Comparison of Septal Advancement Flap and Columellar Strut Effect on Nasal Tip

Rhinoplasty Clinical Trial

Official title:

Comparison of Septal Advancement Flap and Columellar Strut in Preserving, Restructuring, and Reshaping the Nasal Tip Contour in Rhinoplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06370455
• Other study ID #: 36264MS429/11/23
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2024
• Est. completion date: April 20, 2025

Study information

• Verified date: April 2024
• Source: Tanta University
• Contact: Mohamed Elsaied Allam, master
• Phone: 01011678121
• Email: mohamed.3llam96[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study to compare and evaluate the effect of septal advancement flap in preserving and reshaping the nasal tip with columellar strut graft

Description:

The ideal tip support graft should support the exact position over time, avoid stiffness of a natural soft structure of the tip, be easily harvested typically septal cartilage, facilitate surgeon control of rotation and projection. To address these desirable features the septal advancement flap (SAF) was developed. The septal advancement flap (SAF) is a rotational advancement flap of the superior and caudal aspects of the cartilaginous septum that enables the surgeon to create stable and accurate tip shape and position. This is a technically easy and reliable flap mainly applicable to primary rhinoplasty. so investigator compare between this new technique and old one like columellar strut to know the effect on nasal tip

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 20, 2025
• Est. primary completion date: February 23, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Droopy nasal tip

Exclusion Criteria:

• severely deficient cartilaginous septum.
• previous nasal operations, history of cleft lip or cleft palate.
• bleeding disorders.

Related Conditions & MeSH terms

• Rhinoplasty

Intervention

Procedure:
• comparison of septal advancement flap effect on nasal tip in primary rhinoplasty to columellar strut technique
All patients will be operated on under general anesthesia through an open rhinoplasty then will undergo 2 different procedures according to each group.

Locations

Country	Name	City	State
Egypt	Otorhinolaryngology department -Tanta University Hospitals	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Goncalves Ferreira M. Septal Advancement Flap: Preserving, Restructuring, and Reshaping the Nasal Tip Contour with a Novel Flap. Facial Plast Surg Aesthet Med. 2023 Jul-Aug;25(4):279-284. doi: 10.1089/fpsam.2023.0060. Epub 2023 Apr 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	subjective assessment using Rhinoplasty Outcome Evaluation Questionnaire	Assessment of patient satisfaction with primary septorhinoplasty using the Arabic Rhinoplasty Outcome Evaluation (ROE) Questionnaire and comparing the preoperative with postoperative scores. The ROE comprises 6 questions. Each answer is scored on a scale from 0-4, where 0 corresponds to the "most negative answer" and 4 corresponds to the "most positive answer." As a result, the total score can range from 0 to 24.; To make the results easier to understand, the total score can be divided by 24 and multiplied by 100 to obtain a value between 0% and 100%, where higher values represent greater patient satisfaction.	preoperative and one month postoperative
Primary	measuring the degree of tip projection and rotation preoperative and postoperative	Objective assessment by measuring the degree of tip projection and rotation preoperative and postoperative by using the angle between the columella and the line intersecting the junction between the columella and the upper lip and the vermilion border of the upper lip for measuring the nasolabial angle.	one month and three months