drugset / Trial / NCT01022567

Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis

NCT01022567

RandomizedParallel-groupOpen-labelTreatment

Summary

Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a "routine" operation. At the same time other similar intra-abdominal infections, such as diverticulitis, are treated with antibiotics. There have been some encouraging reports on successful treatment of appendicitis with antibiotics and it has been estimated that operative treatment might be necessary for only 15 - 20 % of patients with acute appendicitis. The aim of this randomized prospective study is to compare operative treatment (open appendicectomy) with conservative treatment with antibiotics (ertapenem, Invanz). Before randomization acute uncomplicated appendicitis is diagnosed with a CT scan.The hypothesis of the study is that the majority of patients with uncomplicated acute appendicitis can be treated successfully with antibiotics and unnecessary appendicectomies can be avoided.

Timeline

Start
2009-11
Primary completion
2012-06
Completion
2025-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ertapenem Small molecule 1 g Intravenous
Subject Levofloxacin Small molecule 500 mg Oral
Subject Metronidazole Small molecule 500 mg Oral

Indications