Cartilaginous Batten Graft Septoplasty in Caudal Septal Deviation

Nasal Septal Deviation Clinical Trial

Official title:

Clinical Outcomes After Septoplasty Using Cartilaginous Batten Graft in The Management of The Caudal Septal Deviation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04579042
• Other study ID #: MS 40-1-2020
• Status: Completed
• Phase: N/A
• Start date: October 7, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2023
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient presented with nasal obstruction or disfigurement due to anterocaudal septal deviation.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Nasal Septal Deviation
• Nose Deformities, Acquired

Intervention

Procedure:
• cartilaginous batten graft septoplasty
septoplasty using cartilaginous batten graft in cases with caudal septal deviation

Locations

Country	Name	City	State
Egypt	Benha University Hospital, Faculty of Medicine	Banha	Qalubia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Chung 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal obstruction	We will use the validated Nasal obstruction septoplasty effectiveness score: (range: 0-100) Higher NOSE scores indicate worse nasal obstruction.	3 months
Secondary	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	6 months