Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults

NCT ID: NCT04314492

Last Updated: 2025-04-25

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

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2025-01-31

Brief Summary

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Treating sleep apnea in adults caused by tonsillar hypertrophy with intracapsular tonsillectomy by coblation

Detailed Description

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The investigators aim to study if good surgical results can be achieved by intracapsular tonsillectomy with coblation while monitoring safety, efficiency and cost-effectiveness. In adult tonsil surgery, the current practice in Finland is commonly extracapsular tonsillectomy with monopolar electrosurgery.

Conditions

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Tonsillar Hypertrophy Sleep Apnea, Obstructive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intracapsular tonsillectomy with coblation

(Total) Intracapsular tonsillectomy (ICTE) with coblation

Group Type EXPERIMENTAL

Tonsillectomy

Intervention Type PROCEDURE

Intracapsular removal of tonsillar tissue (\>90%) with coblation

Interventions

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Tonsillectomy

Intracapsular removal of tonsillar tissue (\>90%) with coblation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age 16-64
* Planned tonsil surgery with informed concent
* Obstructive sleep apnea (AHI \> 15)
* Tonsillar size of 3-4 on the Friedman scale

Exclusion Criteria

* BMI \> 35 (Based on finnish Käypä Hoito -recommendations)
* Central sleep apnea
* Weight loss of more than 10% within the study period
* Untreated obstruction of nasal breathing
* Treated peritonsillar abscess \<1 month before enrollment
* Active tonsillar infection
* Previous tonsillar surgery (excluding incision of abscess)
* Malignancy
* High use of analgesics \>1 DDD daily during last 4 weeks
* Untreated reflux
* Anticoagulative medication
* Any condition of hemophilia
* Pregnancy, lactation
* Other, evaluated by treating physician
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, Doctor of Medical Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jussi Jero, Professor

Role: STUDY_DIRECTOR

University of Turku

Jaakko Piitulainen, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

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Satasairaala

Pori, Satakunta, Finland

Site Status

Turku University Hospital

Turku, Southwest Finland, Finland

Site Status

Countries

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Finland

Other Identifiers

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T62/2020

Identifier Type: -

Identifier Source: org_study_id

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