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NCT05691348
Same Day Ambulatory Appendectomy (SAMBA)
Conditions: Appendicitis
Sex: All
Ages: 15 Years – 74 Years
Phase: NA
Enrollment: 1400
Sponsor: Centre Hospitalier Universitaire de Nice
Location: France
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: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.Improved patient satisfaction compared to waiting for hours in the emergency department due to lack of hospital beds.Non-inferiority of care in an outpatient unit in terms of quality and safety in day hospitalization.Significant decrease in the overall cost of this pathology as a result of a reduction in the hospital stay.
Eligibility Criteria
Inclusion Criteria:Patients aged 15-74 yearsBMI ≤ 30 kg/m2Uncomplicated acute appendicitis confirmed by imaging (ultrasound and/or CT and/or MRI)Temperature ≤ 38,1°C and > 35,5°CAppendix diameter > 6mm and ≤ 15mmWithout effusion or with only localized peri-appendicular effusionInfiltration of peri-appendicular fat without abscess or plastronNo sign of perforationLeukocytes ≤ 15,000G/L ANDCRP (C reactive protein) ≤ 50mg/LIf pain, calmed by level 2 analgesic at maximumAmbulatory criteriaAvailability of monitoring by a relative during the 12 hours after discharge from the hospitalResidence located less than 20 minutes by car from a health center (hospital or clinic)Access to a telephone mobile or fixed in case of problemsSignature of the written informed consent form by the patientIf the patient is a minor, signature of the written informed consent form by both parents or their legal representativeAffiliation to a French health insurance scheme or equivalentExclusion 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 difficultiesPresence of active cancer, a malignant hemopathy, drug addiction, coagulopathy, immunosuppressive treatmentNon-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 surgeryVulnerable 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
Source: ClinicalTrials.gov (NCT05691348). StuddyBuddy aggregates publicly available trial information.