Intracapsular Tonsillectomy in Adults

Tonsillitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03654742
• Other study ID #: T211/2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 27, 2019
• Est. completion date: December 30, 2028

Study information

• Verified date: November 2023
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 167
• Est. completion date: December 30, 2028
• Est. primary completion date: January 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Tonsil Disease
• Tonsillitis
• Tonsillitis Acute
• Tonsillitis Chronic

Intervention

Procedure:
• tonsillectomy
removal of tonsil tissue as described in the study arms

Locations

Country	Name	City	State
Finland	TYKS Korvaklinikka	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Life Quality	Quality of life as defined by the questionnaires: Tonsillectomy Outcome Inventory 14 "TOI-14" preoperatively and 6 months after operation;	6 months
Secondary	Residual tonsil tissue	Residual tonsil measured right after surgery is completed and at 6 months follow-up.	6 months
Secondary	Revision surgery	The need of revision surgery after tonsillectomy, recorded with questionnaire: Nordic Tonsil Surgery Register	5 years
Secondary	Throat problems	Throat problems as described by the Nordic Tonsil Surgery Register at different time points postoperatively	5 years
Secondary	Life quality	Quality of life as defined by the questionnaires: Glasgow Benefit Inventory "GBI" at 6 months after operation.	6 months