Study of Conservative Versus Surgical Treatment of Appendicitis

Condition(s) targeted: Appendicitis

Intervention: cefotaxim and metronidazol (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Göteborg University

Official(s) and/or principal investigator(s):
Kent Lundholm, ?, Principal Investigator, Affiliation: Göteborg University

The purpose of this study is to determine if antibiotic treatment of appendicitis is an option compared to surgery. Our 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.

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: treatment efficacy

Secondary outcome: complications

Detailed description: Appendicitis is a common disease; 1/1000 gets it every year. 7% will get appendicitis during lifetime. Surgery, open or laparoscopic, is the traditional treatment. A number of these patients doesn´t have appendicitis when operated on and the operation is therefore unnecessecaraly 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 birthdate.

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 analyzis (hospitalstay, sickleavetime, time off work) in both groups

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Suspected appendicitis in patients over 18 years

Exclusion Criteria:

- Under 18 years

Göteborg University, Sahlgrenska Universitetssjukhuset, Göteborg, Sweden

Related publications:

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

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

Starting date: May 2006
Ending date: September 2008
Last updated: May 6, 2008