Recurrent Throat Infections and Tonsillectomy
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ClinicalTrials.gov Identifier: NCT00547391 |
Recruitment Status :
Completed
First Posted : October 22, 2007
Last Update Posted : April 19, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tonsillitis Pharyngitis | Procedure: Tonsillectomy Other: no intervention | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 87 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Recurrent Throat Infections and Tonsillectomy |
Study Start Date : | November 2007 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | June 2011 |

Arm | Intervention/treatment |
---|---|
No Intervention: 1
patients on waiting list for a minimum of 5 months. These patients receive no prophylactic intervention for their recurrent pharyngitis episodes.
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Other: no intervention
No intervention (controls). Follow up started from the day of randomization. |
Active Comparator: 2
Tonsillectomy as soon as possible after randomization (within 2-3 weeks).
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Procedure: Tonsillectomy
Tonsillectomy under general anesthesia as a day surgery using diathermy or blunt dissection. Follow up started from the day of surgery. |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 13 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547391
Finland | |
Oulu University Hospital | |
Oulu, Finland |
Principal Investigator: | Petri Koivunen, MD | Dept of Otolaryngology, University of Oulu, Finland | |
Principal Investigator: | Aila Kristo, MD | Dept of Otolaryngology, University of Oulu, Finland | |
Principal Investigator: | Onni Niemelä | Laboratory, University of Oulu, Finland | |
Principal Investigator: | Markku Koskela | Microbiological Laboratory, University of Oulu, Finland | |
Principal Investigator: | Timo J Koskenkorva, MD | Dept of Otolaryngology, University of Oulu, Finland | |
Study Chair: | Olli-Pekka Alho, professor | Dept of Otolaryngology, University of Oulu, Finland |
Responsible Party: | Oulu University Hospital |
ClinicalTrials.gov Identifier: | NCT00547391 |
Other Study ID Numbers: |
Diary nr 106/2007 |
First Posted: | October 22, 2007 Key Record Dates |
Last Update Posted: | April 19, 2012 |
Last Verified: | February 2012 |
adults children tonsillectomy |
Pharyngitis Tonsillitis Pharyngeal Diseases Stomatognathic Diseases |
Respiratory Tract Infections Respiratory Tract Diseases Otorhinolaryngologic Diseases |