Evaluation of Coblation Channeling Treatment for Chronic Tonsillitis.

NCT02981810 | Unknown

• 1 other identifier: 0046-16-HYMC
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate coblation channeling treatment for chronic tonsillitis. Does Tonsillar ablation can create changing in the tonsillar medium for recurrent tonsillar infections and stop the recurrent infections?

Conditions

Chronic Tonsillitis

Keywords

TONSILLAR COBLATION

Outcome Measures

Primary Outcomes (4)

• Change in the number of visits at the doctor due to throat pain- using a questionnaire

  the patient will be asked to report in specific time points in his/hers follow up: after 1 month, 2months, 4 months, 6 months and 12 months

  12 months

• Change in the number of antibiotic treatment was indicated after the procedure- using a questionnaire

  the patient will be asked to report in specific time points in his/hers follow up: after 1 month, 2months, 4 months, 6 months and 12 months

  12 month

• questionnaires to subjectively evaluate the change in patient's discomfort while swallowing

  the patient will be asked to report in specific time points in his/hers follow up: after 1 month, 2months, 4 months, 6 months and 12 months

  12 month

• visual documentation of the pharynx with video camera

  12 month

Secondary Outcomes (2)

• post operative pain assessment via VAS (VISUAL ANALOG SCALE) scores

  up to 7 days

• location and amount of bleeding- post surgical documentation

  up to 7 days

Study Arms (2)

control

ACTIVE COMPARATOR

tonsillectomy

Procedure: tonsillectomy

coblation

EXPERIMENTAL

coblation of the tonsills

Device: Arthrocare® Corporation (ArthroCare Corporation, 7500 Rialto Boulevard Austin, Texas 78735) COBLATION electrode ReFlex Ultra 55*

Interventions

Arthrocare® Corporation (ArthroCare Corporation, 7500 Rialto Boulevard Austin, Texas 78735) COBLATION electrode ReFlex Ultra 55* DEVICE

The treatment was conducted using an Arthrocare® Corporation (ArthroCare Corporation, 7500 Rialto Boulevard Austin, Texas 78735) COBLATION electrode ReFlex Ultra 55\* for tonsillar tissue ablation at low temperatures with only one treatment. All the patients underwent tonsil channeling treatment with coblation, and 4-6 channels were done in each tonsil under local anesthesia, in the operating room. The patients were observed overnight.

coblation

tonsillectomy PROCEDURE

control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients without any chronic diseases other than chronic tonsillitis. Diagnosis of chronic tonsillitis is based on history and medical examination. The criteria are: 1. At least 3 occasions of tonsillitis in the last year that were treated (positive throat swab for Streptococci Group A will contribute towards the diagnosis). 2. Recurrent or chronic throat pain. 3. Hypertrophic tonsils of chronic tonsillitis.

You may not qualify if:

• Disease of the mouth or pharyngeal mucosa-like ulcers.
• Allergy to drugs.
• Gastrointestinal reflux.
• Peritonsillar abscess in the past.
• Pregnant women
• Oncologic patients
• Hematologic disease

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

MeSH Terms

Interventions

Tonsillectomy

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant Proffessor

Study Record Dates

• First Submitted: November 13, 2016
• First Posted: December 5, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 5, 2016

Record last verified: 2016-12