Status:

RECRUITING

Same Day Ambulatory Appendectomy (SAMBA)

Lead Sponsor:

Centre Hospitalier Universitaire de Nice

Conditions:

Appendicitis

Eligibility:

All Genders

15-74 years

Phase:

NA

Brief 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, r...

Eligibility Criteria

Inclusion Criteria:

  • Patients aged 15-74 years

  • BMI ≤ 35 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 ≤ 18,000G/L AND
    • CRP (C reactive protein) ≤ 60mg/L
  • If pain, calmed by level 3 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

Exclusion Criteria:

  • Criteria that exclude ambulatory care such as an ASA score (Physical status score) > 2, severe or uncontrolled comorbidities, severe pulmonary disease including obstructive sleep apnea, anticoagulation or antiplatelet drug or contraindication to ambulatory 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 complicated appendicitis of the plastron or drainage of an appendicular abscess;
  • History of pelvic surgery
  • Vulnerable people: pregnant or breast-feeding women (patients will undergo a pregnancy test: plasmatic β-hCG (human chorionic gonadotropin) or urinary test), adult under guardianship or deprived of freedom. Pregnant women are considered to have a full stomach, with risk of inhalation at anesthetic induction and represent a contraindication to ambulatory surgery. In addition, the need to perform abdominal surgery on a pregnant woman requires obstetric monitoring that is difficult to reconcile with management in an outpatient surgery unit (need for obstetric ultrasound or monitoring).
  • Suspicion of a tumor of the appendix : Mucocele and pseudomyxoma, Carcinoid tumor, Adenocarcinoma of the appendix, Another type of tumor

Key Trial Info

Start Date :

July 17 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 17 2028

Estimated Enrollment :

1400 Patients enrolled

Trial Details

Trial ID

NCT05691348

Start Date

July 17 2023

End Date

January 17 2028

Last Update

March 31 2026

Active Locations (33)

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Page 1 of 9 (33 locations)

1

Hôpitaux Pédiatriques de Nice CHU - Lenval

Nice, Alpes Maritimes, France, 06200

2

CHU de Nice

Nice, Alpes-Maritimes, France, 06000

3

CHU de Bordeaux

Bordeaux, Aquitaine, France, 33076

4

CH de Troyes

Troyes, Aube, France, 10000

Same Day Ambulatory Appendectomy (SAMBA) | DecenTrialz