Sleep Apnea, Obstructive, Tonsillar Hypertrophy
Conditions
Keywords
tonsil surgery, tonsillectomy, obstructive sleep apnea, coblation, intracapsular
Brief summary
Treating sleep apnea in adults caused by tonsillar hypertrophy with intracapsular tonsillectomy by coblation
Detailed description
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.
Interventions
PROCEDURETonsillectomy
Intracapsular removal of tonsillar tissue (\>90%) with coblation
Sponsors
Turku University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-hypopnea index | 6 months | Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life measured by Nordic tonsil surgery register questionnaire | 6 months - up to 5 years | Questions regarding postoperative complications and perceived symptom relief after 180 days. Yes/no questions and open questions, no score. |
| Quality of life measured by Epworth sleepiness scale | 6 months - up to 5 years | Questions regarding sleepiness. Score 0-24, lower is better. |
| Post-operative recovery | 21 days | Recovery speed defined as score 3 or less at rest; or 5 or less without regular analgesics use, questionnaire used: Brief Pain Inventory. |
| Total recovery of obstructive sleep apnea | 6 months and 24 months and 60 months | Defined by apnea-hypopnea index \<5 post-operatively in polysomnography. |
| Quality of life measured by Glasgow Benefit Inventory | 6 months and 24 month and 60 months | General quality of life questionnaire. 18 questions, score 1-5 in each question, higher is better. |
| Apnea-index | 6 months and 24 months and 60 months | Post-operative apnea index reduction by 50% compared to preoperative values in polysomnography. |
| Snoring time | 6 months and 24 months and 60 months | Post-operative reduction of snoring time in preoperative polysomnography compared to post-operative values in |
| Regrowth of tonsillar tissue | Pre-operative to 6 months | Measured by photography, Friedman scale (0-4, lower is smaller). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Apnea-hypopnea index | 24 months | Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography. |
Countries
Finland
Outcome results
None listed