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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Digestive Emergency; New Pathway; Connected Health
• Intervention / Treatment: Other: ERAS; Other: ROFIM; Other: DEEPSEN; Other: RDS; Other: Get ready; Other: Lumiradx; Other: Digital Surgery

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean Marc Regimbeau, Pr; Phone Number: 33 + 322 088 897; Email: regimbeau.jean-marc@chu-amiens.fr

Study Locations

• France
  • Rouen, France, 76000
    • Recruiting
    • CHU Rouen
  • Salouel, France, 80480
    • Recruiting
    • Centre Hospitalier Universitaire, Amiens
    • Contact: Jean Marc Regimbeau, Pr; Phone Number: 33 + 322 088 897; Email: regimbeau.jean-marc@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; patients included in the CHUAP RAUC + course	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
Active Comparator: Control group 1; patients from CHU Rouen included over the same period as patients from CHUAP benefiting from standard care (RAUC -)	Other: ERAS; ERAS
Active Comparator: Control group 2; patients verifying the inclusion/non-inclusion criteria and from the SNDS over the period from January 1, 2022 to December 31, 2025	Other: ERAS; ERAS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of an unscheduled hospitalization readmission	Occurrence of an unscheduled hospitalization readmission following digestive surgery performed urgently within 30 days	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clavien-Dindo score		30 days
Duration of hospitalization linked to the first admission to perform emergency digestive surgery	Duration of hospitalization linked to the first admission to perform emergency digestive surgery	30 days
Quality of life score	Quality of life assessed by the scores of the different dimensions of the EQ-5D-5L which is a PROMS, at admission	0 day
Quality of Life score	Quality of life assessed by the scores of the different dimensions of the EQ-5D-5L which is a PROMS	30 days
STAI-Y scale	Anxiety assessed by the STAI-Y scale	0 day
Transition to emergency without hospitalization	Transition to emergency without hospitalization	30 days
incremental cost-utility ratio	incremental cost-utility ratio	30 days
incremental cost-effectiveness ratio	incremental cost-effectiveness ratio (cost per readmission avoided)	30 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: University Hospital, Rouen
• Investigators: Principal Investigator: Jean Marc Regimbeau, Pr, CHRU Amiens

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: connected health; digestive emergency; new pathway
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: PI2024_843_0094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No