Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis (COMMA)

Beaumont Hospital

Status: Completed

Conditions: Appendicitis

Treatments: Procedure: Laparoscopic +/- Open Appendicectomy; Drug: Antibiotic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02916134

16/59

Details and patient eligibility

About

This study aims to compare antibiotic treatment versus surgery for patients with uncomplicated appendicitis.

Full description

The study will include patients aged 16 and over, with a first admission with right iliac fossa pain and a raised white cell count or C-reactive protein. Patients will be randomised electronically in a 1:1 ratio either to undergo emergency appendectomy or to receive intravenous antibiotics as an inpatient, until clinical and biochemical improvement is observed, followed by outpatient oral antibiotics. Those who have surgery will have 3 post-operative doses of intravenous antibiotics, unless perforation was identified at the time of surgery, in which case, microbiology will be contacted to advise regarding antibiotic choice and duration. Follow-up by telephone interview will be at 1 week, 1, 3 and 12-month intervals.

Enrollment: 186 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Right iliac fossa pain
• 1st episode in the past 1 year
• Raised WCC or CRP
• Fluent in English

Exclusion criteria

• History of inflammatory bowel disease or appendectomy
• B-HCG positive
• Significant co-morbidities
• Complicated appendicitis as proven by ultrasound, CT or MRI
• Anaphylaxis to penicillin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 2 patient groups

Operative Intervention

Active Comparator group

Description:

Laparoscopic +/- open appendicectomy, with antibiotics at induction and 3 further doses of intravenous antibiotics. Co-amoxiclav, or cefuroxime and metronidazole if previous rash-allergy to penicillin.

Treatment:

Procedure: Laparoscopic +/- Open Appendicectomy

Antibiotic Treatment

Experimental group

Description:

Intravenous antibiotics until clinical improvement and then 5 further days of oral antibiotics. Co-amoxiclav, or if rash-allergy to penicillin, cefuroxime and metronidazole.

Treatment:

Drug: Antibiotic treatment