Efficacy of non operative treatment with amoxicillin/clavulanic acid versus surgical treatment in acute uncomplicated appendicitis in children: a prospective multicenter randomized controlled non-inferiority trial with cost utility analysis

Condition studied

uncomplicated appendicitis

Investigational medicinal product(s)

Eligibility

Primary endpoint

percentage of treatment-related failures at one year defined as : - secondary surgery, - In surgery group, a normal appendix based on pathology or a complication requiring a new general anaesthesia - Readmissions for suspected appendicitis, emergency room visits related to appendicitis treatment, postoperative infections, adverse effects of antibiotics, adverse effects of anesthesia

Endpoint detail

Differential cost-utility ratio between the two groups of treatment at one year, Direct Medical costs, and indirect costs (parental absenteeism) descriptions at 1 year, Using consumption data available in SNDS database, describe child care pathways over 5 years : Rehospitalization, appendectomy, Incidence of adverse events at day 30 and at one year in the two groups, and incidence of adverse events due to antibiotics in the NOT group