Coblation Versus Cold Adenoidectomy -Safety and Efficiency

December 8, 2014 updated by: Hillel Yaffe Medical Center
Comparative two methods of adenoidectomy means the coblation adenoidectomy with the cold dissection adenoidectomy specifically inquire which method is safer and more efficient.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: coblation
coblation adenoidectomy
Device: coblation (COBLATION II surgery system ,CE8001-01)
comparison of two methods of operation : coblation and cold dissection
Other Names:
  • COBLATION II surgery system ,CE8001-01
Active Comparator: cold dissection
cold dissection adenoidectomy
Device: cold dissection adenoidectomy
comparison of two methods of operation : coblation and cold dissectionby currete
Other Names:
  • currete adenoidectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety (bleeding , dehydration or any other complications)
Time Frame: percent of bleeding and dehydration
measure the event of bleeding , dehydration or any other complications
percent of bleeding and dehydration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy (pain post operation by scales evaluation)
Time Frame: pain and examination for residual adenoid tissue
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

December 6, 2014

First Submitted That Met QC Criteria

December 8, 2014

First Posted (Estimate)

December 9, 2014

Study Record Updates

Last Update Posted (Estimate)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 8, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0047-14-HYMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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