Same Day Ambulatory Appendectomy (SAMBA)

Centre Hospitalier Universitaire de Nice

Status: Enrolling

Conditions: Appendicitis

Treatments: Procedure: Conventional appendectomy; Procedure: Ambulatory appendectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05691348

21-API-01

Details and patient eligibility

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.

Enrollment: 1,400 estimated patients

Sex: All

Ages: 15 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,400 participants in 2 patient groups

Ambulatory pathway

Experimental group

Treatment:

Procedure: Ambulatory appendectomy

Conventional hospitalisation

Active Comparator group

Treatment:

Procedure: Conventional appendectomy