Study of Conservative Versus Surgical Treatment of Appendicitis
The purpose of this study is to determine if antibiotic treatment of appendicitis is an option compared to surgery. The investigators' hypothesis is that a majority of patients with appendicitis can heal without surgery and that there are several advantages with antibiotic treatment related to time to recover, complications and economical aspects.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Study of Conservative Versus Surgical Treatment of Appendicitis; Analyses of Result and Economics|
- treatment efficacy [ Time Frame: one year ] [ Designated as safety issue: No ]
- complications [ Time Frame: one year ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2006|
|Study Completion Date:||October 2008|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
No Intervention: Op
Drug: cefotaxim and metronidazol
iv administration for at least 24 h
Appendicitis is a common disease; 1/1000 gets it every year. 7% will get appendicitis during their lifetime. Surgery, open or laparoscopic, is the traditional treatment. A number of these patients don´t have appendicitis when operated on and the operation is therefore unnecessarily performed. It is also a risk for complications after surgery; for instance wound infection, postoperative small bowel obstruction.
In our study we will compare antibiotic as the only treatment with traditional surgical treatment. Patients with "suspected appendicitis" are randomized to either surgery or antibiotics according to their birth date.
Patients in "the surgery group" are treated according to standard routines. Patients in "the antibiotic group" are treated with intravenous antibiotics for at least 24h - this regime can be prolonged if clinical recovery doesn´t occur - and submitted from hospital with oral antibiotics. If patients in the antibiotic group deteriorate during the hospital stay (suspicious perforation) they will be operated.
Parameters that will be analyzed are:
- primary healing in the antibiotic group
- frequency of relapse in appendicitis in the antibiotic group
- complications in both groups
- economical analysis (hospital stay, sick leave time, time off work) in both groups
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469430
|Göteborg University, Sahlgrenska Universitetssjukhuset|
|Principal Investigator:||Kent Lundholm||Göteborg University|