Clinical trial NCT00469430: Study of Conservative Versus Surgical Treatment of Appendicitis
Official title: Randomized Study of Conservative Versus Surgical Treatment of Appendicitis; Analyses of Result and Economics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Appendicitis
Keywords: appendicitis
treatment
antibiotics
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2007-05-04
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* Suspected appendicitis in patients over 18 years

Exclusion Criteria:

* Under 18 years

Primary outcomes:
measure: treatment efficacy
timeFrame: one year
Secondary outcomes:
measure: complications
timeFrame: one year
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Göteborg University, Sahlgrenska Universitetssjukhuset
Study officials:
affiliation: Göteborg University
name: Kent Lundholm
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eriksson S, Granstrom L. Randomized controlled trial of appendicectomy versus antibiotic therapy for acute appendicitis. Br J Surg. 1995 Feb;82(2):166-9. doi: 10.1002/bjs.1800820207.
citation: 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. doi: 10.1007/s00268-005-0304-6.
citation: Hansson J, Korner U, Khorram-Manesh A, Solberg A, Lundholm K. Randomized clinical trial of antibiotic therapy versus appendicectomy as primary treatment of acute appendicitis in unselected patients. Br J Surg. 2009 May;96(5):473-81. doi: 10.1002/bjs.6482.