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Study of Conservative Versus Surgical Treatment of Appendicitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00469430
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : April 21, 2009
Information provided by:
Göteborg University

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.

Condition or disease Intervention/treatment Phase
Appendicitis Drug: cefotaxim and metronidazol Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Study of Conservative Versus Surgical Treatment of Appendicitis; Analyses of Result and Economics
Study Start Date : May 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Arm Intervention/treatment
No Intervention: Op
traditional surgery
Experimental: Ab
antibiotic treatment
Drug: cefotaxim and metronidazol
iv administration for at least 24 h

Primary Outcome Measures :
  1. treatment efficacy [ Time Frame: one year ]

Secondary Outcome Measures :
  1. complications [ Time Frame: one year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Suspected appendicitis in patients over 18 years

Exclusion Criteria:

  • Under 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00469430

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Göteborg University, Sahlgrenska Universitetssjukhuset
Göteborg, Sweden
Sponsors and Collaborators
Göteborg University
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Principal Investigator: Kent Lundholm Göteborg University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jeanette Hansson, Göteborg University Identifier: NCT00469430    
Other Study ID Numbers: 1-Hansson
First Posted: May 4, 2007    Key Record Dates
Last Update Posted: April 21, 2009
Last Verified: April 2009
Keywords provided by Göteborg University:
Additional relevant MeSH terms:
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Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents