None listed
Conditions
Brief summary
Appendicitis has usually been treated with an operation (i.e. appendicectomy) for the last 125 years however recent studies have suggested antibiotics may be an effective treatment strategy in a subset of patients. While many recent studies have examined this, only one large rigorous clinical trial has been performed (the 2015 APPAC trial), itself with multiple caveats which limit generalizability to the Australian population. Another large trial, the CODA trial in the United States, also is underway however it too will be difficult to generalise this trial to the Australian setting. We aim to conduct a pilot trial to assess the feasibility and acceptability of a treatment protocol designed to compare antibiotics with laparoscopic appendicectomy for the treatment of mild acute uncomplicated appendicitis. The ultimate goal of this trial would be to perform a large, multi-centre trial in the future.
Interventions
Antibiotics:
All patients will receive intravenous ceftriaxone 1g twice per day and intravenous metronidazole 500mg twice per day, in keeping with the Australian Therapeutic Guidelines for severe intra-abdominal infection secondary to perforated viscus. The patients would be re-evaluated within 12 to 24 hours of receiving the antibiotics and monitored at least daily. At least daily blood test will be performed.
If the patient has not met any failure criteria after 48 hours of treatment with IV
Antibiotics: All patients will receive intravenous ceftriaxone 1g twice per day and intravenous metronidazole 500mg twice per day, in keeping with the Australian Therapeutic Guidelines for severe intra-abdominal infection secondary to perforated viscus. The patients would be re-evaluated within 12 to 24 hours of receiving the antibiotics and monitored at least daily. At least daily blood test will be performed. If the patient has not met any failure criteria after 48 hours of treatment with IV antibiotics (i.e. at least 2 doses of ceftriaxone and 4 doses of metronidazole), the patient will be transitioned to a 5 day course of oral Augmentin DuoForte (amoxicillin 875mg + clavulanic acid 125mg) twice per day as an inpatient or an outpatient. A patient who is hypersensitive or has a documented adverse drug reaction to the study medications will not be recruited for the study. Failure of antibiotic therapy will be at the discretion of the treating physician. The treating physician will have to document the reason for failure: persistent tachycardia, persistent fever, worsening laboratory results (including white blood cell count or CRP), non-resolution or worsening of pain, signs of peritonitis, signs of shock, patient preference to proceed with surgery or other.
Sponsors
Townsville Hospital
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
1. Clinical diagnosis of appendicitis as per treating physician. 2. Radiological evidence of appendicitis on Ultrasound or Computed Tomography scan.
Exclusion criteria
Medical Exclusion Criteria: Age < 18 or > 50 Severe sepsis / septic shock Peritonitis Abdominal surgery within last month Received antibiotics within last week Allergy to study medications (i.e. antibiotic regimen, paracetamol) Comorbidity exclusion criteria 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 Exclusion Criteria Inability/unwilling to return for follow up Inability to provided written informed consent Non-English speaker Aboriginal and Torres Strait Islander heritage 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