None listed
Conditions
Brief 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.
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 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 t
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.
Sponsors
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
- 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 criteria
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 Radiological Exclusion Criteria - CT / USS evidence of complicated appendicitis (phlegmon, abscess, perforation) - Presence of faecolith - Any radiological suspicion for alternative diagnosis or malignancy
Outcome results
None listed