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

This study is currently Recruiting

May 2011 By Turku University Hospital

First Recieved on November 30, 2009

Last Updated on May 16, 2011

Sponsor: Turku University Hospital
Collaborators:
Information provided by: Turku University Hospital
Identifier: NCT01022567

Purpose

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 Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:Accepts Healthy Volunteers
Criteria

Inclusion Criteria: - Age range from 18 to 60 years - CT scan diagnosed uncomplicated acute appendicitis Exclusion Criteria: - Age under 18 years or age over 60 years - Pregnancy or breast-feeding - Allergy to contrast media or iodine - Renal insufficiency - metformin medication (DM) - Peritonitis (a perforated appendix) - Lack of co-operation (unable to give consent) - A severe other medical condition - CT-scan: other diagnosis, fecal lithiasis in appendix, perforation, abscess, suspicion of a tumour

Investigators

  • Investigator: Paulina Salminen, MD, PhD - Principal Investigator - Department of surgery, Turku University Hospital

Locations

  • Pohjois-Karjala Central Hospital

    Joensuu, Finland

  • Keski-Suomi Central Hosptal

    Jyv?skyl?, Finland

  • Mikkeli Central Hospital

    Mikkeli, Finland

  • Oulu University Hospital

    Oulu, Finland

  • Sein?joki Central Hospital

    Sein?joki, Finland

  • Tampere University Hospital

    Tampere, Finland

  • Turku University Hospital

    Turku, Finland

Conditions related to this trial:

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