Study of Conservative Versus Surgical Treatment of Appendicitis

This study has been completed.
Sponsor:
Information provided by:
Göteborg University
ClinicalTrials.gov Identifier:
NCT00469430
First received: May 3, 2007
Last updated: April 20, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Appendicitis
Drug: cefotaxim and metronidazol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Study of Conservative Versus Surgical Treatment of Appendicitis; Analyses of Result and Economics

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • treatment efficacy [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complications [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 360
Study Start Date: May 2006
Study Completion Date: October 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Op
traditional surgery
Experimental: Ab
antibiotic treatment
Drug: cefotaxim and metronidazol
iv administration for at least 24 h

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Suspected appendicitis in patients over 18 years

Exclusion Criteria:

  • Under 18 years
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00469430

Locations
Sweden
Göteborg University, Sahlgrenska Universitetssjukhuset
Göteborg, Sweden
Sponsors and Collaborators
Göteborg University
Investigators
Principal Investigator: Kent Lundholm Göteborg University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeanette Hansson, Göteborg University
ClinicalTrials.gov Identifier: NCT00469430     History of Changes
Other Study ID Numbers: 1-Hansson
Study First Received: May 3, 2007
Last Updated: April 20, 2009
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Göteborg University:
appendicitis
treatment
antibiotics

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Cefotaxime
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014