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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ACTIVE_NOT_RECRUITING
NA
167 participants
INTERVENTIONAL
2019-09-27
2028-12-30
Brief Summary
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Detailed Description
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In our study setting we are comparing intracapsular tonsillectomy (subtotal/intracapsular/partial tonsillectomy (SIPT) ) as the intervention group with extracapsular tonsillectomy as the control group.
SIPT is done with either coblation or microdebrider and TE with monopolar electrosurgery.
Indications for surgery are recurrent tonsillitis or chronic tonsillitis. The patient group is adults (16-65 years)
Safety, efficiency and cost-effectiveness are monitored in a prospective, patient-blinded and randomised study setting.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ECTE/Electrosurgery
Extracapsular tonsillectomy (ECTE) with monopolar electrosurgery
tonsillectomy
removal of tonsil tissue as described in the study arms
ICTE/Microdebrider
Intracapsular tonsillectomy (ICTE) with microdebrider
tonsillectomy
removal of tonsil tissue as described in the study arms
ICTE/Coblator
Intrapsular tonsillectomy (ICTE) with coblator
tonsillectomy
removal of tonsil tissue as described in the study arms
Interventions
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tonsillectomy
removal of tonsil tissue as described in the study arms
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planned tonsil surgery with informed consent
* Recurrent or chronic tonsillitis
Exclusion Criteria
* Acute "hot phase" tonsillitis
* Previous palatine tonsil surgery
* Suspicion or confirmation of malignancy
* High dose analgesics consumption
* Current CPAP-device usage for treatment of OSAS
* Untreated gastro-esophageal reflux disease
* Anticoagulative medication
* Any condition of hemophilia
* Pregnancy, lactation
* Current or positive history of malignant disease (if still active follow-up)
16 Years
65 Years
ALL
No
Sponsors
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Turku University Hospital
OTHER_GOV
Responsible Party
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Jaakko Piitulainen
Consultant
Principal Investigators
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Jussi Jero, Professor
Role: STUDY_DIRECTOR
Turku University Hospital
Locations
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TYKS Korvaklinikka
Turku, , Finland
Countries
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References
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Piitulainen JM, Uusitalo T, Sjoblom HM, Ivaska LE, Jegoroff H, Kauko T, Kokki H, Kyto E, Mansikka I, Ylikoski J, Jero J. Intracapsular tonsillectomy in the treatment of recurrent and chronic tonsillitis in adults: a protocol of a prospective, single-blinded, randomised study with a 5-year follow-up (the FINITE trial). BMJ Open. 2022 Sep 14;12(9):e062722. doi: 10.1136/bmjopen-2022-062722.
Other Identifiers
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T211/2018
Identifier Type: -
Identifier Source: org_study_id
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