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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intracapsular tonsillectomy with coblation | Experimental | (Total) Intracapsular tonsillectomy (ICTE) with coblation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tonsillectomy | Procedure | Intracapsular removal of tonsillar tissue (>90%) with coblation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-hypopnea index | Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography. | 6 months |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-hypopnea index | Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography. | 24 months |
| Apnea-hypopnea index | Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jussi Jero, Professor | University of Turku | Study Director |
| Jaakko Piitulainen, M.D., Ph.D. | Turku University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Satasairaala | Pori | Satakunta | 28500 | Finland | ||
| Turku University Hospital |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D014068 | Tonsillectomy |
| ID | Term |
|---|---|
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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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 |
| 60 months |
| Turku |
| Southwest Finland |
| 20521 |
| Finland |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |