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

NCT07857252 | Not Yet Recruiting Phase 2

• 3 other identifiers: APHP2409132025-520783-17-012025
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Appendicitis

Keywords

Acute uncomplicated appendicitis; Appendectomy; Patient preference; Treatment choice; Regret; Antibiotic therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  12 month after the randomization

Secondary Outcomes (10)

• Patient's symptom persistence or recurrence

  at 12 months

• Patient's quality of life at 12 months.

  at 12 months

• Regret concerning the treatment received

  at 12 months

• Diagnosis of a complicated AA

  within 12 months after randomization

• Positive bacteriological examination of intrabdominal fluid harvested during surgery

  during surgery

Other Outcomes (12)

• Patient's regret

  at 1 and 6 months

• Treatment regret assessed by the validated decisional regret scale.

  at 1 and 6 months

• Persistence of appendicitis-related symptoms assessed by abdominal pain, fever, or chills

  at 1 and 6 months

Study Arms (2)

Intervention arm : Patient preference treatment

EXPERIMENTAL

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.

Other: Shared decision-making; Drug: amoxicillin-clavulanate; Procedure: Appendectomy

Control arm : Appendectomy

ACTIVE COMPARATOR

Participants undergo appendectomy as the standard treatment for acute uncomplicated appendicitis

Procedure: Appendectomy

Interventions

Shared decision-making OTHER

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.

Intervention arm : Patient preference treatment

amoxicillin-clavulanate DRUG

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

Also known as: amoxicillin-clavulanic acid

Intervention arm : Patient preference treatment

Appendectomy PROCEDURE

Appendectomy

Control arm : Appendectomy; Intervention arm : Patient preference treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-70 years
• Diagnosis of uncomplicated AA established by the investigator surgeon that relies on clinico-biological suspicion of acute AA confirm by care radiological tests (US and/or CT and/or MRI) including appendix diameter \>6.0mm. and without:
• Diffuse peritonitis on clinical exam (i.e., rigid abdomen / four quadrant peritonitis);
• Radiologic findings of:
• i. Free air ii. Walled off fluid collection concerning for an abscess iii. Significant amounts of intra-abdominal fluid throughout abdomen (i.e.,more than trace fluid) iv. Extent of inflammation or adjacent organ involvement on radiologic, appendicular plastron on radiologic imaging
• 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
• Patient with internet access at home and a valid email address who declares being able to complete an online questionnaire
• Signature of the written informed consent form by the patient
• Affiliation to a French health insurance scheme

You may not qualify if:

• 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)
• Severe or uncontrolled comorbidities, such as hepatic cirrhosis, heart failure, acute or chronic kidney failure (estimated glomerular filtration rate \<60mL/min), concurrent hemodialysis or peritoneal dialysis, or treatments using indwelling venous catheters, presence of active cancer or a malignant hemopathy, anticoagulant treatments
• Recent (within 90 days) placement of surgical implant (e.g., pacemaker, joint prosthesis, mechanical valve) or indwelling Left Ventricular Assist Device
• Immunodeficiency (e.g., absolute neutrophil count \<500/mm3, chronic immunosuppressive drugs, long term corticosteroids, or known AIDS \[CD4 count \<200/mm3 or AIDS-defining illness assessed by patient history)
• History of inflammatory bowel disease (Crohn disease, or ulcerative colitis or indeterminate colitis)
• Ongoing antibiotic therapy for another infection
• Abdominal/pelvic surgery in the past month
• Hypersensitivity to Amoxicillin, clavulanic acid and penicillins
• History of severe immediate hypersensitivity reaction (e.g., anaphylaxis) to another beta-lactam (e.g., a cephalosporin, carbapenem, or monobactam).
• History of icterus/liver damage related to amoxicillin/clavulanic acid
• Allergy to any of the excipients listed in section 6.1 of SmPC
• History of AA treated by antibiotics or appendectomy

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

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

Paris, 75012, France

Location

MeSH Terms

Conditions

Appendicitis; Patient Preference

Interventions

Amoxicillin-Potassium Clavulanate Combination; Appendectomy

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Maxime COLLARD

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maxime COLLARD, MD, PhD

CONTACT

+33.6.26.54.86.19; maxime.collard@aphp.fr

Thibault VORON, MD, PhD

CONTACT

+33.6.65.68.83.30; thibault.voron@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Investigators are blinded to the patients' responses to the self-administered questionnaires
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: ALACARTE trial is a prospective multicenter open-label randomized, superiority clinical trial in two parallel arms (1:1 ratio)

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: October 5, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: October 5, 2026

Record last verified: 2026-09

Locations

FR (1)