Back to resultsTonsillectomy in Recurrent Tonsillitis
Primary Purpose
Tonsillitis
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
(adeno)tonsillectomy
Sponsored by
About this trial
This is an interventional treatment trial for Tonsillitis focused on measuring recurrent tonsillitis, streptococcus, tonsillectomy, prevention
Eligibility Criteria
Inclusion Criteria: At least 3 tonsillitis episodes during the preceding year (at least one verified by culture or antigen testing) Exclusion Criteria: Other serious illness Long term antibiotic treatment for other disease Documented immunologic disorder Pregnancy
Sites / Locations
- Oulu University Hospital
Outcomes
Primary Outcome Measures
microbiologically confirmed streptococcal pharyngitis episodes
Secondary Outcome Measures
side effects
symptoms
quality of life issues
Full Information
NCT ID
NCT00136877
First Posted
August 26, 2005
Last Updated
December 27, 2006
Sponsor
Oulu University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00136877
Brief Title
Tonsillectomy in Recurrent Tonsillitis
Official Title
Effect of Tonsillectomy on Preventing Recurrent Streptococcal Throat Infections: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Oulu University Hospital
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether tonsillectomy is effective in preventing further streptococcal pharyngitis episodes in patients with recurrent tonsillitis.
Detailed Description
Tonsillectomy is widely used worldwide in recurrent streptococcal tonsillitis, but its effect remains unknown.
In this randomized controlled trial, the effect of tonsillectomy (compared to watchful waiting) in preventing further culture proven symptomatic streptococcal pharyngitis episodes is studied. In addition, symptoms after the operation, side effects, and life quality issues are recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillitis
Keywords
recurrent tonsillitis, streptococcus, tonsillectomy, prevention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
(adeno)tonsillectomy
Primary Outcome Measure Information:
Title
microbiologically confirmed streptococcal pharyngitis episodes
Secondary Outcome Measure Information:
Title
side effects
Title
symptoms
Title
quality of life issues
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 3 tonsillitis episodes during the preceding year (at least one verified by culture or antigen testing)
Exclusion Criteria:
Other serious illness
Long term antibiotic treatment for other disease
Documented immunologic disorder
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olli-Pekka Alho, MD
Organizational Affiliation
Dept of Otolaryngology, University of Oulu, Finland
Official's Role
Study Director
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
FIN-90029
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
17347187
Citation
Alho OP, Koivunen P, Penna T, Teppo H, Koskela M, Luotonen J. Tonsillectomy versus watchful waiting in recurrent streptococcal pharyngitis in adults: randomised controlled trial. BMJ. 2007 May 5;334(7600):939. doi: 10.1136/bmj.39140.632604.55. Epub 2007 Mar 8.
Results Reference
derived
Learn more about this trial
Tonsillectomy in Recurrent Tonsillitis
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