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Completed

NCT Number: NCT06370455

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Otorhinolaryngology department -Tanta University Hospitals

Tanta, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Droopy nasal tip

Exclusion criteria

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

Treatment and study plan

comparison of septal advancement flap effect on nasal tip in primary rhinoplasty to columellar strut technique

Procedure

All patients will be operated on under general anesthesia through an open rhinoplasty then will undergo 2 different procedures according to each group.

Primary outcomes

  1. subjective assessment using Rhinoplasty Outcome Evaluation Questionnaire

    Time frame: 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.

  2. measuring the degree of tip projection and rotation preoperative and postoperative

    Time frame: Preoperative,one month and six months 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 17, 2024
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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