Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis

Beaumont Hospital186 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

186

Conditions

Appendicitis

Interventions

Laparoscopic +/- Open AppendicectomyPROCEDURE

Laparoscopic +/- open appendicectomy , with antibiotics at induction (intravenous co-amoxiclav 1.2g, or if penicillin allergic, cefuroxime 1.5g + metronidazole 500mg ), followed by 3 further intravenous doses of the same antibiotic. If a perforation is identified at the time of surgery, microbiology will be contacted regarding choice and duration of of antibiotic.

Antibiotic treatmentDRUG

Intravenous co-amoxiclav 1.2g three times daily, then 625mg, orally three times daily. If penicillin allergic, intravenous cefuroxime 1.5g three times daily + metronidazole 500mg three times daily, then oral cefuroxime 500mg twice daily + oral metronidazole 400mg three times daily. The patient will receive inpatient intravenous antibiotics until sufficient clinical improvement is noted by the surgical team, who will be assessing the patient twice daily. After discharge the patient will receive 5 further days of oral antibiotics.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Beaumont Hospital

Dublin, Ireland

Outcomes

Primary Outcomes

Successful treatment of appendicitis

Successful treatment is defined as the resolution of appendicitis resulting in discharge from the hospital and no recurrent appendicitis during the one-year follow-up. The number of patients requiring surgery for appendicitis in the non-operative group will be measured.