Tonsillectomy in Recurrent Tonsillitis | NCT00136877

Studies
Tonsillectomy in Recurrent Tonsillitis

NCT00136877

Sponsor

Oulu University Hospital

Status

Unknown status

Last Update Posted

Dec 29, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Tonsillitis

Interventions

(adeno)tonsillectomy

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2001

Primary Completion Date

Not provided

Completion Date

Dec 2005

First Submitted Date

Aug 26, 2005

First Submission Date that Met QC Criteria

Aug 26, 2005

First Posted Date

Aug 29, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 27, 2006

Last Update Posted Date

Dec 29, 2006Estimated

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
(adeno)tonsillectomy	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
microbiologically confirmed streptococcal pharyngitis episodes

Secondary Outcomes

Measure	Description	Time Frame
side effects
symptoms
quality of life issues

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olli-Pekka Alho, MD	Dept of Otolaryngology, University of Oulu, Finland	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oulu University Hospital		Oulu		FIN-90029	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17347187	Derived	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.

ID	Term
D010612	Pharyngitis
D012141	Respiratory Tract Infections
D007239	Infections
D010608	Pharyngeal Diseases