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Tonsillectomy in Recurrent Tonsillitis

NCT ID: NCT00136877

Last Updated: 2006-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2005-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Tonsillitis

Keywords

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recurrent tonsillitis streptococcus tonsillectomy prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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(adeno)tonsillectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oulu University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Olli-Pekka Alho, MD

Role: STUDY_DIRECTOR

Dept of Otolaryngology, University of Oulu, Finland

Locations

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Oulu University Hospital

Oulu, , Finland

Site Status

Countries

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Finland

References

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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. doi: 10.1136/bmj.39140.632604.55. Epub 2007 Mar 8.

Reference Type DERIVED
PMID: 17347187 (View on PubMed)

Other Identifiers

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Diary nro 135/2001

Identifier Type: -

Identifier Source: org_study_id