TonsillitisPhase 4NCT00547391
Recurrent Throat Infections and Tonsillectomy
A Phase 4 study testing Tonsillectomy in people with Tonsillitis and Pharyngitis, run by Oulu University Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to find out if tonsillectomy reduces the short-term risk of having an objectively confirmed (sequential changes in serum crp and procalcitonin levels) delayed pharyngitis episode among patients suffering from recurrent pharyngitis episodes. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Tonsillitis, Pharyngitis
- What is being tested?
- Tonsillectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2007to Jun 2011
- Phase
- Phase 4
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients selected among the cases referred to tonsillectomy for recurrent pharyngitis episodes to a tertiary care university ENT clinic (Oulu, Finland).
- At least three pharyngitis episodes difficult enough for the patients to seek for medical attention during the past 12 months
Who cannot join
- Patients with other serious diseases (day surgery not feasible)
- Patients having long time antibiotic treatment for other disease
- Patients diagnosed to have peritonsillar abscess
- Pregnancy
- Age of 12 or under
- Patients living outside Oulu or its 8 neighbouring cities (day surgery not feasible)
- Patients suffering only from halitosis or bacterial plugs of palatine tonsils
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to find out if tonsillectomy reduces the short-term risk of having an objectively confirmed (sequential changes in serum crp and procalcitonin levels) delayed pharyngitis episode among patients suffering from recurrent pharyngitis episodes. Other aims are to find out the effect of tonsillectomy to reduce the number of pharyngitis episodes or symptoms. Still, the possible disadvantages of tonsillectomy and changes in the quality of life after tonsillectomy among these patients are examined.
Read the detailed description
We will have a prospective randomized study. We allocated 87 consecutive patients referred for tonsillectomy randomly in two groups: tonsilectomy group or waiting list(control group). Patients in tonsillectomy group were operated as soon as possible and data on postoperative morbidity was collected. In the control group, patients were placed on our normal waiting list and they were operated on in normal time (about 5-6 months). The data on preoperative morbidity was collected. All the pharyngitis episodes were treated by a study investigator and laboratory tests (crp, procalcitonin) were taken at that time and after three days. In addition, the patients record their symptoms on a diary.
- Conditions
- Tonsillitis, Pharyngitis
- Being tested
- Tonsillectomy, no intervention
- Keywords
- adults, children, tonsillectomy
- Medical subject headings
- Tonsillitis, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TonsillectomyProcedure or surgery
Tonsillectomy under general anesthesia as a day surgery using diathermy or blunt dissection. Follow up started from the day of surgery.
no interventionOther
No intervention (controls). Follow up started from the day of randomization.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | patients on waiting list for a minimum of 5 months. These patients receive no prophylactic intervention for their recurrent pharyngitis episodes. Receives: Other: no intervention |
| 2 | Active comparator | Tonsillectomy as soon as possible after randomization (within 2-3 weeks). Receives: Procedure: Tonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute percentage difference between groups of patients having pharyngitis with delayed recovery time defined by symptoms and blood sample values (crp, procalcitonin)
Measured: 5 months follow up
Secondary outcomes (4)
Absolute percentage difference of patients having group A streptococcal pharyngitis.
Measured: 5 months follow up
Absolute percentage difference of patients having acute pharyngitis episode with and without medical consultation
Measured: 5 months follow up
Difference in the number and quality (mild, severe) of symptomatic days (fever, sore throat, rhinitis, cough)
Measured: 5 months follow up
Absolute percentage difference having harmful effects related to tonsillectomy (haemorrhage, soft tissue burns etc.)
Measured: 5 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2010
- Study completionJun 2011
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petri Koivunen, MD, Principal investigator, Dept of Otolaryngology, University of Oulu, FinlandAila Kristo, MD, Principal investigator, Dept of Otolaryngology, University of Oulu, FinlandOnni Niemelä, Principal investigator, Laboratory, University of Oulu, FinlandMarkku Koskela, Principal investigator, Microbiological Laboratory, University of Oulu, FinlandTimo J Koskenkorva, MD, Principal investigator, Dept of Otolaryngology, University of Oulu, FinlandOlli-Pekka Alho, professor, Study chair, Dept of Otolaryngology, University of Oulu, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547391
- Sponsor's protocol ID
- Diary nr 106/2007
- Status last verified
- Feb 2012
- First submitted
- 19 Oct 2007
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Koskenkorva T, Koivunen P, Koskela M, Niemela O, Kristo A, Alho OP. Short-term outcomes of tonsillectomy in adult patients with recurrent pharyngitis: a randomized controlled trial. CMAJ. 2013 May 14;185(8):E331-6. doi: 10.1503/cmaj.121852. Epub 2013 Apr 2.
