Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults

Study Overview
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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.

Official Title
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Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults

Conditions
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Tonsillar Hypertrophy, Sleep Apnea, Obstructive

Intervention / Treatment
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* Procedure: Tonsillectomy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracapsular tonsillectomy with coblation<br>(Total) Intracapsular tonsillectomy (ICTE) with coblation | Procedure: Tonsillectomy<br>* Intracapsular removal of tonsillar tissue (>90%) with coblation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-hypopnea index | Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life measured by Glasgow Benefit Inventory | General quality of life questionnaire. 18 questions, score 1-5 in each question, higher is better. | 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. | 6 months - up to 5 years | 
| Quality of life measured by Epworth sleepiness scale | Questions regarding sleepiness. Score 0-24, lower is better. | 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. | 21 days | 
| Total recovery of obstructive sleep apnea | Defined by apnea-hypopnea index <5 post-operatively in polysomnography. | 6 months and 24 months and 60 months | 
| Regrowth of tonsillar tissue | Measured by photography, Friedman scale (0-4, lower is smaller). | Pre-operative to 6 months | 
| Apnea-index | Post-operative apnea index reduction by 50% compared to preoperative values in polysomnography. | 6 months and 24 months and 60 months | 
| Snoring time | Post-operative reduction of snoring time in preoperative polysomnography compared to post-operative values in | 6 months and 24 months and 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tonsil surgery, tonsillectomy, obstructive sleep apnea, coblation, intracapsular