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Study on Post-Surgery Antibiotic Use in Patients with Complicated Acute Appendicitis: Evaluating Metronidazole, Ceftriaxone, and Ofloxacin Hydrochloride

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What is this trial about?

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

This clinical trial is focused on studying the effects of post-operative antibiotic therapy in patients who have undergone a laparoscopic appendectomy for a condition known as complicated acute appendicitis. This condition involves inflammation of the appendix that may include complications such as a perforated appendix, which means the appendix has burst, or the presence of abscesses, which are collections of pus. The study aims to evaluate the impact of not using antibiotics after surgery on the rate of infections that occur in the area of the surgery.

The trial involves several medications, including metronidazole, glucose, ceftriaxone sodium, lidocaine hydrochloride, and ofloxacin hydrochloride. These medications are administered through infusion, which means they are given directly into the bloodstream. The study also includes a group that receives a placebo, which is a substance with no active medication, to compare the effects of the antibiotics.

Participants in the study will be monitored for a period of up to three days after their surgery. The main focus is to observe the occurrence of infections at the surgical site within 30 days after the operation. Additionally, the study will look at other factors such as the quality of life before and after surgery, the number of days without antibiotics, and the balance between antibiotic use and resistance to bacteria. The goal is to understand whether antibiotics are necessary after surgery for this type of appendicitis and to ensure the best outcomes for patients.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after a laparoscopic appendectomy for complicated acute appendicitis is performed. This condition is confirmed during surgery by the presence of a perforated appendix, extraluminal fecaliths, abscesses, or localized peritonitis.

    Eligibility requires being 18 years or older and having signed an informed consent form.

  2. Step 2

    Randomization

    Participants are randomly assigned to either receive post-operative antibiotic therapy or not. This is to evaluate the impact of not using antibiotics on the rate of infections at the surgical site.

  3. Step 3

    Treatment phase

    If assigned to the antibiotic group, medications may include metronidazole, ceftriaxone, sodium chloride, and levofloxacin. These are administered through infusion.

    The specific dosage, frequency, and duration of administration are determined by the study protocol and medical team.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for signs of infection and other health indicators for 30 days after surgery.

    The primary focus is on the occurrence of deep surgical site infections, which are infections that affect the area around the surgical site.

  5. Step 5

    Evaluation of outcomes

    The study evaluates the quality of life before surgery and upon discharge using specific questionnaires.

    Other outcomes include the rate of superficial infections, the number of days without antibiotics, and the balance between antibiotic use and microbial resistance.

  6. Step 6

    Completion of study participation

    Participation concludes after the 30-day post-operative period, with a final assessment of health outcomes and any potential rehospitalization.

Who can join the trial?

4 criteria

  • The patient must have **complicated acute appendicitis** confirmed during surgery. This means the appendix is perforated, there are fecaliths (small stones made of feces) outside the appendix, abscesses (pockets of pus), or **localized peritonitis** (infection in one or two areas of the abdomen).
  • The patient must have had a **laparoscopic appendectomy**, which is a surgery to remove the appendix using small cuts and a camera.
  • The patient must be **18 years or older**.
  • The patient must have signed an **Informed Consent Form (ICF)**, which means they agree to participate in the study after understanding what it involves.

Who cannot join the trial?

3 criteria

  • Patients with **generalized peritonitis** cannot participate. This is a condition where there is widespread inflammation in the lining of the abdomen.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.
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Investigated drugs

Antibiotic Therapy is used in this clinical trial to treat patients after they have undergone a laparoscopic appendectomy for complicated acute appendicitis. The study is evaluating the impact of not using antibiotics after surgery to see if it affects the rate of infections at the surgical site.

What is already known about the treatment

Antibiotic Therapy – This medication is typically administered orally or intravenously, depending on the specific antibiotic and the patient's condition. In the context of the clinical trial, it is being evaluated for its necessity after laparoscopic appendectomy for complicated acute appendicitis. Antibiotics are commonly used to prevent infections, but this study aims to determine if they are needed post-surgery in certain cases. The mechanism of action involves targeting and killing bacteria or inhibiting their growth, depending on the type of antibiotic. They are classified as antimicrobial agents and are a cornerstone in treating bacterial infections.

Investigated diseases

Complicated Acute Appendicitis – This condition occurs when the appendix, a small pouch attached to the large intestine, becomes inflamed and infected, leading to a more severe form of appendicitis. It is characterized by the presence of complications such as perforation, abscess, or peritonitis, which is an inflammation of the lining of the abdominal cavity. The disease typically begins with abdominal pain, often starting around the navel and then shifting to the lower right side. As the condition progresses, symptoms may include fever, nausea, vomiting, and an increase in pain intensity. If not treated promptly, the appendix can rupture, leading to widespread infection in the abdomen.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515834-34-00Protocol codePI2017_843_0002Estimated enrolment1 494 patientsSponsorCentre Hospitalier Universitaire Amiens Picardie

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