Clinical trial NCT03654742: Intracapsular Tonsillectomy in Adults
Official title: Intracapsular vs Extracapsular Tonsillectomy. A Comparison of Treatment Methods of Recurrent and Chronic Tonsillitis in Adults: a Prospective Single-blinded Randomised Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tonsil Disease
Tonsillitis
Tonsillitis Acute
Tonsillitis Chronic
Keywords: tonsil surgery
tonsillectomy
intracapsular
microdebrider
coblation
extracapsular
electrosurgery
electrocautery
adults
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2018-08-31
Enrollment: 167
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, single-blinded, randomised, controlled
Primary purpose: TREATMENT

Brief summary: Comparing the classical extracapsular tonsillectomy (TE) performed with electrosurgery to intracapsular approaches (SIPT) by coblation or microdebrider. The patient group is adults with recurrent or chronic tonsillitis

Detailed description: Extracapsular tonsillectomy (TE) with monopolar electrosurgery is the most commonly used approach in adult tonsil surgery in Turku University Central Hospital, Finland.

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.

Eligibility criteria: Inclusion Criteria:

* Age 16-65 years
* Planned tonsil surgery with informed consent
* Recurrent or chronic tonsillitis

Exclusion Criteria:

* Less than 1 month old, drained quinsy
* 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)

Primary outcomes:
measure: Post-operative recovery
timeFrame: 21 days
Secondary outcomes:
measure: Analgesics use
timeFrame: 21 days
measure: Post-operative bleeding
timeFrame: 21 days
measure: Life Quality
timeFrame: 6 months
measure: Residual tonsil tissue
timeFrame: 6 months
measure: Revision surgery
timeFrame: 5 years
measure: Throat problems
timeFrame: 5 years
measure: Life quality
timeFrame: 6 months
Other outcomes:
Locations:
city: Turku
country: Finland
facility: TYKS Korvaklinikka
Study officials:
affiliation: Turku University Hospital
name: Jussi Jero, Professor
role: STUDY_DIRECTOR
References:
citation: 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.