Cartilaginous Batten Graft Septoplasty in Caudal Septal Deviation

NCT ID: NCT04579042

Last Updated: 2023-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-07
• Study Completion Date: 2023-03-01

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

Conditions

Nasal Septal Deviation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Septoplasty Using Cartilaginous Batten Graft

septoplasty using cartilaginous batten graft in cases with caudal septal deviation

Group Type: EXPERIMENTAL

cartilaginous batten graft septoplasty

Intervention Type: PROCEDURE

septoplasty using cartilaginous batten graft in cases with caudal septal deviation

Interventions

cartilaginous batten graft septoplasty

septoplasty using cartilaginous batten graft in cases with caudal septal deviation

Intervention Type: PROCEDURE

Other Intervention Names

batten graft septoplasty

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Abdelrahman Ahmed Abdelalim

Lecturer of Otorhinolaryngology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdelrahman A Abdelalim, MD

Role: PRINCIPAL_INVESTIGATOR

Benha University

Ashraf S El-Hamshary, MD

Role: STUDY_CHAIR

Benha University

Ibrahim S Reyad, Resident

Role: STUDY_CHAIR

Benha University

Locations

Benha University Hospital, Faculty of Medicine

Banhā, Qalyubia Governorate, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 14990910 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24323627 (View on PubMed)

Other Identifiers

MS 40-1-2020

Identifier Type: -

Identifier Source: org_study_id