Tonsil Disease, Tonsillitis, Tonsillitis Acute, Tonsillitis Chronic
Conditions
Keywords
tonsil surgery, tonsillectomy, intracapsular, microdebrider, coblation, extracapsular, electrosurgery, electrocautery, adults
Brief summary
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
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.
Interventions
PROCEDUREtonsillectomy
removal of tonsil tissue as described in the study arms
Sponsors
Turku University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients are masked with numbers and patient records not shown to the outcomes assessor
Intervention model description
prospective, single-blinded, randomised, controlled
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative recovery | 21 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative bleeding | 21 days | 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 |
| Life Quality | 6 months | Quality of life as defined by the questionnaires: Tonsillectomy Outcome Inventory 14 TOI-14 preoperatively and 6 months after operation; |
| Residual tonsil tissue | 6 months | Residual tonsil measured right after surgery is completed and at 6 months follow-up. |
| Analgesics use | 21 days | Need for analgesics postoperatively during 21 days. Measured as number of naprometin tablets/ day and the number of tramadol-paracetamol combination tablets/day. |
| Throat problems | 5 years | Throat problems as described by the Nordic Tonsil Surgery Register at different time points postoperatively |
| Life quality | 6 months | Quality of life as defined by the questionnaires: Glasgow Benefit Inventory GBI at 6 months after operation. |
| Revision surgery | 5 years | The need of revision surgery after tonsillectomy, recorded with questionnaire: Nordic Tonsil Surgery Register |
Countries
Finland
Outcome results
None listed