Clinical Trials Directory

Trials / Unknown

UnknownNCT02312947

Coblation Versus Cold Adenoidectomy -Safety and Efficiency

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Hillel Yaffe Medical Center · Other Government
Sex
All
Age
12 Months – 10 Years
Healthy volunteers
Accepted

Summary

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

Detailed 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.

Conditions

Interventions

TypeNameDescription
DEVICEcoblation (COBLATION II surgery system ,CE8001-01)comparison of two methods of operation : coblation and cold dissection
DEVICEcold dissection adenoidectomycomparison of two methods of operation : coblation and cold dissectionby currete

Timeline

Start date
2014-12-01
Primary completion
2014-12-01
Completion
2016-12-01
First posted
2014-12-09
Last updated
2014-12-09

Source: ClinicalTrials.gov record NCT02312947. Inclusion in this directory is not an endorsement.