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Patient‑chosen treatment vs routine surgery for adult uncomplicated acute appendicitis: trial of amoxicillin‑clavulanic acid versus appendectomy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adults diagnosed with uncomplicated acute appendicitis, an infection of the appendix that has not spread. Two treatment approaches are examined: surgical removal of the appendix (appendectomy) and a course of oral antibiotics that combines amoxicillin with clavulanic acid. The trial compares a model where patients can choose between these options with a model in which everyone receives surgery.

The purpose is to determine whether allowing patients to choose their treatment reduces feelings of regret about that choice after twelve months. Participants are randomly placed into either the choice group or the surgery‑only group, receive the assigned treatment, and are followed for about a year with regular check‑ups.

During follow‑up, patients answer questions about any regret regarding the initial treatment, report any return of symptoms, and complete a questionnaire about overall quality of life. This information is used to compare the outcomes of the two treatment strategies.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial enrollment

    You attend an initial visit where the study is explained and you give written consent to participate.

  2. Step 2

    Choice between treatment options

    The study offers two possible approaches: antibiotics only or appendectomy (surgical removal of the appendix).

    You are asked to select the option you prefer after receiving information about each.

  3. Step 3

    Decision recording

    Your chosen option is recorded in the study database.

  4. Step 4

    Antibiotic treatment (if selected)

    You begin taking amoxicillin and beta‑lactamase inhibitor tablets.

    The medication contains amoxicillin sodium and clavulanic acid.

    The prescribed dose is 4 g per day taken by mouth.

    The exact schedule (for example, divided doses) and total length of treatment are defined by the study protocol.

  5. Step 5

    Monitoring during antibiotic course (if selected)

    You attend scheduled visits or phone checks to report any side effects or persistent symptoms.

    Additional tests may be performed if the clinician deems them necessary.

  6. Step 6

    Surgical treatment (if selected)

    You are scheduled for an appendectomy within the timeframe set by the study.

    The operation is performed under standard surgical conditions.

  7. Step 7

    Post‑operative care (if surgery performed)

    After surgery you stay in the hospital for observation according to routine practice.

    You receive instructions for wound care, pain management, and activity limits.

  8. Step 8

    Early follow‑up visit

    Approximately 1–2 weeks after starting the chosen treatment, you attend a clinic visit.

    The clinician checks for symptom resolution, wound healing (if surgery), or any medication side effects.

  9. Step 9

    Long‑term follow‑up at 12 months

    You complete a questionnaire that asks whether you regret the initial treatment choice.

    You answer questions about any symptom recurrence, overall quality of life, and complete a standardized regret scale.

    The information is used to assess the primary and secondary outcomes of the study.

Who can join the trial?

8 criteria

  • Be between 18 and 70 years old.
  • Be able to read and understand the study information in the language provided and agree to follow the study procedures.
  • Have internet access at home, a valid email address, and be comfortable completing an online questionnaire.
  • Sign a written informed consent form indicating voluntary participation.
  • Be covered by a French health‑insurance plan.
  • Have a diagnosis of uncomplicated acute appendicitis confirmed by a surgeon using clinical signs, blood tests, and imaging tests such as ultrasound (US), computed tomography (CT) or magnetic resonance imaging (MRI) that show an appendix larger than 6 mm, and must NOT have any of the following:
    • Signs of diffuse peritonitis on physical exam (for example, a stiff or rigid abdomen indicating widespread inflammation).
    • Imaging findings of free air inside the abdomen, a collection of fluid that looks like an abscess, large amounts of fluid throughout the abdomen, or extensive inflammation that spreads to nearby organs or forms a mass around the appendix (called an appendicular plastron).
    • Expect to have surgery (appendectomy) within 24 hours after the diagnosis is made.

Who cannot join the trial?

