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Tonsillectomy in Recurrent Tonsillitis

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ClinicalTrials.gov Identifier: NCT00136877
Recruitment Status : Unknown
Verified December 2006 by Oulu University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 29, 2005
Last Update Posted : December 29, 2006
Sponsor:
Information provided by:
Oulu University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tonsillitis Procedure: (adeno)tonsillectomy Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Tonsillectomy on Preventing Recurrent Streptococcal Throat Infections: A Randomized Controlled Trial
Study Start Date : October 2001
Study Completion Date : December 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. microbiologically confirmed streptococcal pharyngitis episodes

Secondary Outcome Measures :
  1. side effects
  2. symptoms
  3. quality of life issues

Eligibility Criteria
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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00136877


Locations
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Finland
Oulu University Hospital
Oulu, Finland, FIN-90029
Sponsors and Collaborators
Oulu University Hospital
Investigators
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Study Director: Olli-Pekka Alho, MD Dept of Otolaryngology, University of Oulu, Finland
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00136877    
Other Study ID Numbers: Diary nro 135/2001
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: December 29, 2006
Last Verified: December 2006
Keywords provided by Oulu University Hospital:
recurrent tonsillitis
streptococcus
tonsillectomy
prevention
Additional relevant MeSH terms:
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Tonsillitis
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
 Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases