RecruitingPhase 3ACTRN12620000537954

Antibiotics versus key-hole surgery for treatment of acute appendicitis (the TRAIN trial)

Laparoscopic Appendicectomy versus Antibiotics for Imaging Confirmed Acute Uncomplicated Appendicitis: A Multisite Randomised Controlled Trial

Sponsor

University of Queensland

Enrollment

300 participants

Start Date

Mar 1, 2020

Study Type

Interventional

Conditions

Appendicitis

Summary

The traditional treatment for appendicitis is an operation but this has been challenged by other studies in recent years: we will treat some patients with antibiotics alone and see if their appendicitis resolves without an operation.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

Appendicitis — inflammation of the appendix — is one of the most common reasons people need emergency surgery. The standard treatment is keyhole surgery (laparoscopic appendicectomy) to remove the appendix. However, emerging research from other countries suggests that for many patients with uncomplicated appendicitis (where the appendix has not ruptured), a course of antibiotics alone might be just as effective and could allow people to avoid an operation altogether. The TRAIN trial is testing this question in Australian patients, randomly assigning eligible participants to receive either standard keyhole surgery or antibiotic treatment. The study will follow participants over time to see how many people treated with antibiotics recover fully without needing surgery, and whether outcomes are comparable to surgery. You may be eligible if you are between 18 and 50 years old, have been diagnosed with uncomplicated acute appendicitis on imaging (no rupture, abscess, or perforation), are not severely unwell, and can speak English. People with pregnancy, significant underlying health conditions (such as diabetes requiring medication, heart disease, immune problems, liver or kidney disease), or any surgical complication on imaging are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Antibiotics: A minimum 48 hour duration of in-hospital, intravenous antibiotics will be given. Acceptable regimens (based on local guidelines) will be one of the following (all regimen are intraven

Antibiotics: A minimum 48 hour duration of in-hospital, intravenous antibiotics will be given. Acceptable regimens (based on local guidelines) will be one of the following (all regimen are intravenous): - Regimen 1: Piperacillin / Tazobactam 4.5g four times per day - Regimen 2: Ceftriaxone 1-2g one to two times per day + Metronidazole 500mg twice or three times per day - Regimen 3: Ampicillin/amoxicillin 2g six-hourly + Gentamicin (variable dosing as per local guideline) + Metronidazole 500mg twice or three times per day - Regimen 4: Augmentin 1.2G 8-hourly In the event the patient has resolving appendicitis, after 48 hours the patient will be discharged with oral antibiotics. Acceptable regimens include: - Regimen 1: Augmentin Duo Forte 825/125mg twice per day orally - Regimen 2: Trimethoprim/sulfamethoxazole 160/800mg twice per day + Metronidazole 400mg three times per day orally If the patient fails to improve, an operation will be performed and this will be classed as a treatment failure as per the primary end-point.