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NOT YET RECRUITING
NCT07587450
PHASE3

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

Sponsor: University Hospital, Toulouse

View on ClinicalTrials.gov

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

Interventions

DRUG

Amoxi Clavulanate

children in the arm NOT

PROCEDURE

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