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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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519402-12-00
Enrollment
724
Registered
2025-10-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

uncomplicated appendicitis

Brief summary

percentage of treatment-related failures at one year defined as : - secondary surgery, - In surgery group, a normal appendix based on pathology or a complication requiring a new general anaesthesia - Readmissions for suspected appendicitis, emergency room visits related to appendicitis treatment, postoperative infections, adverse effects of antibiotics, adverse effects of anesthesia

Detailed description

Differential cost-utility ratio between the two groups of treatment at one year, Direct Medical costs, and indirect costs (parental absenteeism) descriptions at 1 year, Using consumption data available in SNDS database, describe child care pathways over 5 years : Rehospitalization, appendectomy, Incidence of adverse events at day 30 and at one year in the two groups, and incidence of adverse events due to antibiotics in the NOT group

Interventions

DRUGAMOXICILLINE/ACIDE CLAVULANIQUE PANPHARMA 500 mg/50 mg nourrissons et enfants
DRUG50 mg par ml ENFANTS
DRUG5 mg
DRUGLevmentin 2000 mg/200 mg poudre pour solution pour perfusion

Sponsors

Centre Hospitalier Universitaire De Toulouse
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
percentage of treatment-related failures at one year defined as : - secondary surgery, - In surgery group, a normal appendix based on pathology or a complication requiring a new general anaesthesia - Readmissions for suspected appendicitis, emergency room visits related to appendicitis treatment, postoperative infections, adverse effects of antibiotics, adverse effects of anesthesia

Secondary

MeasureTime frame
Differential cost-utility ratio between the two groups of treatment at one year, Direct Medical costs, and indirect costs (parental absenteeism) descriptions at 1 year, Using consumption data available in SNDS database, describe child care pathways over 5 years : Rehospitalization, appendectomy, Incidence of adverse events at day 30 and at one year in the two groups, and incidence of adverse events due to antibiotics in the NOT group

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026