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Roux-en Y Gastric BypassREMABSNCT07483775

Feasibility and Health-economic Evaluation of Remote Clinical Monitoring Enabling Same-day Discharge After Bariatric Surgery

A study testing remote clinical monitoring in people with Roux-en Y Gastric Bypass, run by Jessa Hospital at 1 site in Belgium.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The ultimate goal of this research is to optimize care for patients undergoing laparoscopic bariatric surgery while alleviating pressure on hospital resources and staff. Furthermore, the study aims to generate policy-relevant data that can inform policymakers and healthcare providers in developing funding models and… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Roux-en Y Gastric Bypass
What is being tested?
remote clinical monitoring
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBelgium
Study dates
5 May 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-65 years old
  • Undergoing scheduled ambulatory Roux en Y Gastric Bypass
  • ASA score I or II
  • Competent to provide informed consent
  • Surgery is planned in the morning
  • Fluent in Dutch
Show all 9Show fewer
  • Owning a smartphone or having a caregiver who can assist
  • Cognitively capable of understanding the study and using the remote wearables
  • An informal caregiver is available following hospital discharge, more specifically during the remainder of the day of surgery (Postoperative day POD 0 and throughout POD 1)

Who cannot join

  • Presence of coagulation abnormalities or use of anticoagulant therapy
  • History of major abdominal surgeries, including laparotomy
  • Absence of informed consent or request not to participate in the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bjorn Stessel, Prof, Dr contact

011222107

bjorn.stessel@jessazh.be

Belgium1 site
  • Jessa Hospital

    Hasselt, 3500

    Bjorn Stessel, Prof, Dr, +3211339848, bjorn.stessel@jessazh.be

Other trials in Belgium

About this study

Official title: Feasibility and Health-economic Evaluation of Remote Clinical Monitoring Enabling Same-day Discharge After Bariatric Surgery: a Randomized Controlled Pilot Feasibility Trial

The ultimate goal of this research is to optimize care for patients undergoing laparoscopic bariatric surgery while alleviating pressure on hospital resources and staff. Furthermore, the study aims to generate policy-relevant data that can inform policymakers and healthcare providers in developing funding models and care pathways that balance safety, efficiency, and cost-effectiveness. This could support a broader implementation of ambulatory bariatric surgery without compromising quality of care.

Read the detailed description

Obesity affects over one billion people worldwide and continues to increase . Bariatric surgery, especially laparoscopic Roux-en-Y gastric bypass (RYGB), is an effective treatment for severe obesity and related health issues. Over the last decade, gastric bypass surgery has been performed more frequently through laparoscopic RYGB than open surgery. This minimally invasive alternative offers less postoperative pain, a quicker recovery, a shorter hospital stay, decreased morbidity, reduced intraoperative blood loss, and reduced healthcare costs. Traditionally, these surgeries require hospital stays, but there is growing interest in optimizing care pathways to improve recovery and reduce hospital resource utilization.

While same-day discharge (SDD) protocols aim to minimize hospital stay, concerns remain about patient safety after early discharge. Without continuous monitoring, early signs of complications such as bleeding, infection, or respiratory distress may be missed or detected too late, potentially leading to emergency readmissions or worse outcomes. Remote monitoring technologies offer the potential to address this gap by enabling real-time surveillance of vital signs, thus allowing for earlier detection of complications and timely interventions.

Enhanced Recovery After Surgery (ERAS) protocols have established guidelines that outline improved perioperative care by promoting early post-surgical mobilization, a multimodal approach to analgesia, and the prevention of postoperative nausea. These improvements have made SDD after bariatric surgery possible and have shown promising feasibility and safety in select patient groups. However, most evidence comes from specialized centers under controlled conditions, and the broad implementation of SDD remains limited.

One key challenge in the broader adoption of SDD is ensuring patient safety after discharge. Although remote monitoring appears promising, its added value in the specific context of ambulatory bariatric surgery remains insufficiently studied. It remains unclear whether this technology improves outcomes, adherence, or patient satisfaction compared to current care pathways.

Despite the possible benefits of outpatient procedures, the transition from inpatient to outpatient care poses significant challenges in many healthcare systems. In Belgium, for example, SDD bariatric surgery can lead to substantial reductions in hospital reimbursement, creating a financial disincentive for hospitals to implement SDD pathways. This situation highlights the urgent need for robust data demonstrating the feasibility, safety, and economic implications of SDD combined with remote monitoring in bariatric surgery.

This pilot study aims to investigate the use of a wearable patient monitoring system (mWearTM, Mindray©) for SDD combined with continuous remote monitoring of patients after minimally invasive RYGB in a Belgian healthcare context. The wearables will be connected to a platform that measures vital signs, including heart rate, respiratory rate, blood pressure, body temperature, and oxygen saturation. All data will be displayed on a dashboard (BeWell), enabling 24/7 patient monitoring by a care center, Z-plus, which will serve as the telemonitoring hub. After discharge, parameters will be continuously measured and are forwarded to the BeWell platform hourly, with follow-up via the BeWell mobile application for the administration of questionnaires and tailored recovery advice via push notifications, as well as video contact by Z-plus which is foreseen up to and including Post Operative Day 1 (POD 1). Patients are also given a personal alarm to take home. Z-plus will screen all input from the BeWell mobile application, as well as the parameters that are obtained via the wearable monitoring system. Interventions will be initiated if alarming values are detected. This study aims to assess the feasibility of implementing this care model. Additionally, a health-economic analysis will be conducted.

