NCT04579042

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

October 7, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

2.2 years

First QC Date

October 1, 2020

Last Update Submit

March 3, 2023

Conditions

Nasal Septal Deviation

Keywords

Caudal septal deviationBatten graftSeptoplasty

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Aesthetic results

    6 months

Study Arms (1)

Septoplasty Using Cartilaginous Batten Graft

EXPERIMENTAL

septoplasty using cartilaginous batten graft in cases with caudal septal deviation

Procedure: cartilaginous batten graft septoplasty

Interventions

cartilaginous batten graft septoplastyPROCEDURE

septoplasty using cartilaginous batten graft in cases with caudal septal deviation

Also known as: batten graft septoplasty
Septoplasty Using Cartilaginous Batten Graft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University Hospital, Faculty of Medicine

Banhā, Qalyubia Governorate, 13512, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 14990910BACKGROUND

  • 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.

    PMID: 24323627BACKGROUND

Study Officials

  • Abdelrahman A Abdelalim, MD

    Benha University

    PRINCIPAL INVESTIGATOR

  • Ashraf S El-Hamshary, MD

    Benha University

    STUDY CHAIR

  • Ibrahim S Reyad, Resident

    Benha University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Otorhinolaryngology

Study Record Dates

First Submitted

October 1, 2020

First Posted

October 8, 2020

Study Start

October 7, 2020

Primary Completion

January 1, 2023

Study Completion

March 1, 2023

Last Updated

March 6, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)