Study of Conservative Versus Surgical Treatment of Appendicitis
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|ClinicalTrials.gov Identifier: NCT00469430|
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : April 21, 2009
|Condition or disease||Intervention/treatment||Phase|
|Appendicitis||Drug: cefotaxim and metronidazol||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Study of Conservative Versus Surgical Treatment of Appendicitis; Analyses of Result and Economics|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||October 2008|
No Intervention: Op
Drug: cefotaxim and metronidazol
iv administration for at least 24 h
- treatment efficacy [ Time Frame: one year ]
- complications [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00469430
|Göteborg University, Sahlgrenska Universitetssjukhuset|
|Principal Investigator:||Kent Lundholm||Göteborg University|