Study of Conservative Versus Surgical Treatment of Appendicitis
Primary Purpose
Appendicitis
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
cefotaxim and metronidazol
Sponsored by
About this trial
This is an interventional treatment trial for Appendicitis focused on measuring appendicitis, treatment, antibiotics
Eligibility Criteria
Inclusion Criteria:
- Suspected appendicitis in patients over 18 years
Exclusion Criteria:
- Under 18 years
Sites / Locations
- Göteborg University, Sahlgrenska Universitetssjukhuset
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Op
Ab
Arm Description
traditional surgery
antibiotic treatment
Outcomes
Primary Outcome Measures
treatment efficacy
Secondary Outcome Measures
complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00469430
Brief Title
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
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Göteborg University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
Keywords
appendicitis, treatment, antibiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Op
Arm Type
No Intervention
Arm Description
traditional surgery
Arm Title
Ab
Arm Type
Experimental
Arm Description
antibiotic treatment
Intervention Type
Drug
Intervention Name(s)
cefotaxim and metronidazol
Intervention Description
iv administration for at least 24 h
Primary Outcome Measure Information:
Title
treatment efficacy
Time Frame
one year
Secondary Outcome Measure Information:
Title
complications
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suspected appendicitis in patients over 18 years
Exclusion Criteria:
Under 18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kent Lundholm
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Göteborg University, Sahlgrenska Universitetssjukhuset
City
Göteborg
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
7749676
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.
Results Reference
background
PubMed Identifier
16736333
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.
Results Reference
background
PubMed Identifier
19358184
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. Erratum In: Br J Surg. 2009 Jul;96(7):830.
Results Reference
derived
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Study of Conservative Versus Surgical Treatment of Appendicitis
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