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Coblation Versus Cold Adenoidectomy -Safety and Efficiency

NCT ID: NCT02312947

Last Updated: 2014-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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

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Sleep Apnea, Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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coblation

coblation adenoidectomy

Group Type ACTIVE_COMPARATOR

coblation (COBLATION II surgery system ,CE8001-01)

Intervention Type DEVICE

comparison of two methods of operation : coblation and cold dissection

cold dissection

cold dissection adenoidectomy

Group Type ACTIVE_COMPARATOR

cold dissection adenoidectomy

Intervention Type DEVICE

comparison of two methods of operation : coblation and cold dissectionby currete

Interventions

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coblation (COBLATION II surgery system ,CE8001-01)

comparison of two methods of operation : coblation and cold dissection

Intervention Type DEVICE

cold dissection adenoidectomy

comparison of two methods of operation : coblation and cold dissectionby currete

Intervention Type DEVICE

Other Intervention Names

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COBLATION II surgery system ,CE8001-01 currete adenoidectomy

Eligibility Criteria

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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
Minimum Eligible Age

12 Months

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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0047-14-HYMC

Identifier Type: -

Identifier Source: org_study_id