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

Inclusion Criteria4

Uncomplicated acute appendicitis as deemed by reporting radiologist at time of admission
Clinical diagnosis of appendicitis as per treating physician
Age 18 to 50, both males and females
Able to speak English and consent to follow up

Exclusion Criteria30

Medical
Age < 18 or > 50
Severe sepsis / septic shock / medically unstable as per treating physician
Severe peritonitis (as per treating physician)
Abdominal surgery within last month
Received antibiotics within last week
Allergy to all study antibiotics
Co-morbidities
Pregnancy
Complex diabetes: requiring any medication (e.g. metformin, insulin), ketoacidosis or coma
Immunodeficiency
Ischaemic heart disease, Congestive heart failure, Congenital heart disease
Cardiac surgery or coronary stents
Takin aspirin, antiplatelet, anticoagulant medications
History of bleeding disorders
History of chronic liver disease, cirrhosis, liver failure
Chronic renal insufficiency (eGFR < 40), haemodialysis, peritoneal dialysis, plasmapheresis
Concurrent severe illness requiring hospitalization
Other infection requiring antibiotic treatment
Intravenous drug use (ever)
Cognitive impairment, intellectual disability, severe mental illness
Previous colonic or small bowel surgery
Any active malignancy apart from non-metastatic skin cancer
Logistical
Inability/unwilling to return for follow up
Inability to provided written informed consent
Non-English speaker
CT / USS evidence of complicated appendicitis (phlegmon, abscess, perforation)
Presence of faecolith
Any radiological suspicion for alternative diagnosis or malignancy

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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.