Inferior Submucosal Turbinectomy Versus Blunt Turbinectomy for Inferior Turbinate Hypertrophy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Soroka University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00651092
First received: March 30, 2008
Last updated: April 1, 2008
Last verified: March 2008
  Purpose

The aim of the study is to compare endoscopic submucosal inferior turbinectomy to blunt turbinectomy in terms of subjective and objective parameters.


Condition Intervention
Bilateral Inferior Turbinates Hypertrophy
Procedure: bilateral nasal inferior turbinectomy
Procedure: endoscopic submucosal resection of the inferior turbinates

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: to Compare Two Well Popularized Methods of Inferior Nasal Turbinectomy

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • rhinomanometry, saccharine test, nasal endoscopy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A1
since the two methods of turbinectomy are in used on a regular basis there is no way to perform double blind study- both the surgeon and the patients are well aware of the operation they are about to go. we just compare several parameters in patients who are anyway about to undergo an operation in a specific method that is used by their surgeon
Procedure: bilateral nasal inferior turbinectomy
the operation is performed endonasally under general or local anesthesia, the inferior turbinates are resected and removed
Other Name: inferior conchectomy
Active Comparator: A2
the resection of the inferior turbinates will be performed endonasally with an endoscopical instruments
Procedure: endoscopic submucosal resection of the inferior turbinates
surgery of the inferior turbinates- endonasally with endoscopic instruments and by performing submucosal resection of the nasal turbinates
Other Name: submucosal conchectomy

Detailed Description:

The two methods of nasal inferior turbinectomy are well popularized and in use for long periods of time. Endoscopic submucosal inferior turbinectomy is performed in our hospital and blunt turbinectomy is performed usually in privat clinics outside the hospital where there is no endoscopic equipment. We will examine both subjective (QOL questionaire) and objective parameters(rhinomanometry- a non invasive method to evaluate nasal airflow, saccharine test, nasal endoscopy) in our comparison of the outcome of these two methods.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all patients above 18 years

Exclusion Criteria:

  • can not answer a written questionaire
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651092

Contacts
Contact: nili segal, md +972544268202 segalna@012.net.il
Contact: moshe puterman, md +97286400521 puterman@netvision.net.il

Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: nili segal, md soroka university medical center beer sheva israel
  More Information

Publications:
Responsible Party: Dr nili segal, soroke university medical center
ClinicalTrials.gov Identifier: NCT00651092     History of Changes
Other Study ID Numbers: sor466208ctil
Study First Received: March 30, 2008
Last Updated: April 1, 2008
Health Authority: Israel: clalit halth services

Keywords provided by Soroka University Medical Center:
turbinectomy

Additional relevant MeSH terms:
Hypertrophy
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 22, 2014