Clinical trial NCT01193790: Evaluation of Coblation Channeling in Treating Chronic Tonsillitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tonsillitis
Keywords: chronic tonsillitis
radio-frequency coblation
radio-frequency coblation in chronic tonsillitis treatment
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-09-02
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators wish to evaluate coblation channeling in the treatment of chronic tonsillitis.

Detailed description: The tonsillar crypts play an important role in chronic tonsillitis. They are covered by stratified epithelium and may be initiated via the epithelium to mount immune responses to various presenting antigens. Go M. et al, investigated the expression and function of tight junctions in the epithelium of human palatine tonsils from patients with tonsillar hypertrophy or recurrent tonsillitis. These studies suggested unique expression of tight junctions in human palatine tonsillar epithelium, and it was suggested that the crypt epithelium may possess an epithelial barrier different from that of the surface epithelium.

Bacteria within biofilms are resistant to host defenses and antibiotics. The presence of bacterial biofilms within the tissue and crypts of inflamed tonsils may explain the chronicity and recurrent characteristics of some forms of tonsillitis. There is strong anatomical evidence for the presence of bacterial biofilms in chronically diseased tonsils.

Our hypothesis was that treatment of the crypts and tonsillar tissue may decrease the possible antigen-immune system interaction and inflammation.

The combination of the radio frequency energy and the fluid creates a "plasma" field containing highly ionized particles. The ionized particles have sufficient energy to break organic molecular bonds that can remove tissue selectively without excessive heat production and damage the surrounding tissue. Employing this new technique, the investigators will try to eliminate the cause for chronic tonsillitis.

The combination of the radio frequency energy and the fluid creates a "plasma" field containing highly ionized particles. The ionized particles have sufficient energy to break organic molecular bonds that can remove tissue selectively without excessive heat production and damage the surrounding tissue. Employing this new technique, the investigators will try to eliminate the cause for chronic tonsillitis.

Our hypothesis was that treatment of the crypts and tonsillar tissue may decrease the possible antigen-immune system interaction and inflammation.

Eligibility criteria: Inclusion Criteria:

* suffering from at least 4 episodes of tonsillitis in past year.
* suffering from recurrent or chronic sore throat.
* suffering from irregular tonsils with crypts, slight redness or enlargement.

Exclusion Criteria:

* suffering from mouth ulcers or other oral מחלת ריריות
* allergic to the type of medication included in the study.
* suffering from gastrointestinal (GI) reflux or chronic הפרשה הוסטנזלית
* contraindication to medical or surgical treatment.
* suffering from peritonsillar abscess.

Primary outcomes:
measure: RF coblation may be promising in treating chronic tonsillitis.
timeFrame: 2 years
Secondary outcomes:
measure: RF coblation reduces tonsillar volume and pain in comparison to surgery; may be performed as an out-patient procedure.
timeFrame: 2 years
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe MC,
Study officials:
References: