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Study on Reducing Hospital Stay in Children with Complicated Appendicitis Using Amoxicillin and Clavulanic Acid

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 a condition known as complicated acute appendicitis in children. This condition occurs when the appendix, a small organ attached to the large intestine, becomes severely inflamed and infected, often requiring surgical removal. The study aims to evaluate a new treatment approach called the "Fast Track" strategy, which is designed to help children recover more quickly after surgery and potentially shorten their hospital stay.

The treatment being tested involves the use of medications containing amoxicillin and clavulanic acid. These are antibiotics that help fight infections by killing bacteria or preventing their growth. In this study, these medications are given in two forms: a solution for injection or infusion, and film-coated tablets. The trial will compare this new approach to the standard treatment to see if it is just as effective in preventing complications after surgery, such as infections or other issues that might require further medical attention.

Participants in the study will undergo a surgical procedure called a laparoscopic appendectomy, which is a minimally invasive surgery to remove the appendix. After the surgery, they will receive the study treatment and be monitored for any adverse events, such as infections or complications, for 30 days. The goal is to determine if the Fast Track strategy can safely reduce the length of hospital stays without increasing the risk of complications. This study is important for improving recovery times and overall outcomes for children with complicated acute appendicitis.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and surgery

    Upon joining the study, the patient undergoes an appendectomy using a laparoscopic approach. This is a minimally invasive surgery to remove the appendix.

    The surgery is performed after an intraoperative diagnosis of complicated appendicitis is confirmed.

  2. Step 2

    Postoperative care and medication

    After surgery, the patient receives postoperative care. This includes monitoring for any adverse events such as abdominal abscess, peritonitis, or surgical wound complications.

    The patient is administered amoxicillin and clavulanic acid orally. The dosage is 875 mg of amoxicillin and 125 mg of clavulanic acid in the form of film-coated tablets.

    The medication is taken as prescribed by the healthcare provider, typically twice a day, to prevent infection and aid recovery.

  3. Step 3

    Hospital stay and discharge

    The patient remains in the hospital for a period determined by the healthcare team, based on recovery progress and absence of complications.

    The goal of the study is to evaluate a fast-track therapeutic model that aims to shorten the hospital stay without increasing the risk of adverse events.

  4. Step 4

    Follow-up and monitoring

    After discharge, the patient is monitored for 30 days to track any adverse events such as intra-abdominal abscess, peritonitis, or other complications.

    Regular follow-up appointments are scheduled to ensure the patient's recovery is on track and to address any concerns.

Who can join the trial?

4 criteria

  • Age must be between 2 and 17 years old.
  • Must have a diagnosis of complicated appendicitis during surgery. This means the appendix is inflamed and may have other issues like infection or rupture.
  • Must have had an appendectomy using a laparoscopic approach. This is a surgery to remove the appendix using small cuts and a camera.
  • Must agree to participate in the study and have a signed informed consent. This means you understand the study and agree to be part of it.

Who cannot join the trial?

4 criteria

  • Patients who do not have **complicated acute appendicitis**. This means the appendix is inflamed and has caused more serious issues, like an infection spreading in the abdomen.
  • Patients who are not within the age range specified for the study. The study is for children, so adults cannot participate.
  • Patients who are not undergoing a **laparoscopic appendectomy**. This is a type of surgery where small cuts are made in the belly to remove the appendix using a camera and special tools.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Fast Track is a therapeutic strategy designed to help children recover more quickly after surgery for complicated appendicitis. This approach aims to reduce the length of time children need to stay in the hospital after their surgery. It involves specific postoperative care practices that are intended to speed up recovery while ensuring safety and effectiveness.

What is already known about the treatment

Fast Track Strategy – This approach is not a medication but a therapeutic strategy used postoperatively. It is applied in a hospital setting, specifically for pediatric patients who have undergone laparoscopic appendectomy due to complicated acute appendicitis. The current status in medical literature is under evaluation through clinical trials to determine its effectiveness in reducing hospital stay without increasing adverse events. The main therapeutic indication is to manage recovery after surgery for complicated appendicitis. The mechanism of action involves optimizing postoperative care to enhance recovery speed and reduce complications. It falls under the category of postoperative care strategies rather than pharmacological classification.

Investigated diseases

Complicated Acute Appendicitis – This condition occurs when the appendix, a small pouch attached to the large intestine, becomes inflamed and filled with pus. In complicated cases, the inflammation can lead to a rupture, causing infection to spread within the abdominal cavity. This can result in the formation of an abscess or peritonitis, which is an inflammation of the lining of the abdominal cavity. Symptoms often include severe abdominal pain, fever, and nausea. If not addressed, the infection can lead to further complications such as sepsis. The progression of the disease requires prompt medical attention to prevent worsening of the condition.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2025-520777-39-00Protocol codeIIBSP-FAS-2020-120Estimated enrolment772 patientsSponsorFundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

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