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Completed

NCT Number: NCT04579042

Cartilaginous Batten Graft Septoplasty in 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.

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Key information

Conditions

Nasal Septal Deviation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University Hospital, Faculty of Medicine

Banhā, Qalyubia Governorate, 13512, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cartilaginous batten graft septoplasty

Procedure

septoplasty using cartilaginous batten graft in cases with caudal septal deviation

Other names: batten graft septoplasty

Primary outcomes

  1. 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.

Secondary outcomes

  1. Aesthetic results

    Time frame: 6 months

    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

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 8, 2020
Registry last updated
Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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