Antibiotics versus key-hole surgery for successful treatment of acute appendicitis

Phase 3

Recruiting

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

• Registration Number: ACTRN12618001229268
• Lead Sponsor: Townsville Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-23
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from appendicectomy within 6 weeks (antibiotic group). The patient will be reviewed in the outpatient department to ascertain if surgery has been required. If the patient fails to attend, they will be contacted by phone. If the investigators are unable to contact the patient, their state-wide electronic health record will be interrogated (The Viewer).[6 weeks post discharge from hospital.];Successful appendicectomy (surgical group); that is successful appendicectomy with laparoscopic surgery and discharge as per the medical record and operation report. If open surgery, repeat surgery, interventional radiology procedures or prolonged antibiotics are required (e.g. for abscess), surgery will be deemed a failure.[Successful laparoscopic surgery and discharge without re-admission for further surgery or antibiotics 6 weeks following discharge. ]