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

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

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

Study Overview

• Status: Recruiting
• Conditions: Rhinoplasty
• Intervention / Treatment: Procedure: comparison of septal advancement flap effect on nasal tip in primary rhinoplasty to columellar strut technique

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Elsaied Allam, master; Phone Number: +2 01011678121; Email: mohamed.3llam96@gmail.com

Study Locations

• Egypt
  • Tanta, Egypt
    • Recruiting
    • Otorhinolaryngology department -Tanta University Hospitals
    • Contact: Mohamed Elsayed Elkady, MD; Phone Number: +2 01004582738

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Depressed nasal tip

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group (A); Fifteen patients will undergo septal advancement flap technique The mucoperichondrial flaps are elevated over the cartilaginous septum and the caudal perpendicular plate of the ethmoid. investigator will take L shape flap of the dorsal and anterior end of cartilaginous septum then advance them and suture the flap at certain points so can support the nasal tip.	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.
Active Comparator: Group (B); fifteen patients will undergo columellar strut technique. investigator will extract columellar strut from septal cartilage then insert it between the two medial crura n the intercrural space and sutured to nasal spine so can support nasal tip.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Tanta University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2024
• Primary Completion (Estimated): February 23, 2025
• Study Completion (Estimated): April 20, 2025

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Estimated): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 36264MS429/11/23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No