Clinical trial NCT04579042: Cartilaginous Batten Graft Septoplasty in Caudal Septal Deviation
Official title: Clinical Outcomes After Septoplasty Using Cartilaginous Batten Graft in The Management of The Caudal Septal Deviation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Septal Deviation
Keywords: Caudal septal deviation
Batten graft
Septoplasty
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Nasal obstruction
timeFrame: 3 months
Secondary outcomes:
measure: Aesthetic results
timeFrame: 6 months
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University Hospital, Faculty of Medicine
state: Qalubia
Study officials:
affiliation: Benha University
name: Abdelrahman A Abdelalim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Benha University
name: Ashraf S El-Hamshary, MD
role: STUDY_CHAIR
affiliation: Benha University
name: Ibrahim S Reyad, Resident
role: STUDY_CHAIR
References:
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.
citation: 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.