An interventional study of remote clinical monitoring and Control group in Roux-en Y Gastric Bypass, sponsored by Jessa Hospital. Not yet recruiting at 1 site in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by Jessa Hospital · Not applicable, Interventional, and Supportive care
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.
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.
Jessa Hospital is the lead sponsor of 85 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Remote clinical monitoring
Device: remote clinical monitoring
Control group
Other: Control group
Remote clinical monitoring after same day discharge
Control group with overnight stay in hospital
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.
Time frame: 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).
Time frame: throughout completion of the study, an average of one year
Clinical safety- complications
Postoperative complications will be classified using the Clavien-Dindo classification system and assessed up to 3 months postoperatively.
Time frame: throughouth the study, an average 3 months after surgery
• Patient Quality of Life
o 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.
Time frame: 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
Time frame: throughout the completion of the study, 3 months after surgery
Length of stay
o 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.
Time frame: throughout hospital stay, an average from 0 to 2 days after surgery
Pain assessment
o 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: throughouth the study, an average 3 months after surgery
• Patient Quality of Life
o 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.
Time frame: 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.
Time frame: 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.
Time frame: throughout the completion of the study, 3 months after surgery
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jessa Hospital