Being tested
remote clinical monitoring, Control group
Keywords
feasibility study, remote monitoring, bariatic surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • remote clinical monitoringDevice

    Remote clinical monitoring after same day discharge

  • Control groupOther

    Control group with overnight stay in hospital

Study groups in NCT07483775
Study groupRoleWhat they receive
Remote clinical monitoringExperimentalRemote clinical monitoring
Receives: Device: remote clinical monitoring
Control groupActive comparatorControl group
Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of same day discharge with a remote monitoring pathway

    The primary outcome of this study is to assess the feasibility of a SDD care pathway with remote monitoring for patients undergoing laparoscopic RYGB in an ambulatory setting.

    Measured: throughout completion of the study, an average of one year

  2. cost-effectiveness analysis

    ). The CEA will result in an incremental cost-effectiveness ratio (ICER), which is the ratio of the incremental costs of the remote monitoring program to incremental health gains of the program compared to the standard care. The analysis will be performed from a societal perspective, meaning that all relevant costs will be included, irrespective of who pays for the costs (patient, hospital, or RIZIV).

    Measured: throughout completion of the study, an average of one year

Secondary outcomes (11)
  1. Clinical safety- complications

    Postoperative complications will be classified using the Clavien-Dindo classification system and assessed up to 3 months postoperatively.

    Measured: throughouth the study, an average 3 months after surgery

  2. • Patient Quality of Life

    • Evaluated using the EQ-5D questionnaires.
    • In the intervention group, patients will receive these questionnaires digitally through the BeWell application. The frequency of questionnaire administration will be increased to daily during the first 7 postoperative days, and subsequently at 2 weeks, 1 month, 6 weeks, 2 months, and 3 months after surgery (17,18).
    • In the control group, questionnaires will be administered in person during their hospital stay or by telephone after discharge. Questionnaires will be administered at 1 day, 7 days, 1 month, 2 months, and 3 months after surgery.

    Measured: throughout completion of the study, up to 3 months after surgery

  3. • Patient Satisfaction

    Patient Satisfaction will be measured after 3 months using a 7-point Likert scale and 11-point Numeric Rating Scale (NRS 0-10) to assess satisfaction with the care pathway, feelings of safety, and sufficiency of recovery advice/follow-up information

    Measured: throughout the completion of the study, 3 months after surgery

  4. Length of stay

    • Duration of Hospital Stay: The total number of hours from surgery to discharge will be recorded, with hospital admission and discharge data systematically collected for both groups.

    Measured: throughout hospital stay, an average from 0 to 2 days after surgery

  5. Pain assessment

    • Pain assessment: both pain at rest and pain at movement will be measured using 11-point Numeric Rating Scales (NRS) at the PACU, and at 1 day, 2 days, 7 days, and 1 month post-surgery.

    Measured: throughout completion of the study, up to 1 month after surgery

  6. Evaluation of analgesia

    Evaluation of analgesia by the pain medication used: assessment of the type, dose, and frequency of painkillers taken by collecting the number and type of painkillers taken, assessed once a day from the moment of discharge until the morning of POD 2 via telephone call for the intervention group or via in-hospital assessment for the control group.

    Measured: throughout completion of the study, up to 1 month after surgery

  7. Clinical safety- readmissions

    Unplanned readmissions:

    Any unplanned hospital readmission occurring within 3 months after surgery.

    Measured: throughouth the study, an average 3 months after surgery

  8. Clinical safety- unplanned healthcare utilization

    Unplanned healthcare utilization:

    Any other unplanned medical contact within 3 months after surgery, including emergency department consultations, unscheduled outpatient visits, or home visits by a general practitioner or other physician.

    Measured: throughouth the study, an average 3 months after surgery

  9. • Patient Quality of Life

    • Evaluated using the SF-36 questionnaires.
    • In the intervention group, patients will receive these questionnaires digitally through the BeWell application. The frequency of questionnaire administration will be increased to daily during the first 7 postoperative days, and subsequently at 2 weeks, 1 month, 6 weeks, 2 months, and 3 months after surgery (17,18).
    • In the control group, questionnaires will be administered in person during their hospital stay or by telephone after discharge. Questionnaires will be administered at 1 day, 7 days, 1 month, 2 months, and 3 months after surgery.

    Measured: throughout completion of the study, up to 3 months after surgery

  10. Evaluation of implementation

    Implementation will be evaluated using the AIM (Acceptability of Intervention Measure), IAM (Intervention Appropriateness Measure), and FIM (Feasibility of Intervention Measure) at 1 month and 3 months post-surgery to assess the acceptability, appropriateness, and feasibility of the wearable devices.

    Measured: throughout the completion of the study, 3 months after surgery

  11. Evaluation of technology acceptance

    Technology acceptance will be ssessed using the Telemedicine Perception Questionnaire (TMPQ), adapted to the context of the study and supplemented with some aspects from the Technology Acceptance Model (TAM), the Unified Theory of Acceptance and Use of Technology (UTAUT), and the Theory of Planned Behavior (TPB). This will be evaluated at 7 days, 1 month, and 3 months post-surgery.

    Measured: throughout the completion of the study, 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2026
  2. Study start5 May 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07483775
Sponsor's protocol ID
2025/182
Acronym
REMABS
Status last verified
Apr 2026
First submitted
23 Feb 2026
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing remote clinical monitoring in people with Roux-en Y Gastric Bypass, run by Jessa Hospital at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bjorn Stessel, Prof, Dr (011222107, bjorn.stessel@jessazh.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of same day discharge with a remote monitoring pathway (time frame: throughout completion of the study, an average of one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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