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

Not Applicable

Recruiting

• Conditions: Rhinoplasty
• Interventions: Procedure: comparison of septal advancement flap effect on nasal tip in primary rhinoplasty to columellar strut technique

• Registration Number: NCT06370455
• Lead Sponsor: Tanta University

Brief 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

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 Timeline

• Study Start: 2024-01-23
• Status Verified: 2024-04
• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-17
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-06-23
• Study Completion: 2025-08-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Droopy nasal tip

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Columellar strut group	comparison of septal advancement flap effect on nasal tip in primary rhinoplasty to columellar strut technique	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.
Septal advancement flap group	comparison of septal advancement flap effect on nasal tip in primary rhinoplasty to columellar strut technique	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.

Primary Outcome Measures

Name	Time	Method
measuring the degree of tip projection and rotation preoperative and postoperative	one month and three months	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.
subjective assessment using Rhinoplasty Outcome Evaluation Questionnaire	preoperative and one month postoperative	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.

Trial Locations

Locations (1)

Otorhinolaryngology department -Tanta University Hospitals; 🇪🇬 Tanta, Egypt