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临床试验/NCT07483775
NCT07483775尚未招募不适用

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

Jessa Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年5月5日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Feasibility of same day discharge with a remote monitoring pathway

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

Remote clinical monitoring

Experimental

Remote clinical monitoring

干预措施: remote clinical monitoring (Device)

Control group

Active Comparator

Control group

干预措施: Control group (Other)

结局指标

主要结局

Feasibility of same day discharge with a remote monitoring pathway

时间窗: 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

时间窗: 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).

次要结局

  • Clinical safety- complications(throughouth the study, an average 3 months after surgery)
  • • Patient Quality of Life(throughout completion of the study, up to 3 months after surgery)
  • • Patient Satisfaction(throughout the completion of the study, 3 months after surgery)
  • Length of stay(throughout hospital stay, an average from 0 to 2 days after surgery)
  • Pain assessment(throughout completion of the study, up to 1 month after surgery)
  • Evaluation of analgesia(throughout completion of the study, up to 1 month after surgery)
  • Clinical safety- readmissions(throughouth the study, an average 3 months after surgery)
  • Clinical safety- unplanned healthcare utilization(throughouth the study, an average 3 months after surgery)
  • Evaluation of implementation(throughout the completion of the study, 3 months after surgery)
  • Evaluation of technology acceptance(throughout the completion of the study, 3 months after surgery)

研究者

发起方
Jessa Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stessel Björn

Prof, Dr

Jessa Hospital

研究点 (1)

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