Study of Conservative Versus Surgical Treatment of Appendicitis

Appendicitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00469430
• Other study ID #: 1-Hansson
• Status: Completed
• Phase: Phase 2
• First received: May 3, 2007
• Last updated: April 20, 2009
• Start date: May 2006
• Est. completion date: October 2008

Study information

• Verified date: April 2009
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: October 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Suspected appendicitis in patients over 18 years

Exclusion Criteria:

• Under 18 years

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendicitis

Intervention

Drug:
• cefotaxim and metronidazol
iv administration for at least 24 h

Locations

Country	Name	City	State
Sweden	Göteborg University, Sahlgrenska Universitetssjukhuset	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Eriksson S, Granström L. Randomized controlled trial of appendicectomy versus antibiotic therapy for acute appendicitis. Br J Surg. 1995 Feb;82(2):166-9. — View Citation

Styrud J, Eriksson S, Nilsson I, Ahlberg G, Haapaniemi S, Neovius G, Rex L, Badume I, Granström L. Appendectomy versus antibiotic treatment in acute appendicitis. a prospective multicenter randomized controlled trial. World J Surg. 2006 Jun;30(6):1033-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment efficacy		one year	No
Secondary	complications		one year	Yes