NCT07483775

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
May 2026Dec 2027

First Submitted

Initial submission to the registry

February 23, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 5, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

February 23, 2026

Last Update Submit

April 21, 2026

Conditions

Keywords

feasibility studyremote monitoringbariatic surgery

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (2)

Remote clinical monitoring

EXPERIMENTAL

Remote clinical monitoring

Device: remote clinical monitoring

Control group

ACTIVE COMPARATOR

Control group

Other: Control group

Interventions

Remote clinical monitoring after same day discharge

Remote clinical monitoring

Control group with overnight stay in hospital

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa Hospital

Hasselt, 3500, Belgium

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Bjorn Stessel, Prof, Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof, Dr

Study Record Dates

First Submitted

February 23, 2026

First Posted

March 19, 2026

Study Start

May 5, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations