise MP, Bouwman RA, Nienhuijs SW. Postbariatric EArly discharge Controlled by Healthdot (PEACH) trial: study protocol for a preference-based randomized trial. Trials. 2022 Jan 21;23(1):67. doi: 10.1186/s13063-022-06001-9. |