Feasibility and Health-economic Evaluation of Remote Clinical Monitoring Enabling Same-day Discharge After Bariatric Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: remote clinical monitoring, Control group.
- Who it may be relevant to
- Registry conditions: Roux-en Y Gastric Bypass. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility and Health-economic Evaluation of Remote Clinical Monitoring Enabling Same-day Discharge After Bariatric Surgery: a Randomized Controlled Pilot Feasibility Trial
Overview
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.
Interventions
- Device remote clinical monitoring
Remote clinical monitoring after same day discharge - Other Control group
Control group with overnight stay in hospital
Primary outcome measures
- Feasibility of same day discharge with a remote monitoring pathway [Time frame: throughout completion of the study, an average of one year]
- cost-effectiveness analysis [Time frame: throughout completion of the study, an average of one year]
Secondary outcome measures (11)
- 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]
Eligibility criteria
Inclusion criteria
- 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
- 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)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Belgium · 1 center
- Jessa Hospital — Hasselt
Identifiers
NCT: NCT07483775 · 2025/182