NCT06769438

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
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 Progress43%
Jun 2025Aug 2027

First Submitted

Initial submission to the registry

January 7, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

June 2, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

1.4 years

First QC Date

January 7, 2025

Last Update Submit

June 11, 2025

Conditions

Keywords

digestive emergencynew pathwayconnected health

Outcome Measures

Primary Outcomes (1)

  • Occurrence of an unscheduled hospitalization readmission

    Occurrence of an unscheduled hospitalization readmission following digestive surgery performed urgently within 30 days

    30 days

Secondary Outcomes (8)

  • Clavien-Dindo score

    30 days

  • Duration of hospitalization linked to the first admission to perform emergency digestive surgery

    30 days

  • Quality of life score

    0 day

  • Quality of Life score

    30 days

  • STAI-Y scale

    0 day

  • +3 more secondary outcomes

Study Arms (3)

Experimental group

EXPERIMENTAL

patients included in the CHUAP RAUC + course

Other: ERASOther: ROFIMOther: DEEPSENOther: RDSOther: Get readyOther: LumiradxOther: Digital Surgery

Control group 1

ACTIVE COMPARATOR

patients from CHU Rouen included over the same period as patients from CHUAP benefiting from standard care (RAUC -)

Other: ERAS

Control group 2

ACTIVE COMPARATOR

patients verifying the inclusion/non-inclusion criteria and from the SNDS over the period from January 1, 2022 to December 31, 2025

Other: ERAS

Interventions

ERASOTHER

ERAS

Control group 1Control group 2Experimental group
ROFIMOTHER

teleexpertise solution connecting extra-hospital and intra-hospital practitioners

Experimental group
DEEPSENOTHER

virtual reality headset to reduce anxiety

Experimental group
RDSOTHER

patch to continuously monitor patients' physiological parameters at home

Experimental group

digital solution for managing patients at home

Experimental group

taking CRP at home

Experimental group

recording of the different operating times

Experimental group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Rouen

Rouen, 76000, France

RECRUITING

Centre Hospitalier Universitaire, Amiens

Salouël, 80480, France

RECRUITING

Study Officials

  • Jean Marc Regimbeau, Pr

    CHRU Amiens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2025

First Posted

January 10, 2025

Study Start

June 2, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

August 1, 2027

Last Updated

June 13, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations