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| Name | Class |
|---|---|
| Oulu University Hospital | OTHER |
| Tampere University | OTHER |
| Tampere University Hospital | OTHER |
| Turku University Hospital |
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Children with periodic fever, aphthous stomatitis, pharyngitis, adenitis (PFAPA) -syndrome diagnosis will be randomised either to tonsillotomy (partial tonsillectomy) or 3 months follow up. At follow up visit 3 months after randomisation the children from either groups with ongoing symptoms will be sent to tonsillectomy.
Children with periodic fever, aphthous stomatitis, pharyngitis, adenitis (PFAPA) -syndrome diagnosis will be randomised either to tonsillotomy (partial tonsillectomy) or 3 months follow up.
In both groups the symptoms are monitored with symptom diaries. At follow up visit 3 months after randomisation the children from either groups with ongoing symptoms will be sent to tonsillectomy (total remove of palatine tonsil).
The design is sequential trial. From the previous trials we know that the effect of tonsillectomy is about 90% and that during follow up for six months as much as 50% of the patients will recover. Because the syndrome is rare and because the rescue operations of the tonsils (tonsillectomy in a person who has gone through tonsillotomy), the sample size has to be as low as possible. That is the reason why we chose sequential design, with assessments after every 8 patient.
Randomization is made in blocks of four. In sequential design we use the following assumptions:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tonsillotomy | Experimental | The patients diagnosed with PFAPA will have tonsillotomy performed in one month from randomisation. |
|
| Follow up | No Intervention | The patients diagnosed with PFAPA will be monitored for 3 months time. If the symptoms still persist, tonsillectomy will be performed |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tonsillotomy | Procedure | About 2/3 of the palatine tonsil tissue is removed with coplator or bipolar knife. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cure | Proportion of patients who do not have any PFAPA symptoms | 3 months from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Rescue surgery | Proportion of patients needing rescue surgery (tonsillectomy) | 12 months from randomization |
| Days with fever | Number of days with fever >38C in symptom diaries |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu Unversity Hospital | Oulu | Finland | ||||
| Tampere University Hospital |
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| ID | Term |
|---|---|
| C536025 | Marshall syndrome |
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| OTHER_GOV |
| University of Turku | OTHER |
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| 3 months from randomization |
| Cure | Proportion of patients who do not have any PFAPA symptoms | 6 months from randomization |
| Tampere |
| Finland |
| Turku University Hospital | Turku | Finland |