Nasal Septal DeviationNCT04579042
Cartilaginous Batten Graft Septoplasty in Caudal Septal Deviation
A study testing cartilaginous batten graft septoplasty in people with Nasal Septal Deviation, run by Benha University at 1 site in Egypt.
Trial summary
To evaluate the clinical outcomes of septoplasty using cartilaginous batten graft in cases with caudal septal deviation as regards the relieve of nasal obstruction and aesthetic results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Septal Deviation
- What is being tested?
- cartilaginous batten graft septoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Oct 2020to 1 Mar 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient presented with nasal obstruction or disfigurement due to anterocaudal septal deviation.
Who cannot join
- Previous septal surgery
- Deformed nose, which necessitate external rhinoplasty approach.
- Other endonasal cause of nasal obstruction other than deviated nasal septum
- Bleeding disorder or systemic diseases.
- Patient who will not complete the follow up periods.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Benha University Hospital, Faculty of Medicine
Banhā, Qalyubia Governorate, 13512
About this study
Official title: Clinical Outcomes After Septoplasty Using Cartilaginous Batten Graft in The Management of The Caudal Septal Deviation
To evaluate the clinical outcomes of septoplasty using cartilaginous batten graft in cases with caudal septal deviation as regards the relieve of nasal obstruction and aesthetic results.
Read the detailed description
A prospective study will be conducted over 15 patients indicated for septoplasty.
Preoperative assessment:
History
- NOSE (nasal obstruction septoplasty effectiveness score): Higher NOSE scores indicate worse nasal obstruction (range: 0-100).
- Visual analogue scale (VAS) (0-10) of nasal obstruction:For nasal obstruction
Examination:
- Anterior rhinoscopy: to confirm caudal septal deviation.
- Endoscopic nasal examination: to exclude HIT, polyp, mass and discharge.
- Basal view photograph.
- CT nose and paranasal sinuses to exclude other pathology.
Operative procedures:
- General anesthesia.
- Hemitransfixtion incision on the concave side
- The mucoperichondrial flap of the septum will be elevated
- A contralateral flap will be elevated from the caudal aspect of the cartilage
- Subperichondrial dissection into the nasal floor
- The curved portion of the septal cartilage will be harvested by excision, leaving an L-strut of dorsal and caudal cartilaginous septum
- A caudal septal batten graft created from harvested septal cartilage, then will be sutured using three or four stitches (5-0 polydioxanone sutures).
- If C-shaped caudal deviation without angulation or dislocation, cartilaginous batten graft fixed on the concave side
- If there is angulation of caudal septal end, the caudal strut will be cut by scissors at the most convex point in the caudocephalic direction. Excessive lower and upper caudal struts will be overlapped and sutured together with batten graft
- If dislocated, the septal cartilage will be separated from the anterior nasal spine (ANS) and maxillary crest for reposition. If there is an excessive cartilage portion, it will be removed and then the graft will be sutured
- The hemitransfixion incision will be closed using 5-0 Vicryl
- Internal nasal splint and anterior nasal pack will be placed in both sides
- Conditions
- Nasal Septal Deviation
- Being tested
- cartilaginous batten graft septoplasty
- Keywords
- Caudal septal deviation, Batten graft, Septoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cartilaginous batten graft septoplastyProcedure or surgery
Also called batten graft septoplasty
septoplasty using cartilaginous batten graft in cases with caudal septal deviation
| Study group | Role | What they receive |
|---|---|---|
| Septoplasty Using Cartilaginous Batten Graft | Experimental | septoplasty using cartilaginous batten graft in cases with caudal septal deviation Receives: Procedure: cartilaginous batten graft septoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal obstruction
We will use the validated Nasal obstruction septoplasty effectiveness score: (range: 0-100) Higher NOSE scores indicate worse nasal obstruction.
Measured: 3 months
Secondary outcomes (1)
Aesthetic results
Basal view photography:
Two independent observers will review the photographs and 4-point grading system will be used to evaluate results:
- Grade I: Will indicate that the patient has little or no photographic evidence of residual caudal septal deviation.
- Grade II: The caudal septal deviation show marked improvement but still detectable by careful observation.
- Grade III: The caudal deviation is only mildly improved or not improved from the preoperative assessment.
- Grade IV: The caudal deviation is worse after surgical intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start7 Oct 2020
- Primary completion1 Jan 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nasal Septal DeviationStudies of the same condition, open and under way.
- More trials run by Benha 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Ahmed Abdelalim, Benha University
- Investigators
- Abdelrahman A Abdelalim, MD, Principal investigator, Benha UniversityAshraf S El-Hamshary, MD, Study chair, Benha UniversityIbrahim S Reyad, Resident, Study chair, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579042
- Sponsor's protocol ID
- MS 40-1-2020
- Status last verified
- Mar 2023
- First submitted
- 1 Oct 2020
- Last updated
- 6 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004 Feb;130(2):157-63. doi: 10.1016/j.otohns.2003.09.016.
