About this trial
The majority of children with uncomplicated acute appendicitis may be considered for either a non-operative or an operative management. The antibiotic-first strategy appears effective as an initial treatment in 97% of children with uncomplicated AA (recurrence rate 14%), with Non Operative Treatment (NOT) also leading to less morbidity, fewer disability days, and lower costs than surgery. In this trial, the investigators will compare children randomised in a surgery group with children randomised in a NOT group (antibiotic strategy group). Children have 2 on-site visits (including surgery) in the first 12 days with recording of clinical datas and questionnaires, a phone visit at month 1, month 6, month 12 to collect concomitant treatment, Adverse Event (AE) and complications and parental questionnaires at the end of the study. A Cost-Utility analysis will be performed from the healthcare payer's perspective. The time horizon of the medico economic analysis was one year.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age from 5 to <15 years-old
an increase in the calibre of the appendix, measured at more than 6 mm in diameter and non-compressibility
free fluid, echogenic fat, regional hyperemia
performed in hospital or reviewed by local radiologist investigators if performed outpatient.
Disqualifiers
Ultrasound or CT scan showing one or several stercoliths, a plastron, an abscess or peritonitis
Non-visualization of the appendix at ultrasound or CT scan
Situations contraindicating surgery or anesthesia (patient for whom surgery and anesthesia would pose a life-threatening risk)
Patients who have already received antibiotic therapy for acute appendicitis
Trial design
Parallel
Treatments tested in this trial
Amoxi Clavulanate
Drugchildren in the arm NOT
appendicectomy
Procedure/Surgerychildren in usual care in arm Surgery
Treatment groups
Trial outcomes
Primary outcomes
Percentage of treatment-related failures at one year
readmissions for suspicion of appendicitis, secondary surgery, emergency visits related to appendicitis management, postoperative infections, side effects of antibiotics, adverse events of anesthesia. In surgery group, a normal appendix based on pathology or a complication requiring a new general anaesthesia
Secondary outcomes
Initial success rate
Score of quality of life with the questionnaire EQ-5D-Y-3L for children
0 is the worst score and 1 the better score (it is possible to have very bad values under 0)
Score of of quality of life with the questionnaire EQ-5D-5L for parents
0 is the worst score and 1 the better score (it is possible to have very bad values under 0)
Direct Medical costs, and indirect costs (parental absenteeism) descriptions
Sponsors and contacts
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