Study of Conservative Versus Surgical Treatment of Appendicitis

NCT ID: NCT00469430

Last Updated: 2009-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2008-10-31

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

Conditions

Appendicitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Op

traditional surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Ab

antibiotic treatment

Group Type: EXPERIMENTAL

cefotaxim and metronidazol

Intervention Type: DRUG

iv administration for at least 24 h

Interventions

cefotaxim and metronidazol

iv administration for at least 24 h

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Suspected appendicitis in patients over 18 years

Exclusion Criteria

• Under 18 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Göteborg University

Principal Investigators

Kent Lundholm

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

Göteborg University, Sahlgrenska Universitetssjukhuset

Gothenburg, Göteborg, Sweden

Countries

Sweden

References

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.

Reference Type: BACKGROUND

PMID: 7749676 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16736333 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19358184 (View on PubMed)

Other Identifiers

1-Hansson

Identifier Type: -

Identifier Source: org_study_id