Tonsillectomy in Recurrent Tonsillitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Oulu University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Oulu University Hospital
ClinicalTrials.gov Identifier:
NCT00136877
First received: August 26, 2005
Last updated: December 27, 2006
Last verified: December 2006
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Tonsillectomy on Preventing Recurrent Streptococcal Throat Infections: A Randomized Controlled Trial

Resource links provided by NLM:


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
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, see Learn About Clinical Studies.

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

No publications provided by Oulu University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00136877     History of Changes
Other Study ID Numbers: Diary nro 135/2001
Study First Received: August 26, 2005
Last Updated: December 27, 2006
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Oulu University Hospital:
recurrent tonsillitis
streptococcus
tonsillectomy
prevention

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

ClinicalTrials.gov processed this record on July 26, 2014