CI

At a glance

ClinicalIndex Comparison Record
N/AUnknown· 530 enrolled
Drug / intervention
Ertapenem +1 moredrug
Likely dose
Ertapenem 1gfrom record
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Search/NCT01022567
NCT01022567N/AUnknown

Study of Surgical Treatment (Open Appendicectomy) Versus Antibiotic Treatment (Ertapenem) in the Treatment of Acute Uncomplicated Appendicitis

Turku University Hospital·interventional·Posted Dec 1, 2009·Updated Jun 28, 2018

In Brief

A clinical study evaluating Appendicectomy and Ertapenem for Acute Appendicitis. Targeting 530 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFinland

Timeline

N/AUnknownOverdue
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 1, 2009
Enrollment StartNov 1, 2009
Primary CompletionJun 1, 2012
Study CompletionDec 1, 2025
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 16.6 years ago

Interventions

Appendicectomyprocedure

Standard appendicectomy

Ertapenemdrug

ertapenem 1g x 1 i.v.for three days + after discharge levofloxacin 500 mg 1 x 1 + metronidazole 500 mg 1x3 for 7 days p.o.