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Набор скоро начнётся NCT07483775

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

Без фазы С лечением Roux-en Y Gastric Bypass

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: remote clinical monitoring, Control group.
Кому может быть актуально
Состояния в реестре: Roux-en Y Gastric Bypass. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бельгия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство remote clinical monitoring
    Remote clinical monitoring after same day discharge
  • Другое Control group
    Control group with overnight stay in hospital

Первичные конечные точки

  • Feasibility of same day discharge with a remote monitoring pathway [Срок оценки: throughout completion of the study, an average of one year]
  • cost-effectiveness analysis [Срок оценки: throughout completion of the study, an average of one year]
Вторичные конечные точки (11)
  • Clinical safety- complications [Срок оценки: throughouth the study, an average 3 months after surgery]
  • • Patient Quality of Life [Срок оценки: throughout completion of the study, up to 3 months after surgery]
  • • Patient Satisfaction [Срок оценки: throughout the completion of the study, 3 months after surgery]
  • Length of stay [Срок оценки: throughout hospital stay, an average from 0 to 2 days after surgery]
  • Pain assessment [Срок оценки: throughout completion of the study, up to 1 month after surgery]
  • Evaluation of analgesia [Срок оценки: throughout completion of the study, up to 1 month after surgery]
  • Clinical safety- readmissions [Срок оценки: throughouth the study, an average 3 months after surgery]
  • Clinical safety- unplanned healthcare utilization [Срок оценки: throughouth the study, an average 3 months after surgery]
  • • Patient Quality of Life [Срок оценки: throughout completion of the study, up to 3 months after surgery]
  • Evaluation of implementation [Срок оценки: throughout the completion of the study, 3 months after surgery]
  • Evaluation of technology acceptance [Срок оценки: throughout the completion of the study, 3 months after surgery]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Бельгия · 1 центр
  • Jessa Hospital — Hasselt

Идентификаторы

NCT: NCT07483775 · 2025/182

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