PubMed 23549975
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrent Throat Infections and Tonsillectomy
- ClinicalTrials.gov ID
- NCT00547391
- Acronym / sponsor ID
- Diary nr 106/2007
- Conditions
- Tonsillitis, Pharyngitis
- Keywords
- adults, children, tonsillectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 22 Oct 2007 (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 find out if tonsillectomy reduces the short-term risk of having an objectively confirmed (sequential changes in serum crp and procalcitonin levels) delayed pharyngitis episode among patients suffering from recurrent pharyngitis episodes. Other aims are to find out the effect of tonsillectomy to reduce the number of pharyngitis episodes or symptoms. Still, the possible disadvantages of tonsillectomy and changes in the quality of life after tonsillectomy among these patients are examined.
Detailed description
We will have a prospective randomized study. We allocated 87 consecutive patients referred for tonsillectomy randomly in two groups: tonsilectomy group or waiting list(control group). Patients in tonsillectomy group were operated as soon as possible and data on postoperative morbidity was collected. In the control group, patients were placed on our normal waiting list and they were operated on in normal time (about 5-6 months). The data on preoperative morbidity was collected. All the pharyngitis episodes were treated by a study investigator and laboratory tests (crp, procalcitonin) were taken at that time and after three days. In addition, the patients record their symptoms on a diary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | Other: no interventionpatients on waiting list for a minimum of 5 months. These patients receive no prophylactic intervention for their recurrent pharyngitis episodes. |
| 2 | Active comparator | Procedure: TonsillectomyTonsillectomy as soon as possible after randomization (within 2-3 weeks). |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients selected among the cases referred to tonsillectomy for recurrent pharyngitis episodes to a tertiary care university ENT clinic (Oulu, Finland).
- At least three pharyngitis episodes difficult enough for the patients to seek for medical attention during the past 12 months
Key exclusion criteria (7 listed)
- Patients with other serious diseases (day surgery not feasible)
- Patients having long time antibiotic treatment for other disease
- Patients diagnosed to have peritonsillar abscess
- Pregnancy
- Age of 12 or under
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 |
|---|---|---|
| TonsillectomyTonsillectomy under general anesthesia as a day surgery using diathermy or blunt dissection. Follow up started from the day of surgery. | Procedure or surgery | 2 |
| no interventionNo intervention (controls). Follow up started from the day of randomization. | Other | 1 |
Primary outcome
Absolute percentage difference between groups of patients having pharyngitis with delayed recovery time defined by symptoms and blood sample values (crp, procalcitonin)
Time frame: 5 months follow up
4 secondary outcomes
Absolute percentage difference of patients having group A streptococcal pharyngitis.
Time frame: 5 months follow up
Absolute percentage difference of patients having acute pharyngitis episode with and without medical consultation
Time frame: 5 months follow up
Difference in the number and quality (mild, severe) of symptomatic days (fever, sore throat, rhinitis, cough)
Time frame: 5 months follow up
Absolute percentage difference having harmful effects related to tonsillectomy (haemorrhage, soft tissue burns etc.)
Time frame: 5 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2012.
- Derived from this study: PubMed 23549975Koskenkorva T, Koivunen P, Koskela M, Niemela O, Kristo A, Alho OP. Short-term outcomes of tonsillectomy in adult patients with recurrent pharyngitis: a randomized controlled trial. CMAJ. 2013 May 14;185(8):E331-6. doi: 10.1503/cmaj.121852. Epub 2013 Apr 2.
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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.
Petri Koivunen, MD principal investigator
Dept of Otolaryngology, University of Oulu, Finland
Aila Kristo, MD principal investigator
Dept of Otolaryngology, University of Oulu, Finland
Onni Niemelä principal investigator
Laboratory, 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 Phase 4 study testing Tonsillectomy in people with Tonsillitis and Pharyngitis, 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 19 Apr 2012. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Absolute percentage difference between groups of patients having pharyngitis with delayed recovery time defined by symptoms and blood sample values (crp, procalcitonin) (time frame: 5 months follow up). 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 NCT00547391, 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 19 Apr 2012.