Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2017-10-24
2022-02-02
Brief Summary
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Detailed Description
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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:
* We are looking for a 40% absolute difference in cure rate between tonsillotomy (90%) and follow up (50%) groups.
* Two sided Whitehead design
* Maximum likelihood estimation (MLE)
* Five assessments (sample size 4+4, 8+8. 12+12, 16+16 and 19+19)
* type 1 error 5 % and power 80%
* The sample size will be from 8 to 38 patients depending on when the trial can be stopped along assessments.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Tonsillotomy
The patients diagnosed with PFAPA will have tonsillotomy performed in one month from randomisation.
Tonsillotomy
About 2/3 of the palatine tonsil tissue is removed with coplator or bipolar knife.
Follow up
The patients diagnosed with PFAPA will be monitored for 3 months time. If the symptoms still persist, tonsillectomy will be performed
No interventions assigned to this group
Interventions
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Tonsillotomy
About 2/3 of the palatine tonsil tissue is removed with coplator or bipolar knife.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Year
12 Years
ALL
No
Sponsors
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Oulu University Hospital
OTHER
Tampere University
OTHER
Tampere University Hospital
OTHER
Turku University Hospital
OTHER_GOV
University of Turku
OTHER
University of Oulu
OTHER
Responsible Party
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Locations
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Oulu Unversity Hospital
Oulu, , Finland
Tampere University Hospital
Tampere, , Finland
Turku University Hospital
Turku, , Finland
Countries
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Other Identifiers
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TT 50_2017
Identifier Type: -
Identifier Source: org_study_id
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