PubMed 14990910Chung YS, Seol JH, Choi JM, Shin DH, Kim YW, Cho JH, Kim JK. How to resolve the caudal septal deviation? Clinical outcomes after septoplasty with bony batten grafting. Laryngoscope. 2014 Aug;124(8):1771-6. doi: 10.1002/lary.24491. Epub 2013 Dec 9.
PubMed 24323627
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes After Septoplasty Using Cartilaginous Batten Graft in The Management of The Caudal Septal Deviation
- ClinicalTrials.gov ID
- NCT04579042
- Acronym / sponsor ID
- MS 40-1-2020
- Conditions
- Nasal Septal Deviation
- Keywords
- Caudal septal deviation, Batten graft, Septoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 8 Oct 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 clinical outcomes of septoplasty using cartilaginous batten graft in cases with caudal septal deviation as regards the relieve of nasal obstruction and aesthetic results.
Detailed description
A prospective study will be conducted over 15 patients indicated for septoplasty.
Preoperative assessment:
History
- NOSE (nasal obstruction septoplasty effectiveness score): Higher NOSE scores indicate worse nasal obstruction (range: 0-100).
- Visual analogue scale (VAS) (0-10) of nasal obstruction:For nasal obstruction
Examination:
- Anterior rhinoscopy: to confirm caudal septal deviation.
- Endoscopic nasal examination: to exclude HIT, polyp, mass and discharge.
- Basal view photograph.
- CT nose and paranasal sinuses to exclude other pathology.
Operative procedures:
- General anesthesia.
- Hemitransfixtion incision on the concave side
- The mucoperichondrial flap of the septum will be elevated
- A contralateral flap will be elevated from the caudal aspect of the cartilage
- Subperichondrial dissection into the nasal floor
- The curved portion of the septal cartilage will be harvested by excision, leaving an L-strut of dorsal and caudal cartilaginous septum
- A caudal septal batten graft created from harvested septal cartilage, then will be sutured using three or four stitches (5-0 polydioxanone sutures).
- If C-shaped caudal deviation without angulation or dislocation, cartilaginous batten graft fixed on the concave side
- If there is angulation of caudal septal end, the caudal strut will be cut by scissors at the most convex point in the caudocephalic direction. Excessive lower and upper caudal struts will be overlapped and sutured together with batten graft
- If dislocated, the septal cartilage will be separated from the anterior nasal spine (ANS) and maxillary crest for reposition. If there is an excessive cartilage portion, it will be removed and then the graft will be sutured
- The hemitransfixion incision will be closed using 5-0 Vicryl
- Internal nasal splint and anterior nasal pack will be placed in both sides
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Septoplasty Using Cartilaginous Batten Graft | Experimental | Procedure: cartilaginous batten graft septoplastyseptoplasty using cartilaginous batten graft in cases with caudal septal deviation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient presented with nasal obstruction or disfigurement due to anterocaudal septal deviation.
Key exclusion criteria (5 listed)
- Previous septal surgery
- Deformed nose, which necessitate external rhinoplasty approach.
- Other endonasal cause of nasal obstruction other than deviated nasal septum
- Bleeding disorder or systemic diseases.
- Patient who will not complete the follow up periods.
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 |
|---|---|---|
| cartilaginous batten graft septoplastyAlso: batten graft septoplastyseptoplasty using cartilaginous batten graft in cases with caudal septal deviation | Procedure or surgery | Septoplasty Using Cartilaginous Batten Graft |
Primary outcome
Nasal obstruction
Time frame: 3 months
We will use the validated Nasal obstruction septoplasty effectiveness score: (range: 0-100) Higher NOSE scores indicate worse nasal obstruction.
1 secondary outcome
Aesthetic results
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Background: PubMed 14990910Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004 Feb;130(2):157-63. doi: 10.1016/j.otohns.2003.09.016.
- Background: PubMed 24323627Chung YS, Seol JH, Choi JM, Shin DH, Kim YW, Cho JH, Kim JK. How to resolve the caudal septal deviation? Clinical outcomes after septoplasty with bony batten grafting. Laryngoscope. 2014 Aug;124(8):1771-6. doi: 10.1002/lary.24491. Epub 2013 Dec 9.
- Individual participant dataSharing planned: No
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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.
Abdelrahman A Abdelalim, MD principal investigator
Benha University
Ashraf S El-Hamshary, MD study chair
Benha University
Ibrahim S Reyad, Resident study chair
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cartilaginous batten graft septoplasty in people with Nasal Septal Deviation, run by Benha University at 1 site in Egypt.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal obstruction (time frame: 3 months). 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 NCT04579042, which also lists 2 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 6 Mar 2023.