Study of Conservative Versus Surgical Treatment of Appendicitis

Phase 2

Completed

• Conditions: Appendicitis
• Interventions: Drug: cefotaxim and metronidazol

• Registration Number: NCT00469430
• Lead Sponsor: Göteborg University

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

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2007-05-03
• Study First Submitted QC: 2007-05-03
• Study First Posted: 2007-05-04
• Primary Completion: 2007-09
• Study Completion: 2008-10
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-20
• Last Update Posted: 2009-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Suspected appendicitis in patients over 18 years

Exclusion Criteria

• Under 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ab	cefotaxim and metronidazol	antibiotic treatment

Primary Outcome Measures

Name	Time	Method
treatment efficacy	one year

Secondary Outcome Measures

Name	Time	Method
complications	one year

Trial Locations

Locations (1)

Göteborg University, Sahlgrenska Universitetssjukhuset; 🇸🇪 Göteborg, Sweden