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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00136877
Other study ID # Diary nro 135/2001
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 26, 2005
Last updated December 27, 2006
Start date October 2001
Est. completion date December 2005

Study information

Verified date December 2006
Source Oulu University Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Finnish Medicines Agency
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 70
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 14 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
(adeno)tonsillectomy


Locations

Country Name City State
Finland Oulu University Hospital Oulu

Sponsors (1)

Lead Sponsor Collaborator
Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary microbiologically confirmed streptococcal pharyngitis episodes
Secondary side effects
Secondary symptoms
Secondary quality of life issues
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