Evaluation of Metzenbaum Technique in Correction of Caudal End Nasal Septal Deviation

March 24, 2020 updated by: Madonna Atef Aziz, Assiut University
• To evaluate the results of Metzenbaum 's technique in correction of the Caudal end septal deviation on nasal airway obstruction

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Detailed Description

Deviation of Nasal septum in different parts may have various functional or aesthetic effects . The etiology of a deviated septum is generally congenital, but may also be as a result of trauma or iatrogenic causes. Most important is the Caudal septal deviation which narrows the airway and impairs major mechanisms supporting the tip, leading to tip-ptosis and airway collapse. .The correction of caudal septal deviations can be a challenging problem so many techniques have been described and tested to correct caudal septal deflections . Attempts to correct nasal septal deformities were described in the medical literature as early as the late 19th century , and till now there is not one specific technique that is agreed upon by surgeons worldwide.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

14 years to 43 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all adults having nasal airway obstruction due to caudal end nasal septal deviation

Description

Inclusion Criteria:

  • Patients presenting to Assiut University Clinic of Otolaryngology department.
  • Aging from 16 to 45 years old
  • Patients complaining of nasal airway obstruction causes by caudal septal deviation.

Exclusion Criteria:

  • Other causes of airway obstruction e.g. nasal polyps, hypertrophied inferior turbinates'
  • External nasal deformities
  • Contraindications for general anesthesia

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the caudal end deviation of the nasal septum corrected is measured by photographic documentation
Time Frame: 6 month

Photographs will be taken in the 6 dimensional (frontal,basal, lateral and oblique) views of the nose at two points ,First photograph set will be taken in preoperative period. The second photograph set will taken at six months follow up. Both these photographs will be shown to the patient and he/she was asked to give a score to rate the difference in appearance on a 4 point scale 4 point scale for evaluating postoperative outcome

  1. Little/no photographic evidence of residual caudal septal deviation.
  2. Marked improvement but was still detectable by careful observation.
  3. Mild improvement/not improved.
  4. Made worse after surgical intervention.
6 month
air way obstruction which will be be evaluated by The Nasal Obstruction Symptom Evaluation (NOSE) scale score questionnaire
Time Frame: 2 month
The Nasal Obstruction Symptom Evaluation (NOSE) scale score is a questionnaire that each patient will take to compare the symptoms of air way obstruction improvement after surgery . the patients will take it at two points , first in pre - operative assessment and second in post operative follow up after 2 month
2 month

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Anticipated)

October 1, 2020

Primary Completion (Anticipated)

October 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

March 22, 2020

First Submitted That Met QC Criteria

March 24, 2020

First Posted (Actual)

March 26, 2020

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • metzenbaum in caudal end NSD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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