Actively Recruiting

Phase Not Applicable
Age: 15Years - 74Years
All Genders
NCT05691348

Same Day Ambulatory Appendectomy (SAMBA)

Led by Centre Hospitalier Universitaire de Nice · Updated on 2026-03-31

1400

Participants Needed

33

Research Sites

235 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Same Day Ambulatory Appendectomy (SAMBA)

Who Can Participate

Age: 15Years - 74Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 15-74 years
  • BMI 64 35 kg/m2
  • Uncomplicated acute appendicitis confirmed by imaging (ultrasound and/or CT and/or MRI) with:
    • Temperature 64 38.16C and > 35.56C
    • Appendix diameter > 6 mm and 64 15 mm
    • No effusion or only localized peri-appendicular effusion
    • Peri-appendicular fat infiltration without abscess or plastron
    • No sign of perforation
    • Leukocytes 64 18,000 G/L and C reactive protein 64 60 mg/L
  • Pain controlled with level 3 analgesic at most
  • Availability of monitoring by a relative during 12 hours after discharge
  • Residence less than 20 minutes by car from a health center
  • Access to a telephone (mobile or fixed)
  • Patient’s written informed consent (or both parents/legal representatives if minor)
  • Affiliation to a French health insurance scheme or equivalent
Not Eligible

You will not qualify if you...

  • ASA score > 2 or severe/uncontrolled comorbidities
  • Severe pulmonary disease including obstructive sleep apnea
  • Use of anticoagulation or antiplatelet drugs or contraindication to ambulatory surgery such as intubation difficulties
  • Presence of active cancer, malignant hemopathy, drug addiction, coagulopathy, or immunosuppressive treatment
  • Non-acute or interval appendectomy after antibiotic treatment for complicated appendicitis
  • History of pelvic surgery
  • Pregnant or breastfeeding women (pregnancy test required)
  • Adult under guardianship or deprived of freedom
  • Suspicion of appendix tumor such as mucocele, pseudomyxoma, carcinoid tumor, adenocarcinoma, or other tumor types

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 33 locations

1

Hôpitaux Pédiatriques de Nice CHU - Lenval

Nice, Alpes Maritimes, France, 06200

Not Yet Recruiting

2

CHU de Nice

Nice, Alpes-Maritimes, France, 06000

Actively Recruiting

3

CHU de Bordeaux

Bordeaux, Aquitaine, France, 33076

Not Yet Recruiting

4

CH de Troyes

Troyes, Aube, France, 10000

Not Yet Recruiting

5

CHU Grenoble Alpes

La Tronche, Auvergne-Rhône-Alpes, France, 38700

Actively Recruiting

6

Hôpital Edouard HERRIOT

Lyon, Auvergne-Rhône-Alpes, France, 69003

Actively Recruiting

7

CHU de Saint-Etienne - Hôpital Nord

Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes, France, 42270

Actively Recruiting

8

CH de Voiron

Voiron, Auvergne-Rhône-Alpes, France, 38500

Actively Recruiting

9

APHM Hôpital Nord

Marseille, Bouches-du-Rhône, France, 13326

Actively Recruiting

10

CHU Minjo

Besançon, Bourgogne-Franche-Comté, France, 25000

Not Yet Recruiting

11

CHU de Rennes

Rennes, Brittany Region, France, 35000

Not Yet Recruiting

12

Hôpital Robert Debré - CHU de Reims

Reims, Grand Est, France, 51092

Actively Recruiting

13

Hôpital Beaujon (APHP)

Clichy, Hauts de Seine, France, 92110

Not Yet Recruiting

14

CHU Amiens-Picardie

Amiens, Hauts-de-France, France, 80054

Actively Recruiting

15

Clinique de Saint-Omer

Blendecques, Hauts-de-France, France, 62575

Not Yet Recruiting

16

HIA Percy

Clamart, Hauts-de-Seine, France, 92140

Not Yet Recruiting

17

CHU de Tours

Tours, Indre Et Loire, France, 37044

Not Yet Recruiting

18

CHU de Reims

Reims, Marne, France, 51100

Not Yet Recruiting

19

CH de Dax

Dax, New Aquitaine, France, 40107

Actively Recruiting

20

CH de Mont de Marsan

Mont-de-Marsan, New Aquitaine, France, 40000

Actively Recruiting

21

Hôpital Cochin APHP

Paris, Paris, France, 75014

Not Yet Recruiting

22

CHU d'Angers

Angers, Pays de la Loire Region, France, 49933

Actively Recruiting

23

Hôpital d'Instruction des armées Laveran

Marseille, Provence-Alpes-Côte d'Azur Region, France, 13384

Actively Recruiting

24

Hôpital d'Instruction des armées Sainte Anne - BCRM Toulon

Toulon, Provence-Alpes-Côte d'Azur Region, France, 83800

Actively Recruiting

25

Clinique du Val d'Ouest

Écully, Rhones-Alpes, France, 69130

Not Yet Recruiting

26

Hôpital Avicenne

Bobigny, Île-de-France Region, France, 93000

Actively Recruiting

27

Hôpital Louis-Mourier

Colombes, Île-de-France Region, France, 92700

Not Yet Recruiting

28

APHP Pitié Salpetrière

Paris, Île-de-France Region, France, 75013

Not Yet Recruiting

29

APHP Lariboisière

Paris, Île-de-France Region, France, 75475

Actively Recruiting

30

Hia Begin

Saint-Mandé, Île-de-France Region, France, 94160

Not Yet Recruiting

31

Clinique de l'Estrée

Stains, Île-de-France Region, France, 93240

Not Yet Recruiting

32

CHU de La Réunion

Saint-Denis, La Réunion, Reunion, 97400

Actively Recruiting

33

CHU de La Réunion

Saint-Pierre, La Réunion, Reunion, 97448

Actively Recruiting

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Research Team

C

Catherine ARVIEUX

CONTACT

D

Damien MASSALOU

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Same Day Ambulatory Appendectomy (SAMBA) | DecenTrialz