Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis (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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study of Surgical Treatment (Open Appendicectomy) Versus Antibiotic Treatment (Ertapenem) in the Treatment of Acute Uncomplicated Appendicitis|
- 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 ] [ Designated as safety issue: No ]A successful treatment is determined by resolution of the appendicitis by means of the assigned treatment.
- The possible complications, morbidity and mortality of operative and conservative treatment [ Time Frame: Same as primary outcome measure ] [ Designated as safety issue: No ]
- The direct and indirect costs of both treatment arms [ Time Frame: Same as primary outcome measure ] [ Designated as safety issue: No ]
- The recurrence of conservatively treated appendicitis [ Time Frame: Same as primary outcome measure ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||December 2025|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Operative treatment
Regular open appendicectomy
Active Comparator: Antibiotic treatment
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01022567
|Keski-Suomi Central Hosptal|
|Mikkeli Central Hospital|
|Oulu University Hospital|
|Seinäjoki Central Hospital|
|Tampere University Hospital|
|Turku University Hospital|
|Principal Investigator:||Paulina Salminen, MD, PhD||Department of surgery, Turku University Hospital|