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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)
EU CTIS ID: 2025-520783-17-01
What this study is testing
To evaluate whether allowing patient to choose between appendectomy and antibiotics for uncomplicated AA reduces treatment regret at 12 months compared to a systematic appendectomy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Patients aged 18-70 years
- 4. Patient able to read and understand the language and content of the study documents and agreeing to adhere to the protocol requirements
- 5. Patient with internet access at home and a valid email address who declares being able to complete an online questionnaire
- 6. Signature of the written informed consent form by the patient
- 7. Affiliation to a French health insurance scheme
- 2. 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::
You likely can't join if
- 1. Appendicolith visible on radiological tests (US and/or CT and/or MRI)
- 10. Abdominal/pelvic surgery in the past month
- 11. Hypersensitivity to Amoxicillin, clavulanic acid and penicillins
- 12. History of severe immediate hypersensitivity reaction (e.g., anaphylaxis) to another beta-lactam (e.g., a cephalosporin, carbapenem, or monobactam).
- 13. History of icterus/liver damage related to amoxicillin/clavulanic acid
- 14. Allergy to any of the excipients listed in section 6.1 of SmPC
See the full eligibility criteria
Who can join
- 1. Patients aged 18-70 years
- 4. Patient able to read and understand the language and content of the study documents and agreeing to adhere to the protocol requirements
- 5. Patient with internet access at home and a valid email address who declares being able to complete an online questionnaire
- 6. Signature of the written informed consent form by the patient
- 7. Affiliation to a French health insurance scheme
- 2. 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::
- a. Diffuse peritonitis on clinical exam (i.e., rigid abdomen / four quadrant peritonitis).
- b. Radiologic findings of:
- Free air
- Walled off fluid collection concerning for an abscess;
- Significant amounts of intra-abdominal fluid throughout abdomen (i.e., more than trace fluid)
- Extent of inflammation or adjacent organ involvement or appendicular plastron on radiologic imaging
- 3. Surgery expected within 24 hours after diagnosis
What rules you out
- 1. Appendicolith visible on radiological tests (US and/or CT and/or MRI)
- 10. Abdominal/pelvic surgery in the past month
- 11. Hypersensitivity to Amoxicillin, clavulanic acid and penicillins
- 12. History of severe immediate hypersensitivity reaction (e.g., anaphylaxis) to another beta-lactam (e.g., a cephalosporin, carbapenem, or monobactam).
- 13. History of icterus/liver damage related to amoxicillin/clavulanic acid
- 14. Allergy to any of the excipients listed in section 6.1 of SmPC
- 15. History of AA treated by antibiotics or appendectomy
- 16. Pregnant* or breast-feeding women
- 17. Participation in another interventional study or being in the exclusion period at the end of a previous study.
- 18. Mental or cognitive impairment rendering the patient unable to understand study information or to provide informed consent.
- 19. Patient being a relative of the investigator or of a member of the research team directly involved in the trial (assistant doctors, pharmacists, nurses, or study coordinators).
- 2. Appendix diameter >15mm (risk factor of appendicular tumor) visible on radiological tests (US and/or CT and/or MRI)
- 20. Adult under guardianship or deprived of freedom
- *A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- 3. 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…)
- 4. Evidence of severe sepsis or septic shock (e.g., new presumed sepsis-related organ dysfunction, elevated lactate, and/or fluid unresponsive hypotension)
- 5. 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
- 6. Recent (within 90 days) placement of surgical implant (e.g., pacemaker, joint prosthesis, mechanical valve) or indwelling Left Ventricular Assist Device
- 7. 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)
- 8. History of inflammatory bowel disease (Crohn disease, or ulcerative colitis or indeterminate colitis)
- 9. Ongoing antibiotic therapy for another infection
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.