Tonsillectomy in Recurrent Tonsillitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Oulu University Hospital

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
Tonsillitis Procedure: (adeno)tonsillectomy

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 : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. microbiologically confirmed streptococcal pharyngitis episodes

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00136877

Oulu University Hospital
Oulu, Finland, FIN-90029
Sponsors and Collaborators
Oulu University Hospital
Study Director: Olli-Pekka Alho, MD Dept of Otolaryngology, University of Oulu, Finland

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00136877     History of Changes
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

Additional relevant MeSH terms:
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases