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

NCT07587450 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 724

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Acute Uncomplicated Appendicitis

Interventions

DRUG

Amoxi Clavulanate

children in the arm NOT

PROCEDURE

appendicectomy

children in usual care in arm Surgery

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Olivier ABBO · University Hospital of Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2029-09-01
Completion
2034-09-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07587450 on ClinicalTrials.gov