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Recruiting NCT06769438

Effectiveness of the RAUC Pathway in Reducing Unscheduled Hospitalizations After Emergency Digestive Surgery

No phase Interventional Digestive Emergency New Pathway Connected Health

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: ERAS, ROFIM, DEEPSEN, RDS.
Who it may be relevant to
Registry conditions: Digestive Emergency, New Pathway, Connected Health. Basic parameters: from 18 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
France
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

Effectiveness of the Augmented Rehabilitation of Digestive Surgical Emergencies Pathway in Reducing Unscheduled Hospitalizations After Surgery

Overview

The number of emergencies's visits (22 million visits in 2019 in France), the organization of emergencies and the sustainability of the current health system are threatened. In the CHUAP adult emergency department, 60,000 visits were recorded in 2022. Unlike medical emergencies which have structured their care and research activities (heart, brain), and whose organization has demonstrated its general interest for society, digestive surgical emergencies, which involve complex patients (elderly people, comorbidities) , emergency situations and surgical procedures, have never been thought of globally in terms of personalized care and research pathways. Currently, patients treated in emergency are managed without a pre-established optimization program and without a dedicated pathway, where emergency constitutes a major risk factor for postoperative complications. RAUCAMIENS evaluates a new care pathway implemented within the framework of the RHU RAUC : the implementation of the Enhanced rehabilitation after surgery (ERAS) and e-health devices for home monitoring, for patients treated in the emergency room for a digestive pathology. The purpose is to evaluate the effectiveness of the RAUC pathway in reducing the rate of unplanned hospitalization readmission after emergency digestive surgery 30 days postoperative.

Interventions

  • Other ERAS
    ERAS
  • Other ROFIM
    teleexpertise solution connecting extra-hospital and intra-hospital practitioners
  • Other DEEPSEN
    virtual reality headset to reduce anxiety
  • Other RDS
    patch to continuously monitor patients' physiological parameters at home
  • Other Get ready
    digital solution for managing patients at home
  • Other Lumiradx
    taking CRP at home
  • Other Digital Surgery
    recording of the different operating times

Primary outcome measures

  • Occurrence of an unscheduled hospitalization readmission [Time frame: 30 days]
Secondary outcome measures (8)
  • Clavien-Dindo score [Time frame: 30 days]
  • Duration of hospitalization linked to the first admission to perform emergency digestive surgery [Time frame: 30 days]
  • Quality of life score [Time frame: 0 day]
  • Quality of Life score [Time frame: 30 days]
  • STAI-Y scale [Time frame: 0 day]
  • Transition to emergency without hospitalization [Time frame: 30 days]
  • incremental cost-utility ratio [Time frame: 30 days]
  • incremental cost-effectiveness ratio [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

  • Criterion linked to the protocol :

\-- Patient consulted in emergency for a digestive pathology requiring surgery

  • Search criteria:
  • Adult patient (≥ 18 years old),
  • Able to give consent,
  • Affiliation to a social security scheme

Exclusion criteria

  • Criterion linked to the protocol:
  • Patient leaving hospitalization to a convalescent center
  • Patient requiring direct operating room (vital emergency or surgical revision)
  • Patient presenting to the emergency room for a postoperative complication
  • Patient directly admitted to intensive care
  • Search criteria:
  • Pregnant or breastfeeding woman
  • Patient under guardianship, curatorship or deprived of liberty

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 2 centers
  • CHU Rouen — Rouen
  • Centre Hospitalier Universitaire, Amiens — Salouël

Identifiers

NCT: NCT06769438 · PI2024_843_0094

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