Same Day Ambulatory Appendectomy (SAMBA)

Status: Recruiting
Location: See all (31) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The potential benefit of outpatient care for this common digestive emergency is considerable, both for the patients themselves and for the public health system: 1. Optimization of the care pathway, reducing the length of stay in hospital (a major issue in the context of the COVID-19 (coronavirus disease) pandemic) liberating patient beds and staff, and reducing the risk of nosocomial exposure. 2. Improved patient satisfaction compared to waiting for hours in the emergency department due to lack of hospital beds. 3. Non-inferiority of care in an outpatient unit in terms of quality and safety in day hospitalization. 4. Significant decrease in the overall cost of this pathology as a result of a reduction in the hospital stay.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 74
Healthy Volunteers: f
View:

• Patients aged 15-74 years

• BMI ≤ 30 kg/m2

• Uncomplicated acute appendicitis confirmed by imaging (ultrasound and/or CT and/or MRI)

‣ Temperature ≤ 38,1°C and \> 35,5°C

⁃ Appendix diameter \> 6mm and ≤ 15mm

⁃ Without effusion or with only localized peri-appendicular effusion

⁃ Infiltration of peri-appendicular fat without abscess or plastron

⁃ No sign of perforation

⁃ Leukocytes ≤ 15,000G/L AND

⁃ CRP (C reactive protein) ≤ 50mg/L

• If pain, calmed by level 2 analgesic at maximum

• Ambulatory criteria

‣ Availability of monitoring by a relative during the 12 hours after discharge from the hospital

⁃ Residence located less than 20 minutes by car from a health center (hospital or clinic)

⁃ Access to a telephone mobile or fixed in case of problems

• Signature of the written informed consent form by the patient

• If the patient is a minor, signature of the written informed consent form by both parents or their legal representative

• Affiliation to a French health insurance scheme or equivalent

Locations
Other Locations
France
CHU Amiens-Picardie
RECRUITING
Amiens
CHU d'Angers
RECRUITING
Angers
CHU Minjo
NOT_YET_RECRUITING
Besançon
Clinique de Saint-Omer
NOT_YET_RECRUITING
Blendecques
Hôpital Avicenne
RECRUITING
Bobigny
CHU de Bordeaux
NOT_YET_RECRUITING
Bordeaux
HIA Percy
NOT_YET_RECRUITING
Clamart
Hôpital Beaujon (APHP)
NOT_YET_RECRUITING
Clichy
Hôpital Louis-Mourier
NOT_YET_RECRUITING
Colombes
CH de Dax
RECRUITING
Dax
Clinique du Val d'Ouest
NOT_YET_RECRUITING
Écully
CHU Grenoble Alpes
RECRUITING
La Tronche
Hôpital Edouard HERRIOT
RECRUITING
Lyon
APHM Hôpital Nord
RECRUITING
Marseille
Hôpital d'Instruction des armées Laveran
RECRUITING
Marseille
CH de Mont de Marsan
RECRUITING
Mont-de-marsan
CHU de Nice
RECRUITING
Nice
Hôpitaux Pédiatriques de Nice CHU - Lenval
NOT_YET_RECRUITING
Nice
APHP Lariboisière
RECRUITING
Paris
APHP Pitié Salpetrière
NOT_YET_RECRUITING
Paris
Hôpital Cochin APHP
NOT_YET_RECRUITING
Paris
CHU de Reims
NOT_YET_RECRUITING
Reims
Hôpital Robert Debré - CHU de Reims
RECRUITING
Reims
CHU de Rennes
NOT_YET_RECRUITING
Rennes
Hia Begin
NOT_YET_RECRUITING
Saint-mandé
CHU de Saint-Etienne - Hôpital Nord
RECRUITING
Saint-priest-en-jarez
Clinique de l'Estrée
NOT_YET_RECRUITING
Stains
Hôpital d'Instruction des armées Sainte Anne - BCRM Toulon
RECRUITING
Toulon
CHU de Tours
NOT_YET_RECRUITING
Tours
CH de Troyes
NOT_YET_RECRUITING
Troyes
CH de Voiron
RECRUITING
Voiron
Contact Information
Primary
Catherine ARVIEUX
catherine.arvieux@intradef.gouv.fr
04 43 98 52 42
Backup
Damien MASSALOU
massalou.d@chu-nice.Fr
04 92 03 33 13
Time Frame
Start Date: 2023-07-17
Estimated Completion Date: 2026-02
Participants
Target number of participants: 1400
Treatments
Experimental: Ambulatory pathway
Active_comparator: Conventional hospitalisation
Sponsors
Leads: Centre Hospitalier Universitaire de Nice

This content was sourced from clinicaltrials.gov