Same Day Ambulatory Appendectomy (SAMBA)

Last updated: February 8, 2024
Sponsor: Centre Hospitalier Universitaire de Nice
Overall Status: Active - Recruiting

Phase

N/A

Condition

Appendicitis

Treatment

Ambulatory appendectomy

Conventional appendectomy

Clinical Study ID

NCT05691348
21-API-01
  • Ages 15-74
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patients aged 15-74 years
  • BMI ≤ 30 kg/m2
  • Uncomplicated acute appendicitis confirmed by imaging (ultrasound and/or CT and/orMRI)
  • 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 fromthe hospital
  • Residence located less than 20 minutes by car from a health center (hospital orclinic)
  • 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 bothparents or their legal representative
  • Affiliation to a French health insurance scheme or equivalent

Exclusion

Exclusion Criteria:

  • Criteria that exclude ambulatory care such as an ASA score (Physical status score) > 2, severe or uncontrolled comorbidities, severe pulmonary disease includingobstructive sleep apnea, anticoagulation or antiplatelet drug or contraindication toambulatory surgery such as intubation difficulties
  • Presence of active cancer, a malignant hemopathy, drug addiction, coagulopathy,immunosuppressive treatment
  • Non-acute or interval appendectomy, i.e. after antibiotic treatment of a complicatedappendicitis of the plastron or drainage of an appendicular abscess;
  • History of pelvic surgery
  • Vulnerable people: pregnant or breast-feeding women (patients will undergo a pregnancytest: plasmatic β-hCG (human chorionic gonadotropin) or urinary test), adult underguardianship or deprived of freedom. Pregnant women are considered to have a fullstomach, with risk of inhalation at anesthetic induction and represent acontraindication to ambulatory surgery. In addition, the need to perform abdominalsurgery on a pregnant woman requires obstetric monitoring that is difficult toreconcile with management in an outpatient surgery unit (need for obstetric ultrasoundor monitoring).
  • Suspicion of a tumor of the appendix : Mucocele and pseudomyxoma, Carcinoid tumor,Adenocarcinoma of the appendix, Another type of tumor

Study Design

Total Participants: 1400
Treatment Group(s): 2
Primary Treatment: Ambulatory appendectomy
Phase:
Study Start date:
July 17, 2023
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • Hôpitaux Pédiatriques de Nice CHU - Lenval

    Nice, Alpes Maritimes 06200
    France

    Site Not Available

  • CHU de Nice

    Nice, Alpes-Maritimes 06000
    France

    Active - Recruiting

  • CHU de Bordeaux

    Bordeaux, Aquitaine 33076
    France

    Site Not Available

  • CH de Troyes

    Troyes, Aube 10000
    France

    Site Not Available

  • CHU Grenoble Alpes

    La Tronche, Auvergne-Rhône-Alpes 38700
    France

    Active - Recruiting

  • Hôpital Edouard HERRIOT

    Lyon, Auvergne-Rhône-Alpes 69003
    France

    Active - Recruiting

  • CHU de Saint-Etienne - Hôpital Nord

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

    Active - Recruiting

  • CH de Voiron

    Voiron, Auvergne-Rhône-Alpes 38500
    France

    Active - Recruiting

  • APHM Hôpital Nord

    Marseille, Bouches-du-Rhône 13326
    France

    Active - Recruiting

  • Centre Hospitalier d'Auxerre

    Auxerre, Bourgogne-Franche-Comté 89011
    France

    Site Not Available

  • CHU Minjo

    Besançon, Bourgogne-Franche-Comté 25000
    France

    Site Not Available

  • CHU de Rennes

    Rennes, Bretagne 35000
    France

    Site Not Available

  • Hôpital Robert Debré - CHU de Reims

    Reims, Grand Est 51092
    France

    Active - Recruiting

  • Hôpital Beaujon (APHP)

    Clichy, Hauts De Seine 92110
    France

    Site Not Available

  • CHU Amiens-Picardie

    Amiens, Hauts-de-France 80054
    France

    Active - Recruiting

  • Clinique de Saint-Omer

    Blendecques, Hauts-de-France 62575
    France

    Site Not Available

  • HIA Percy

    Clamart, Hauts-de-Seine 92140
    France

    Site Not Available

  • APHP Lariboisière

    Paris, Ile De France 75475
    France

    Active - Recruiting

  • APHP Pitié Salpetrière

    Paris, Ile De France 75013
    France

    Site Not Available

  • Clinique de l'Estrée

    Stains, Ile De France 93240
    France

    Site Not Available

  • CHU de Tours

    Tours, Indre Et Loire 37044
    France

    Site Not Available

  • CHU de Reims

    Reims, Marne 51100
    France

    Site Not Available

  • CH Agen - Nérac

    Agen, Nouvelle-Aquitaine 47923
    France

    Site Not Available

  • CH de Dax

    Dax, Nouvelle-Aquitaine 40107
    France

    Active - Recruiting

  • CHU de Limoges

    Limoges, Nouvelle-Aquitaine 87000
    France

    Site Not Available

  • CH de Mont de Marsan

    Mont-de-Marsan, Nouvelle-Aquitaine 40000
    France

    Active - Recruiting

  • Centre Hospitalier Intercommunale de Fréjus-Saint-Raphaël

    Fréjus, Paca 83600
    France

    Site Not Available

  • CHU d'Angers

    Angers, Pays De La Loire 49933
    France

    Active - Recruiting

  • Hôpital d'Instruction des armées Laveran

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

    Active - Recruiting

  • Hôpital d'Instruction des armées Sainte Anne - BCRM Toulon

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

    Active - Recruiting

  • Clinique du Val d'Ouest

    Ecully, Rhones-Alpes 69130
    France

    Site Not Available

  • Hôpital Avicenne

    Bobigny, Île-de-France 93000
    France

    Active - Recruiting

  • Hôpital Louis-Mourier

    Colombes, Île-de-France 92700
    France

    Site Not Available

  • Hia Begin

    Saint-Mandé, Île-de-France 94160
    France

    Site Not Available

  • Hôpital Cochin APHP

    Paris, 75014
    France

    Site Not Available

  • CHU de La Réunion

    Saint-Denis, La Réunion 97400
    Réunion

    Active - Recruiting

  • CHU de La Réunion

    Saint-Pierre, La Réunion 97448
    Réunion

    Active - Recruiting

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