Tonsillectomy in Recurrent Tonsillitis

• Sponsor: Oulu University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00136877
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Duration (Months): 50
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• 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: Oct 1, 2001
• Study Completion Date: Dec 1, 2005

Outcome Measures

Primary Outcome Measures

1. microbiologically confirmed streptococcal pharyngitis episodes []

Secondary Outcome Measures

1. side effects []

2. symptoms []

3. quality of life issues []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00136877
• Other Study ID Numbers: Diary nro 135/2001
• First Posted: Aug 29, 2005
• Last Update Posted: Dec 29, 2006
• Last Verified: Dec 1, 2006

• Keywords provided by , ,: recurrent tonsillitis; streptococcus; tonsillectomy; prevention
• Additional relevant MeSH terms: Tonsillitis

Study Results

No Results Posted as of Dec 29, 2006