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

Phase 3

Recruiting

• Conditions: Appendicitis; Surgery - Surgical techniques; Infection - Other infectious diseases; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12620000537954
• Lead Sponsor: niversity of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-01
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified