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Efficacy of Non Operative Treatment With Amoxicillin/Clavulanic Acid Versus Surgical Treatment in Acute Uncomplicated Appendicitis in Children
Sponsor: University Hospital, Toulouse
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
5 Years - 14 Years
Study Type
INTERVENTIONAL
Enrollment
724
Start Date
2026-09-01
Completion Date
2034-09-01
Last Updated
2026-05-22
Healthy Volunteers
No
Conditions
Interventions
Amoxi Clavulanate
children in the arm NOT
appendicectomy
children in usual care in arm Surgery
Locations (10)
CHU de Bordeaux - Pellerin
Bordeaux, France
Centre Hopsitalier Universitaire de Grenoble - Hôpital Nord
Grenoble, France
Centre Hospitalier Universitaire de Lille - Hôpital Salengro
Lille, France
Centre Hospitalier Universitaire de Limoges
Limoges, France
AP-HM Hopital Nord
Marseille, France
Centre Hospitalier Universitaire - Hôpital Lapeyronie
Montpellier, France
Centre Hospitalier Universitaire de Nantes - Hôtel-Dieu
Nantes, France
AP-HP Hôpital Trousseau
Paris, France
Centre Hospitalier Régional Universitaire de Rennes
Rennes, France
Centre Hospitalier Universitaire
Toulouse, France