Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00469430
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : April 21, 2009
Sponsor:
Information provided by:
Göteborg University

Tracking Information
First Submitted Date  ICMJE May 3, 2007
First Posted Date  ICMJE May 4, 2007
Last Update Posted Date April 21, 2009
Study Start Date  ICMJE May 2006
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2008)
treatment efficacy [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2007)
  • primary healing [ Time Frame: 30 days ]
  • recidiv [ Time Frame: 1 year ]
  • complications [ Time Frame: 30 days ]
Change History Complete list of historical versions of study NCT00469430 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2008)
complications [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2007)
costbenefitanalyses [ Time Frame: 30 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Conservative Versus Surgical Treatment of Appendicitis
Official Title  ICMJE Randomized Study of Conservative Versus Surgical Treatment of Appendicitis; Analyses of Result and Economics
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Appendicitis
Intervention  ICMJE Drug: cefotaxim and metronidazol
iv administration for at least 24 h
Study Arms  ICMJE
  • No Intervention: Op
    traditional surgery
  • Experimental: Ab
    antibiotic treatment
    Intervention: Drug: cefotaxim and metronidazol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2008)
360
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2007)
300
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Suspected appendicitis in patients over 18 years

Exclusion Criteria:

  • Under 18 years
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00469430
Other Study ID Numbers  ICMJE 1-Hansson
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeanette Hansson, Göteborg University
Study Sponsor  ICMJE Göteborg University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kent Lundholm Göteborg University
PRS Account Göteborg University
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP