Intracapsular Tonsillectomy in Adults

Turku University Hospital (TYKS)

Status: Active, not recruiting

Conditions: Tonsillitis; Tonsillitis Chronic; Tonsil Disease; Tonsillitis Acute

Treatments: Procedure: tonsillectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03654742

T211/2018

Details and patient eligibility

About

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

Full 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.

Enrollment: 167 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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167 participants in 3 patient groups

ECTE/Electrosurgery

Active Comparator group

Description:

Extracapsular tonsillectomy (ECTE) with monopolar electrosurgery

Treatment:

Procedure: tonsillectomy

ICTE/Microdebrider

Experimental group

Description:

Intracapsular tonsillectomy (ICTE) with microdebrider

Treatment:

Procedure: tonsillectomy

ICTE/Coblator

Experimental group

Description:

Intrapsular tonsillectomy (ICTE) with coblator

Treatment:

Procedure: tonsillectomy