Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis

Official Title: “Study of Surgical Treatment (Open Appendicectomy) Versus Antibiotic Treatment (Ertapenem) in the Treatment of Acute Uncomplicated Appendicitis”

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.

Intervention(s) in this Clinical Trial

• Procedure: Appendicectomy
  • Standard appendicectomy
• Drug: Ertapenem
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Operative treatment
  • Regular open appendicectomy
• Active Comparator: Antibiotic treatment
  • Ertapenem 1 g i.v. x 1 three days

Primary Measures

• The success of antibiotic and surgical treatment in the treatment of acute uncomplicated appendicitis
  • Time Frame: 1.-3. days, 1 week, 2 months, 1 year, 3,5,10 y
    Safety Issue?: No

Secondary Measures

• The possible complications, morbidity and mortality of operative and conservative treatment
  • Time Frame: Same as primary outcome measure
    Safety Issue?: No
• The direct and indirect costs of both treatment arms
  • Time Frame: Same as primary outcome measure
    Safety Issue?: No
• The recurrence of conservatively treated appendicitis
  • Time Frame: Same as primary outcome measure
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Turku University Hospital Other

Overall Clinical Trial Officials and Contacts

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

Overall Contact: Paulina Salminen, MD, PhD +358 2 313 0542 paulina.salminen@tyks.fi

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01022567

Study ID Number: APPAC

ClinicalTrials.gov Identifier: NCT01022567

Health Authority: Finland: Ethics Committee