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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age5-14
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age from 5 to <15 years-old

an increase in the calibre of the appendix, measured at more than 6 mm in diameter and non-compressibility

free fluid, echogenic fat, regional hyperemia

performed in hospital or reviewed by local radiologist investigators if performed outpatient.

Disqualifiers

Ultrasound or CT scan showing one or several stercoliths, a plastron, an abscess or peritonitis

Non-visualization of the appendix at ultrasound or CT scan

Situations contraindicating surgery or anesthesia (patient for whom surgery and anesthesia would pose a life-threatening risk)

Patients who have already received antibiotic therapy for acute appendicitis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Amoxi Clavulanate

    Drug

    children in the arm NOT

  • appendicectomy

    Procedure/Surgery

    children in usual care in arm Surgery

Treatment groups

724 Participants
are divided into 2 treatment groups
Group A: Non Operative Treatment GroupExperimental treatment 1 intervention
Group B: Surgery Treatment GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of treatment-related failures at one year

readmissions for suspicion of appendicitis, secondary surgery, emergency visits related to appendicitis management, postoperative infections, side effects of antibiotics, adverse events of anesthesia. In surgery group, a normal appendix based on pathology or a complication requiring a new general anaesthesia

Time frame
12 months

Secondary outcomes

1

Initial success rate

Time frame
Day 12
2

Score of quality of life with the questionnaire EQ-5D-Y-3L for children

0 is the worst score and 1 the better score (it is possible to have very bad values under 0)

Time frame
Day 1, Month 1 and Month 12.
3

Score of of quality of life with the questionnaire EQ-5D-5L for parents

0 is the worst score and 1 the better score (it is possible to have very bad values under 0)

Time frame
Day 1, Month 1 and Month 12.
4

Direct Medical costs, and indirect costs (parental absenteeism) descriptions

Time frame
Month 12

Other outcomes

Sponsors and contacts

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