Cartilaginous Batten Graft Septoplasty in Caudal Septal Deviation

March 3, 2023 updated by: Abdelrahman Ahmed Abdelalim, Benha University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Qalubia
      • Banhā, Qalubia, Egypt, 13512
        • Benha University Hospital, Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Septoplasty Using Cartilaginous Batten Graft
septoplasty using cartilaginous batten graft in cases with caudal septal deviation
Procedure: cartilaginous batten graft septoplasty
septoplasty using cartilaginous batten graft in cases with caudal septal deviation
Other Names:
  • batten graft septoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Study Chair: Ashraf S El-Hamshary, MD, benha faculty of medicine
  • Study Chair: Ibrahim S Reyad, Resident, Benha university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2020

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

October 1, 2020

First Submitted That Met QC Criteria

October 7, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS 40-1-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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