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Study of Conservative Versus Surgical Treatment of Appendicitis

Randomized Study of Conservative Versus Surgical Treatment of Appendicitis; Analyses of Result and Economics

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00469430
Enrollment
360
Registered
2007-05-04
Start date
2006-05-31
Completion date
2008-10-31
Last updated
2009-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis

Keywords

appendicitis, treatment, antibiotics

Brief summary

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.

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

Interventions

DRUGcefotaxim and metronidazol

iv administration for at least 24 h

Sponsors

Göteborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Suspected appendicitis in patients over 18 years

Exclusion criteria

* Under 18 years

Design outcomes

Primary

MeasureTime frame
treatment efficacyone year

Secondary

MeasureTime frame
complicationsone year

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026