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Study on Using Gentamicin and Clindamycin to Prevent Abscesses After Surgery for Complicated Appendicitis in Patients

Verified siteRegistered drugNo placebo
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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 condition known as appendicitis, specifically a more severe form called complicated appendicitis. The study aims to explore a treatment method involving a procedure called laparoscopic antibiotic lavage. This involves using two antibiotics, clindamycin and gentamicin, to wash the abdominal area after the removal of the appendix. The goal is to see if this method can reduce the risk of developing an intra-abdominal abscess, which is a collection of pus that can occur after surgery.

The purpose of the study is to evaluate whether this antibiotic wash can lower the chances of getting an abscess by at least 50%. Participants in the study will undergo the standard surgical procedure to remove the appendix, known as a laparoscopic appendectomy, and then receive the antibiotic wash. The study will monitor participants for 30 days after the surgery to check for any signs of an abscess. Additionally, other aspects such as wound infections, the need for further treatment, and overall recovery will be observed for up to 90 days.

This trial is designed to gather information on the effectiveness and safety of using antibiotics in this way. By participating, researchers hope to find a better way to prevent complications after surgery for those with complicated appendicitis. The study is expected to continue until 2027, with recruitment starting in 2025.

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

    Eligibility for participation requires a diagnosis of acute appendicitis, with or without suspicion of complicated appendicitis, and undergoing a laparoscopic appendectomy. Participants must be at least 8 years old and able to provide signed consent.

  2. Step 2

    Surgical procedure

    Undergo a laparoscopic appendectomy. This is a minimally invasive surgery to remove the appendix.

  3. Step 3

    Antibiotic lavage

    After the appendectomy, a laparoscopic antibiotic peritoneal lavage is performed. This involves washing the abdominal cavity with a solution containing gentamicin and clindamycin for 3 minutes. This step aims to reduce the risk of developing an intra-abdominal abscess.

  4. Step 4

    Postoperative monitoring

    Monitor for any signs of postoperative complications, such as intra-abdominal abscess, wound infections, or other surgical complications. This monitoring continues for up to 90 days.

  5. Step 5

    Follow-up assessments

    Attend follow-up appointments to assess recovery and any potential complications. These assessments include checking for wound infections, evaluating the need for further treatment, and monitoring overall health and quality of life.

  6. Step 6

    Completion of study participation

    Participation concludes after the final follow-up assessment, which occurs within 90 days post-surgery. The study aims to evaluate the effectiveness of the antibiotic lavage in reducing the incidence of intra-abdominal abscesses.

Who can join the trial?

7 criteria

  • Patients must be **8 years old or older**.
  • Patients must have a **preoperative diagnosis of acute appendicitis**. This means the doctor has determined that the appendix is inflamed before surgery.
  • Patients can have appendicitis with or without signs of it being **complicated**. Complicated appendicitis means the condition is more severe, possibly with infection spreading.
  • Patients must be undergoing a **laparoscopic appendectomy**. This is a type of surgery where small cuts and a camera are used to remove the appendix.
  • During the surgery, the appendicitis must be confirmed as **complicated**.
  • Patients must be able to **provide a signed written consent form**. This means they agree to participate in the study and understand what it involves.
  • Both **male and female** patients can participate.

Who cannot join the trial?

6 criteria

  • Patients who have a known allergy to the antibiotics used in the study, such as gentamicin or clindamycin. These are medications used to fight infections.
  • Patients who have a history of severe allergic reactions to any medications. An allergic reaction is when your body reacts badly to something, like a rash or trouble breathing.
  • Patients who are pregnant or breastfeeding. This is because the study might affect the baby.
  • Patients who have other serious health conditions that might interfere with the study. This means if you have another illness that could make it hard to see how the study treatment is working.
  • Patients who are unable to follow the study procedures. This means if you can't do what the study asks, like taking medications or attending appointments.
  • Patients who are participating in another clinical trial. This is to make sure the results of this study are clear and not mixed with other treatments.
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Investigated drugs

  • Gentamicin

    is an antibiotic used in this study to help prevent infections. It is applied directly to the abdominal area during surgery to reduce the risk of developing an abscess after the removal of an inflamed appendix.

  • Clindamycin

    is another antibiotic used alongside gentamicin in this trial. It is also applied directly to the abdominal area during surgery. The combination of clindamycin and gentamicin is intended to further decrease the chance of infection and abscess formation after appendectomy.

What is already known about the treatment

  • Gentamicin

    This medication is administered through a laparoscopic procedure as an antibiotic lavage directly into the abdominal cavity. It is currently being studied for its effectiveness in preventing intra-abdominal abscesses following appendectomy in cases of complicated appendicitis. Gentamicin is primarily used for its antibacterial properties, targeting a wide range of bacteria by inhibiting protein synthesis at the molecular level. It belongs to the pharmacological class of aminoglycoside antibiotics.

  • Clindamycin

    This medication is also administered via laparoscopic antibiotic lavage into the abdominal cavity. It is under investigation for its role in reducing the risk of intra-abdominal abscesses after surgery for complicated appendicitis. Clindamycin works by inhibiting bacterial protein synthesis, effectively stopping the growth of bacteria. It is classified as a lincosamide antibiotic.

Investigated diseases

Appendicitis – Appendicitis is an inflammation of the appendix, a small tube attached to the large intestine. It typically begins with pain near the belly button, which then moves to the lower right side of the abdomen. As the inflammation progresses, the pain becomes sharper and more severe. Other symptoms may include nausea, vomiting, and fever. If not treated, the appendix can burst, leading to more serious complications. The condition is most common in people between the ages of 10 and 30.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514850-59-00Estimated enrolment752 patientsSponsorAmsterdam UMC Stichting

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