Viewing Study NCT01022567


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Study NCT ID: NCT01022567
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2018-06-28
First Post: 2009-11-30
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis
Sponsor: Turku University Hospital
Organization:

Study Overview

Official Title: Study of Surgical Treatment (Open Appendicectomy) Versus Antibiotic Treatment (Ertapenem) in the Treatment of Acute Uncomplicated Appendicitis
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2018-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: APPAC
Brief 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.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: