Efficacy of Non Operative Treatment With Amoxicillin/Clavulanic Acid Versus Surgical Treatment in Acute Uncomplicated Appendicitis in Children

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

Promoteur : University Hospital, Toulouse

Titre et résumé fournis en anglais par le registre source, reproduits sans traduction ni interprétation.

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.