Same Day Ambulatory Appendectomy (SAMBA)
ConditionAppendicitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-74
SponsorCentre Hospitalier Universitaire de Nice
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Ambulatory appendectomy
- Conventional appendectomy
Treatment groups
1,400 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov