This trial is active, not recruiting.

Condition acute appendicitis
Treatments appendicectomy, ertapenem
Sponsor Turku University Hospital
Collaborator Oulu University Hospital
Start date November 2009
End date June 2012
Trial size 530 participants
Trial identifier NCT01022567, APPAC


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Regular open appendicectomy
Standard appendicectomy
(Active Comparator)
Ertapenem 1 g i.v. x 1 three days
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.

Primary Outcomes

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

Secondary Outcomes

The possible complications, morbidity and mortality of operative and conservative treatment
time frame: Same as primary outcome measure
The direct and indirect costs of both treatment arms
time frame: Same as primary outcome measure
The recurrence of conservatively treated appendicitis
time frame: Same as primary outcome measure

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Study of Surgical Treatment (Open Appendicectomy) Versus Antibiotic Treatment (Ertapenem) in the Treatment of Acute Uncomplicated Appendicitis
Principal investigator Paulina Salminen, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Turku University Hospital.