Nasal Septal Caudal DislocationNCT04323111
Evaluation of Metzenbaum Technique in Correction of Caudal End Nasal Septal Deviation
An observational study of Nasal Septal Caudal Dislocation, run by Assiut University.
Trial summary
To evaluate the results of Metzenbaum 's technique in correction of the Caudal end septal deviation on nasal airway obstruction Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Nasal Septal Caudal Dislocation
- What is being tested?
- metzenbaum's technique
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- All sexes
- Child, Adult
Study population: all adults having nasal airway obstruction due to caudal end nasal septal deviation
Who may be able to join
- 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.
Who cannot join
- Other causes of airway obstruction e.g. nasal polyps, hypertrophied inferior turbinates'
- External nasal deformities
- Contraindications for general anesthesia
Trial locations and contacts
No sites are listed yet.
About this study
- To evaluate the results of Metzenbaum 's technique in correction of the Caudal end septal deviation on nasal airway obstruction
Read the 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.
- Conditions
- Nasal Septal Caudal Dislocation
- Being tested
- metzenbaum's technique
- Keywords
- caudal end nasal septal deviation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metzenbaum's techniqueProcedure or surgery
surgical procedure for correction of caudal end nasal septal deviation
What is being measured
The primary outcome is the main question the study is designed to answer.
the caudal end deviation of the nasal septum corrected is measured by photographic documentation
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
- Little/no photographic evidence of residual caudal septal deviation.
- Marked improvement but was still detectable by careful observation.
- Mild improvement/not improved.
- Made worse after surgical intervention.
Measured: 6 month
air way obstruction which will be be evaluated by The Nasal Obstruction Symptom Evaluation (NOSE) scale score questionnaire
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
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Oct 2020 (estimated)
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nasal Septal Caudal DislocationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madonna Atef Aziz, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323111
- Sponsor's protocol ID
- metzenbaum in caudal end NSD
- Status last verified
- Mar 2020
- First submitted
- 22 Mar 2020
- Last updated
- 26 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 19328887Lal 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.
PubMed 15337107Menegat 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.
PubMed 26187045Haack J, Papel ID. Caudal septal deviation. Otolaryngol Clin North Am. 2009 Jun;42(3):427-36. doi: 10.1016/j.otc.2009.03.005.
PubMed 19486740Sedwick 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.
PubMed 15897403Batioglu-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.
PubMed 25329853
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Metzenbaum Technique in Correction of Caudal End Nasal Septal Deviation
- ClinicalTrials.gov ID
- NCT04323111
- Acronym / sponsor ID
- metzenbaum in caudal end NSD
- Conditions
- Nasal Septal Caudal Dislocation
- Keywords
- caudal end nasal septal deviation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To evaluate the results of Metzenbaum 's technique in correction of the Caudal end septal deviation on nasal airway obstruction
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- all adults having nasal airway obstruction due to caudal end nasal septal deviation
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Other causes of airway obstruction e.g. nasal polyps, hypertrophied inferior turbinates'
- External nasal deformities
- Contraindications for general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metzenbaum's techniquesurgical procedure for correction of caudal end nasal septal deviation | Procedure or surgery | – |
Primary outcome
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Background: PubMed 19328887Chandra 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.
- Background: PubMed 15337107Lal 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.
- Background: PubMed 26187045Menegat 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.
- Background: PubMed 19486740Haack J, Papel ID. Caudal septal deviation. Otolaryngol Clin North Am. 2009 Jun;42(3):427-36. doi: 10.1016/j.otc.2009.03.005.
- Background: PubMed 15897403Sedwick 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.
- Background: PubMed 25329853Batioglu-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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Septal Caudal Dislocation, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact madonna atef aziz (01275844850, didotoffy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the caudal end deviation of the nasal septum corrected is measured by photographic documentation (time frame: 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04323111, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.