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.
Patients aged 18-70 years
Diffuse peritonitis on clinical exam (i.e., rigid abdomen / four quadrant peritonitis);
Surgery expected within 24 hours after diagnosis
Patient able to read and understand the language and content of the study documents and agreeing to adhere to the protocol requirements
Appendicolith visible on radiological tests (US and/or CT and/or MRI)
Appendix diameter >15mm (risk factor of appendicular tumor) visible on radiological tests (US and/or CT and/or MRI)
Suspicion of a tumor of the appendix on the imaging exam ((US and/or CT and/or MRI) by the radiologist: (mucocele, pseudomyxoma, neuroendocrine tumor, adenocarcinoma of the appendix, another type of tumor…)
Evidence of severe sepsis or septic shock (e.g., new presumed sepsis-related organ dysfunction, elevated lactate, and/or fluid unresponsive hypotension)
Parallel
Shared decision-making
Other interventionParticipants receive standardized information and are then allowed to choose between antibiotic therapy alone and appendectomy. Patients who do not express a preference undergo appendectomy.
amoxicillin-clavulanate
Drugamoxicillin-clavulanate (PO or IV 1 gx3/day for patients \<90 kg or 1 gx4/day for patients ≥90 kg)
Appendectomy
Procedure/SurgeryAppendectomy
Regret about the initial treatment
The presence of regret about the initial treatment will be evaluated through a specific questionnaire completed online by the patient. The question will be: "You were initially treated for your appendicitis (infection of the appendix) either by surgery with removal of the appendix (appendectomy) or by antibiotic therapy alone without surgery initially. Do you regret the treatment you received? YES - NO." The surgeon will be blinded to the answer.
Patient's symptom persistence or recurrence
Proportion of patients with at least one symptom persistence or recurrence at 12 months : Symptom persistence defined by participants who report the persistence of significant abdominal pain (≥4 with intensity quantified using the numeric pain rating scale from 0 to 10), the persistence of a perceived or measured fever \> 38.0°C, or the persistence of chills.
Patient's quality of life at 12 months.
Quality of life assessed by the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). questionnaire using the French value set for scoring heath states and fulfilled by the participants (Responses are recorded on a 5-point scale: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, and 5 = extreme problems or unable to perform the activity.)
Regret concerning the treatment received
The regret at 12 months assessed by the validated decisional regret scale. This standardized scale allows quantifying treatment regret by a score ranging from 0 for no regret to 100 for maximum regret.
Diagnosis of a complicated AA
Complicated AA is defined by a localized or diffuse peritonitis, abscessed appendicitis, necrotized appendicitis or appendicular plastron as determined by the surgeon through intraoperative findings or through clinical examination and abdominal imaging (CT-scan or MRI or abdominal US) in case of non-surgical management.
Patient's regret
assessed by the answer at the question : " : "You were initially treated for your appendicitis (infection of the appendix) either by surgery with removal of the appendix (appendectomy) or by antibiotic therapy alone without surgery initially. Do you regret the treatment you received? YES - NO."
Treatment regret assessed by the validated decisional regret scale.
This standardized scale allows quantifying treatment regret by a score ranging from 0 for no regret to 100 for maximum regret.
Persistence of appendicitis-related symptoms assessed by abdominal pain, fever, or chills
Symptom's persistence defined by participants who report the persistence of a significant abdominal pain (≥4 with intensity quantified using the numeric pain rating scale from 0 to 10), the persistence of a perceived or measured fever \> 38.0°C, or the persistence of chills.
Patient's quality of life assessed by the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) at 1 month and 6 months
Quality of life assessed by the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). questionnaire using the French value set for scoring heath states and fulfilled by the participants (Responses are recorded on a 5-point scale: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, and 5 = extreme problems or unable to perform the activity.)
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