Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults

Turku University Hospital25 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tonsillar Hypertrophy Sleep Apnea, Obstructive

Interventions

TonsillectomyPROCEDURE

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

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Satasairaala

Pori, Satakunta, Finland

Turku University Hospital

Turku, Southwest Finland, Finland

Outcomes

Primary Outcomes

Apnea-hypopnea index

Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography.

Time frame: 6 months

Secondary Outcomes

Quality of life measured by Glasgow Benefit Inventory

General quality of life questionnaire. 18 questions, score 1-5 in each question, higher is better.

Time frame: 6 months and 24 month and 60 months

Quality of life measured by Nordic tonsil surgery register questionnaire

Questions regarding postoperative complications and perceived symptom relief after 180 days. Yes/no questions and open questions, no score.

Time frame: 6 months - up to 5 years

Quality of life measured by Epworth sleepiness scale

Questions regarding sleepiness. Score 0-24, lower is better.

Time frame: 6 months - up to 5 years

Post-operative recovery

Recovery speed defined as score 3 or less at rest; or 5 or less without regular analgesics use, questionnaire used: Brief Pain Inventory.

Time frame: 21 days

Total recovery of obstructive sleep apnea

Defined by apnea-hypopnea index \<5 post-operatively in polysomnography.

Time frame: 6 months and 24 months and 60 months

Regrowth of tonsillar tissue

Measured by photography, Friedman scale (0-4, lower is smaller).

Time frame: Pre-operative to 6 months

Data from ClinicalTrials.gov

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