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NOT YET RECRUITING
NCT07857252
PHASE2

Patient Choice Between Antibiotics and Appendectomy in Uncomplicated Appendicitis (FRENCH 47 - ALACARTE)

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

The ALACARTE study evaluates a strategy in which patients with acute uncomplicated appendicitis are given the choice between appendectomy and antibiotic therapy alone. The investigators hypothesize that giving patients the choice of treatment could reduce treatment regret without compromising safety, particularly by not increasing the risk of complicated appendicitis.Treatment regret will be assessed one year after the randomization. A public health benefit is also anticipated through cost reduction, as antibiotic therapy alone is expected to be less costly than surgery.

Official title: Shared Decision-making in Uncomplicated Appendicitis: a Pragmatic Randomized Trial Comparing Patient-driven Choice (Antibiotics Only or Appendectomy) With Systematic Appendectomy (FRENCH 47 - ALACARTE Trial)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

560

Start Date

2026-10

Completion Date

2029-11

Last Updated

2026-10-05

Healthy Volunteers

No

Interventions

OTHER

Shared decision-making

Participants receive standardized information and are then allowed to choose between antibiotic therapy alone and appendectomy. Patients who do not express a preference undergo appendectomy.

DRUG

amoxicillin-clavulanate

amoxicillin-clavulanate (PO or IV 1 gx3/day for patients \<90 kg or 1 gx4/day for patients ≥90 kg)

PROCEDURE

Appendectomy

Appendectomy

Locations (1)

Department of digestive and general surgery, APHP Saint-Antoine Hospital City Paris

Paris, France