TonsillitisNCT00136877
Tonsillectomy in Recurrent Tonsillitis
A study testing (adeno)tonsillectomy in people with Tonsillitis, run by Oulu University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Tonsillitis
- What is being tested?
- (adeno)tonsillectomy
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2001to Dec 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- At least 3 tonsillitis episodes during the preceding year (at least one verified by culture or antigen testing)
Who cannot join
- Other serious illness
- Long term antibiotic treatment for other disease
- Documented immunologic disorder
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Tonsillectomy on Preventing Recurrent Streptococcal Throat Infections: A Randomized Controlled Trial
The purpose of this study is to determine whether tonsillectomy is effective in preventing further streptococcal pharyngitis episodes in patients with recurrent tonsillitis.
Read the 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.
- Conditions
- Tonsillitis
- Being tested
- (adeno)tonsillectomy
- Keywords
- recurrent tonsillitis, streptococcus, tonsillectomy, prevention
- Medical subject headings
- Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(adeno)tonsillectomyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
microbiologically confirmed streptococcal pharyngitis episodes
Secondary outcomes (3)
side effects
symptoms
quality of life issues
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startOct 2001
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TonsillitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Olli-Pekka Alho, MD, Study director, Dept of Otolaryngology, University of Oulu, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136877
- Sponsor's protocol ID
- Diary nro 135/2001
- Status last verified
- Dec 2006
- First submitted
- 26 Aug 2005
- Last updated
- 29 Dec 2006
- Results posted
- No
Publications
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.
PubMed 17347187
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tonsillectomy on Preventing Recurrent Streptococcal Throat Infections: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00136877
- Acronym / sponsor ID
- Diary nro 135/2001
- Conditions
- Tonsillitis
- Keywords
- recurrent tonsillitis, streptococcus, tonsillectomy, prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Study start
- Oct 2001
- Study completion
- Dec 2005
- First posted
- 29 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- At least 3 tonsillitis episodes during the preceding year (at least one verified by culture or antigen testing)
Key exclusion criteria (4 listed)
- Other serious illness
- Long term antibiotic treatment for other disease
- Documented immunologic disorder
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (adeno)tonsillectomy | Procedure or surgery | – |
Primary outcome
microbiologically confirmed streptococcal pharyngitis episodes
3 secondary outcomes
side effects
symptoms
quality of life issues
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2006.
- Derived from this study: PubMed 17347187Alho 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olli-Pekka Alho, MD study director
Dept of Otolaryngology, University of Oulu, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (adeno)tonsillectomy in people with Tonsillitis, run by Oulu University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microbiologically confirmed streptococcal pharyngitis episodes. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00136877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2006.