Intracapsular Tonsillectomy in Adults

NCT ID: NCT03654742

Last Updated: 2025-09-10

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-27

Study Completion Date

2028-12-30

Brief Summary

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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

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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.

Conditions

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Tonsil Disease Tonsillitis Tonsillitis Acute Tonsillitis Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, single-blinded, randomised, controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Patients are masked with numbers and patient records not shown to the outcomes assessor

Study Groups

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ECTE/Electrosurgery

Extracapsular tonsillectomy (ECTE) with monopolar electrosurgery

Group Type ACTIVE_COMPARATOR

tonsillectomy

Intervention Type PROCEDURE

removal of tonsil tissue as described in the study arms

ICTE/Microdebrider

Intracapsular tonsillectomy (ICTE) with microdebrider

Group Type EXPERIMENTAL

tonsillectomy

Intervention Type PROCEDURE

removal of tonsil tissue as described in the study arms

ICTE/Coblator

Intrapsular tonsillectomy (ICTE) with coblator

Group Type EXPERIMENTAL

tonsillectomy

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Other Intervention Names

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tonsil removal tonsil surgery

Eligibility Criteria

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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)
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jaakko Piitulainen

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jussi Jero, Professor

Role: STUDY_DIRECTOR

Turku University Hospital

Locations

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TYKS Korvaklinikka

Turku, , Finland

Site Status

Countries

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Finland

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.

Reference Type BACKGROUND
PMID: 36104143 (View on PubMed)

Other Identifiers

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T211/2018

Identifier Type: -

Identifier Source: org_study_id

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