- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04323111
Evaluation of Metzenbaum Technique in Correction of Caudal End Nasal Septal Deviation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: madonna atef aziz
- Phone Number: 01275844850
- Email: didotoffy@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
|
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
Sponsor
Publications and helpful links
General Publications
- Chandra RK, Patadia MO, Raviv J. Diagnosis of nasal airway obstruction. Otolaryngol Clin North Am. 2009 Apr;42(2):207-25, vii. doi: 10.1016/j.otc.2009.01.004.
- Lal D, Corey JP. Acoustic rhinometry and its uses in rhinology and diagnosis of nasal obstruction. Facial Plast Surg Clin North Am. 2004 Nov;12(4):397-405, v. doi: 10.1016/j.fsc.2004.04.002.
- Menegat F, Monnazzi MS, Silva BN, de Moraes M, Gabrielli MA, Pereira-Filho VA. Assessment of nasal obstruction symptoms using the NOSE scale after surgically assisted rapid maxillary expansion. Int J Oral Maxillofac Surg. 2015 Nov;44(11):1346-50. doi: 10.1016/j.ijom.2015.06.018. Epub 2015 Jul 15.
- Haack J, Papel ID. Caudal septal deviation. Otolaryngol Clin North Am. 2009 Jun;42(3):427-36. doi: 10.1016/j.otc.2009.03.005.
- Sedwick JD, Lopez AB, Gajewski BJ, Simons RL. Caudal septoplasty for treatment of septal deviation: aesthetic and functional correction of the nasal base. Arch Facial Plast Surg. 2005 May-Jun;7(3):158-62. doi: 10.1001/archfaci.7.3.158.
- Batioglu-Karaaltin A, Yigit O, Donmez Z. A new persistent suture technique for correction of caudal septal dislocation. J Craniofac Surg. 2014 Nov;25(6):2169-71. doi: 10.1097/SCS.0000000000000893.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- metzenbaum in caudal end NSD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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