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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

Tracking Information
First Submitted Date  ICMJE August 26, 2005
First Posted Date  ICMJE August 29, 2005
Last Update Posted Date December 29, 2006
Study Start Date  ICMJE October 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2005)
microbiologically confirmed streptococcal pharyngitis episodes
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2005)
  • side effects
  • symptoms
  • quality of life issues
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tonsillectomy in Recurrent Tonsillitis
Official Title  ICMJE Effect of Tonsillectomy on Preventing Recurrent Streptococcal Throat Infections: A Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tonsillitis
Intervention  ICMJE Procedure: (adeno)tonsillectomy
Study Arms  ICMJE Not Provided
Publications * 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. Epub 2007 Mar 8.

*   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 Unknown status
Enrollment  ICMJE
 (submitted: August 26, 2005)
70
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years and older   (Child, 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 Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00136877
Other Study ID Numbers  ICMJE Diary nro 135/2001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Oulu University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Olli-Pekka Alho, MD Dept of Otolaryngology, University of Oulu, Finland
PRS Account Oulu University Hospital
Verification Date December 2006

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