To evaluate whether performing bariatric surgery as outpatient surgery is not inferior to the current treatment based on a combined outcome measure.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Monitoring vital signs of patients after standard bariatric surgery
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective:
To evaluate whether performing bariatric surgery as outpatient surgery is not
inferior to the current treatment based on a combined outcome measure.
Secondary outcome
Secondary objectives:
* To assess Patient satisfaction (on a scale of 1-10) in both groups
* To assess feasibility of outpatient recovery after standard bariatric surgery
by evaluating recruitment rate, adherence to protocol and randomization, and
the amount of missing data.
* To evaluate the percentage and total number of false-positive notifications
from the Healthdot system.
* To evaluate the percentage of missed events (i.e. false negatives) from the
Healthdot system.
* To evaluate the total number of missed minor events from the Healthdot system.
* To evaluate the outcome of patients who choose HD versus patients who were
randomized to HD on a combined outcome measure as defined for the primary
endpoint.
* To compare the number of adverse events in both groups
* To compare the use of pain medication during day of surgery until evening in
both groups.
* To compare the clinical decisions made on basis of remote monitoring with the
Healthdot system, to decisions which also include information from a telephone
consultation
* To evaluate the impact of outpatient recovery after standard bariatric
surgery and the Healthdot on patient and health professional satisfaction
* To evaluate the costs involved with outpatient recovery after standard
bariatric surgery supported by Healthdot.
* To evaluate usability of the visualization of Healthdot data on the Guardian
dashboard.
Background summary
This clinical investigation is a single center patient preference trial in a
tertiary hospital in the Netherlands, designed to compare outcome of outpatient
bariatric surgery enabled by measuring the vital signs heart rate and
respiratory rate by the Healthdot at home to the current treatment. 200
patients will be recruited and can choose whether they receive outpatient
surgery or the regular treatment. Patients in the outpatient group will leave
hospital on the day of surgery. They will wear the Healthdot for 7 days at home
and vital signs will be transmitted to the hospital to monitor recovery.
Study objective
To evaluate whether performing bariatric surgery as outpatient surgery is not
inferior to the current treatment based on a combined outcome measure.
Study design
This is a single center clinical investigation
Intervention
Patients in the active group will receive a Healthdot after surgery and will
leave the Hospital on the same day as surgery took place.
Study burden and risks
For the patients participating in this investigation no direct benefits have
been identified. A potential benefit is that patients who are in the active
group wearing the Healthdot are able to leave hospital one day early which
could potentially lead to a higher patient satisfaction. Assessing patient
satisfaction is one of the endpoints in this study. The only anticipated
adverse device effect is an allergic reaction to the plaster used to locate the
device on the skin of the patient. This is mitigated by excluding patients with
known allergies to these kind of medical adhesives. Sending the patient home on
the same day has been assessed in bariatric surgery in several studies and
risks associated with this are considered low. Though the patients undergo
surgery with the associated risks of this procedure this is not part of the
study and the study does not influence the surgery risks. The placement of the
devices will add some additional burden to the patient not related to her/his
stay in hospital, however this additional burden is low.
High Tech Campus 11
Eindhoven 5656AE
NL
High Tech Campus 11
Eindhoven 5656AE
NL
Listed location countries
Age
Inclusion criteria
- 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.
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 (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)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74503.015.20 |
| Other | Registration will be done before first patient is included in clinical trials.gov. |