Intracapsular Tonsillectomy in Adults

Study Overview
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Brief Summary
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Comparing the classical extracapsular tonsillectomy (TE) performed with electrosurgery to intracapsular approaches (SIPT) by coblation or microdebrider. The patient group is adults with recurrent or chronic tonsillitis

Detailed Description
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Extracapsular tonsillectomy (TE) with monopolar electrosurgery is the most commonly used approach in adult tonsil surgery in Turku University Central Hospital, Finland. In our study setting we are comparing intracapsular tonsillectomy (subtotal/intracapsular/partial tonsillectomy (SIPT) ) as the intervention group with extracapsular tonsillectomy as the control group. SIPT is done with either coblation or microdebrider and TE with monopolar electrosurgery. Indications for surgery are recurrent tonsillitis or chronic tonsillitis. The patient group is adults (16-65 years) Safety, efficiency and cost-effectiveness are monitored in a prospective, patient-blinded and randomised study setting.

Official Title
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Intracapsular vs Extracapsular Tonsillectomy. A Comparison of Treatment Methods of Recurrent and Chronic Tonsillitis in Adults: a Prospective Single-blinded Randomised Study

Conditions
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Tonsil Disease, Tonsillitis, Tonsillitis Acute, Tonsillitis Chronic

Intervention / Treatment
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* Procedure: tonsillectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 16-65 years Planned tonsil surgery with informed consent Recurrent or chronic tonsillitis Exclusion Criteria: Less than 1 month old, drained quinsy Acute hot phase tonsillitis Previous palatine tonsil surgery Suspicion or confirmation of malignancy High dose analgesics consumption Current CPAP-device usage for treatment of OSAS Untreated gastro-esophageal reflux disease Anticoagulative medication Any condition of hemophilia Pregnancy, lactation Current or positive history of malignant disease (if still active follow-up)

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, single-blinded, randomised, controlled
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ECTE/Electrosurgery<br>Extracapsular tonsillectomy (ECTE) with monopolar electrosurgery | Procedure: tonsillectomy<br>* removal of tonsil tissue as described in the study arms<br>* Other names: tonsil surgery;|
| Experimental: ICTE/Microdebrider<br>Intracapsular tonsillectomy (ICTE) with microdebrider | Procedure: tonsillectomy<br>* removal of tonsil tissue as described in the study arms<br>* Other names: tonsil surgery;|
| Experimental: ICTE/Coblator<br>Intrapsular tonsillectomy (ICTE) with coblator | Procedure: tonsillectomy<br>* removal of tonsil tissue as described in the study arms<br>* Other names: tonsil surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative recovery | Pain post-operatively after discharge as self-reported pain intensity over the past day. Each day is scored with the modified Brief Pain Inventory and recovery is achieved when pain score reaches preset values. Recovery speed defined as pain VAS-score 3 or less at rest; or pain VAS-score 5 or less without regular analgesics use. Daily questionnaire used: Brief Pain Inventory. | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesics use | Need for analgesics postoperatively during 21 days. Measured as number of naprometin tablets/ day and the number of tramadol-paracetamol combination tablets/day. | 21 days | 
| Post-operative bleeding | Bleeding post-operatively at the ward or at any point during 21 days. Measured as 1-4 (1= bleeding, stopped spontaneously, no contact with staff; 2: Contact with ER, bleeding stopped without intervention; 3: Bleeding, needed intervention (packing, topical adrenalin, electrosurgical hemostasis; 4: Needed OR-time, blood transfusion, ward days | 21 days | 
| Life Quality | Quality of life as defined by the questionnaires: Tonsillectomy Outcome Inventory 14 TOI-14 preoperatively and 6 months after operation; | 6 months | 
| Residual tonsil tissue | Residual tonsil measured right after surgery is completed and at 6 months follow-up. | 6 months | 
| Revision surgery | The need of revision surgery after tonsillectomy, recorded with questionnaire: Nordic Tonsil Surgery Register | 5 years | 
| Throat problems | Throat problems as described by the Nordic Tonsil Surgery Register at different time points postoperatively | 5 years | 
| Life quality | Quality of life as defined by the questionnaires: Glasgow Benefit Inventory GBI at 6 months after operation. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tonsil surgery, tonsillectomy, intracapsular, microdebrider, coblation, extracapsular, electrosurgery, electrocautery, adults