20 criteria

  • If an imaging test (ultrasound, CT scan, or MRI) shows a small stone called an appendicolith in the appendix, you cannot join the study.
  • If you have had any abdominal or pelvic surgery in the last month, you cannot join.
  • If you are allergic (have a hypersensitivity) to the antibiotics amoxicillin, clavulanic acid, or any penicillin, you cannot join.
  • If you have ever had a severe allergic reaction such as anaphylaxis to other antibiotics in the beta‑lactam family (for example cephalosporins, carbapenems, or monobactams), you cannot join.
  • If you have had yellowing of the skin or liver damage (called icterus) caused by amoxicillin/clavulanic acid, you cannot join.
  • If you are allergic to any of the inactive ingredients (called excipients) listed for the study drug, you cannot join.
  • If you have already been treated for acute appendicitis before, either with antibiotics or with surgery to remove the appendix, you cannot join.
  • If you are currently pregnant or are breast‑feeding, you cannot join.
  • If you are already taking part in another clinical trial or are still in the follow‑up period from a previous trial, you cannot join.
  • If you have a mental or cognitive condition that makes it difficult for you to understand the study information or to give consent, you cannot join.
  • If you are a close family member of the doctor, pharmacist, nurse, or study coordinator who is running the trial, you cannot join.
  • If you are an adult who is under legal guardianship or who is not free (for example, in prison), you cannot join.
  • If an imaging test shows that the appendix is larger than 15 mm in diameter (which may suggest a tumor), you cannot join.
  • If the radiologist suspects a tumor of the appendix (such as a mucocele, pseudomyxoma, neuroendocrine tumor, adenocarcinoma, or any other type), you cannot join.
  • If you have severe infection signs called severe sepsis or septic shock (for example, organ problems, very high lactate levels, or low blood pressure that does not improve with fluids), you cannot join.
  • If you have serious uncontrolled health problems such as advanced liver disease (cirrhosis), heart failure, severe kidney disease (estimated kidney function <60 mL/min), are on dialysis, have an active cancer, blood cancers, or are taking blood‑thinning medicines, you cannot join.
  • If you have had a surgical implant placed within the last 90 days (for example, a pacemaker, joint replacement, mechanical heart valve, or a left ventricular assist device), you cannot join.
  • If you have a weakened immune system (for example, very low white‑blood‑cell count, are taking long‑term immune‑suppressing drugs, steroids, or have AIDS with low CD4 count), you cannot join.
  • If you have a history of inflammatory bowel disease such as Crohn’s disease, ulcerative colitis, or an undefined colitis, you cannot join.
  • If you are currently taking antibiotics for another infection, you cannot join.
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Investigated drugs

Amoxicillin‑clavulanate is an oral antibiotic that combines two medicines: amoxicillin, which kills many types of bacteria, and clavulanic acid, which helps amoxicillin work better against bacteria that might resist it. In this trial, participants who chose the antibiotic option took this medicine to treat uncomplicated appendicitis without surgery. The drug is taken by mouth and is meant to clear the infection and relieve symptoms.

Appendectomy is a surgical procedure in which the surgeon removes the inflamed appendix through an operation. In the trial, participants who chose surgery underwent this standard operation to treat their uncomplicated appendicitis. The goal of the surgery is to eliminate the source of infection and prevent any future complications.

What is already known about the treatment

Amoxicillin and Clavulanic Acid - It is taken by mouth as tablets or liquid, delivering amoxicillin sodium together with clavulanic acid. The combination is a well‑known, widely used drug that appears in standard medical references and many clinical studies. It is mainly used to treat infections such as uncomplicated appendicitis, respiratory, urinary and skin infections, and it works by blocking the bacteria’s ability to build a protective cell wall while clavulanic acid stops the bacteria’s enzymes from breaking down the antibiotic. Therefore it is classified as a penicillin‑type antibiotic with a beta‑lactamase inhibitor.

Investigated diseases

Acute appendicitis - Acute appendicitis is a sudden inflammation of the appendix, a small pouch attached to the large intestine. It typically begins with vague abdominal discomfort that becomes sharper and more localized in the lower right side of the abdomen. As the inflammation progresses, the appendix may swell and fill with pus, causing increasing pain and tenderness. If the condition continues without resolution, the inflamed appendix can become irritated further and may eventually develop a small hole or rupture. This process can lead to the spread of infection within the abdominal cavity, although the description stops before discussing treatment or outcomes.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520783-17-01Estimated enrolment560 patientsSponsorAssistance Publique Hopitaux De Paris

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).