Tonsillectomy in Recurrent Tonsillitis - Full Text View

Sponsored by:	Oulu University Hospital
Information provided by:	Oulu University Hospital
ClinicalTrials.gov Identifier:	NCT00136877

Purpose

The purpose of this study is to determine whether tonsillectomy is effective in preventing further streptococcal pharyngitis episodes in patients with recurrent tonsillitis.

Condition	Intervention
Tonsillitis	Procedure: (adeno)tonsillectomy

MedlinePlus related topics: Sore Throat Tonsils and Adenoids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Tonsillectomy on Preventing Recurrent Streptococcal Throat Infections: A Randomized Controlled Trial

Further study details as provided by Oulu University Hospital:

Primary Outcome Measures:

microbiologically confirmed streptococcal pharyngitis episodes

Secondary Outcome Measures:

side effects
symptoms
quality of life issues

Estimated Enrollment:	70
Study Start Date:	October 2001
Estimated Study Completion Date:	December 2005

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.

Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136877

Locations

Finland
Oulu University Hospital
Oulu, Finland, FIN-90029

Sponsors and Collaborators

Oulu University Hospital

Investigators

Study Director:

Olli-Pekka Alho, MD

Dept of Otolaryngology, University of Oulu, Finland

More Information

Publications indexed to this study:

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.

Study ID Numbers:	Diary nro 135/2001
Study First Received:	August 26, 2005
Last Updated:	December 27, 2006
ClinicalTrials.gov Identifier:	NCT00136877
Health Authority:	Finland: National Agency for Medicines

Keywords provided by Oulu University Hospital:

recurrent tonsillitis
streptococcus
tonsillectomy
prevention

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Tonsillitis

Stomatognathic Diseases
Pharyngeal Diseases
Recurrence

ClinicalTrials.gov processed this record on January 16, 2009