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.
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.
Belgium1 site
Jessa Hospital
Hasselt, 3500
Bjorn Stessel, Prof, Dr, +3211339848, bjorn.stessel@jessazh.be
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.
- Conditions
- Roux-en Y Gastric Bypass
- 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 group | Role | What they receive |
|---|---|---|
| Remote clinical monitoring | Experimental | Remote clinical monitoring Receives: Device: remote clinical monitoring |
| Control group | Active comparator | Control group Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
• 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
• 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
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
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
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
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
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
• 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
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
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.
- First posted19 Mar 2026
- Study start5 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Roux-en Y Gastric BypassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stessel Björn, Jessa Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Health-economic Evaluation of Remote Clinical Monitoring Enabling Same-day Discharge After Bariatric Surgery: a Randomized Controlled Pilot Feasibility Trial
- ClinicalTrials.gov ID
- NCT07483775
- Acronym / sponsor ID
- REMABS / 2025/182
- Conditions
- Roux-en Y Gastric Bypass
- Keywords
- feasibility study, remote monitoring, bariatic surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 5 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote clinical monitoring | Experimental | Device: remote clinical monitoringRemote clinical monitoring |
| Control group | Active comparator | Other: Control groupControl group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remote clinical monitoringRemote clinical monitoring after same day discharge | Device | Remote clinical monitoring |
| Control groupControl group with overnight stay in hospital | Other | Control group |
Primary outcome
Feasibility of same day discharge with a remote monitoring pathway
Time frame: throughout completion of the study, an average of one year
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.
cost-effectiveness analysis
Time frame: throughout completion of the study, an average of one year
). 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).
11 secondary outcomes
Clinical safety- complications
Time frame: throughouth the study, an average 3 months after surgery
• Patient Quality of Life
Time frame: throughout completion of the study, up to 3 months after surgery
• Patient Satisfaction
Time frame: throughout the completion of the study, 3 months after surgery
Length of stay
Time frame: throughout hospital stay, an average from 0 to 2 days after surgery
Pain assessment
Time frame: throughout completion of the study, up to 1 month after surgery
Evaluation of analgesia
Time frame: throughout completion of the study, up to 1 month after surgery
Clinical safety- readmissions
Time frame: throughouth the study, an average 3 months after surgery
Clinical safety- unplanned healthcare utilization
Time frame: throughouth the study, an average 3 months after surgery
• Patient Quality of Life
Time frame: throughout completion of the study, up to 3 months after surgery
Evaluation of implementation
Time frame: throughout the completion of the study, 3 months after surgery
Evaluation of technology acceptance
Time frame: throughout the completion of the study, 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.