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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Roux-en Y Gastric Bypass
• Intervention / Treatment: Device: remote clinical monitoring; Other: Control group

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bjorn Stessel, Prof, Dr; Phone Number: 011222107; Email: bjorn.stessel@jessazh.be

Study Locations

• Belgium
  • Hasselt, Belgium, 3500
    • Jessa Hospital
    • Contact: Bjorn Stessel, Prof, Dr; Phone Number: +3211339848; Email: bjorn.stessel@jessazh.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Other: Control group; Control group with overnight stay in hospital
Experimental: Remote clinical monitoring	Device: remote clinical monitoring; Remote clinical monitoring after same day discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	throughout completion of the study, an average of one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical safety- complications	Postoperative complications will be classified using the Clavien-Dindo classification system and assessed up to 3 months postoperatively.	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.	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	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.	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.	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.	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.	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.	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.	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.	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.	throughout the completion of the study, 3 months after surgery

Collaborators and Investigators

• Sponsor: Jessa Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 5, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: feasibility study; remote monitoring; bariatic surgery
• Additional Relevant MeSH Terms: Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: 2025/182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No