Coblation Versus Cold Adenoidectomy -Safety and Efficiency

Sleep Apnea, Obstructive Clinical Trial

Official title:

Coblation Versus Cold Adenoidectomy -Safety and Efficiency

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02312947
• Other study ID #: 0047-14-HYMC
• Status: Not yet recruiting
• Phase: N/A
• First received: December 6, 2014
• Last updated: December 8, 2014
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2014
• Source: Hillel Yaffe Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Comparative two methods of adenoidectomy means the coblation adenoidectomy with the cold dissection adenoidectomy specifically inquire which method is safer and more efficient.

Description:

Obstructive sleep apnea(osa) in children is a very bother and frequent problem with clinical and behavioral impacts. The hypertrophied adenoid tissue obstructs the air way in the nasopharynx that initiates the common symptoms. The treatment from that concerning problems is in the operation rooms by diversity surgical methods, the very older one is the cold dissection adenoidectomy.

Recently many surgeons use the coblation system as a preferred method for adenoidectomy. This method was proof as a safe and efficient especially referring to the bleeding and the dehydration risk .

Many children that operated by the cold dissection forced to perform another one or two operations presumably due to the adenoid tissue that did not removed completely from the first operation .

our hypothesis is that the coblation systemis a safe and eficient method for adenoidectomy.

The aims of this project is to verify if our theory is corect by blinded comparision between two methods.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 10 Years

Eligibility

Inclusion Criteria:

• children with obstructive symptoms

• the children must perform nasopharyngoscopy with clear evidence of obstructive symptoms ( video or polysomnography more than 5 RDI)

Exclusion Criteria:

• without any recent upper respiratory tract infection or clinical suspicious of adenoiditis.

• tonsillectomy

• Non randomalization, not blinded

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep Apnea, Obstructive

Intervention

Device:
• coblation (COBLATION II surgery system ,CE8001-01)
comparison of two methods of operation : coblation and cold dissection
• cold dissection adenoidectomy
comparison of two methods of operation : coblation and cold dissectionby currete

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety (bleeding , dehydration or any other complications)	measure the event of bleeding , dehydration or any other complications	percent of bleeding and dehydration	Yes
Secondary	efficacy (pain post operation by scales evaluation)	pain post operation by scales evaluation and determination whether adenoid tissue left behind after each methods of operation	pain and examination for residual adenoid tissue	Yes