Study of Conservative Versus Surgical Treatment of Appendicitis
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Appendicitis |
Drug: cefotaxim and metronidazol |
Phase 2 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 360 |
| Study Start Date: | May 2006 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Op
traditional surgery
|
|
|
Experimental: Ab
antibiotic treatment
|
Drug: cefotaxim and metronidazol
iv administration for at least 24 h
|
Detailed Description:
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Suspected appendicitis in patients over 18 years
Exclusion Criteria:
- Under 18 years
Contacts and Locations More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jeanette Hansson, Göteborg University |
| ClinicalTrials.gov Identifier: | NCT00469430 History of Changes |
| Other Study ID Numbers: | 1-Hansson |
| Study First Received: | May 3, 2007 |
| Last Updated: | April 20, 2009 |
| Health Authority: | Sweden: The National Board of Health and Welfare |
Keywords provided by Göteborg University:
|
appendicitis treatment antibiotics |
Additional relevant MeSH terms:
|
Appendicitis Acute Disease Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Cecal Diseases Intestinal Diseases |
Disease Attributes Pathologic Processes Anti-Bacterial Agents Cefotaxime Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013