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

NCT06370455 | Completed DMC

• 1 other identifier: 36264MS429/11/23
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Rhinoplasty

Outcome Measures

Primary Outcomes (2)

• 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

• 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.

  Preoperative,one month and six months postoperative

Study Arms (2)

Septal advancement flap group

ACTIVE COMPARATOR

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

Columellar strut group

ACTIVE COMPARATOR

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

Interventions

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.

Columellar strut group; Septal advancement flap group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Droopy nasal tip

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Otorhinolaryngology department -Tanta University Hospitals

Tanta, Egypt

Location

Related 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.

  PMID: 37036815 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: January 23, 2024
• Primary Completion: August 23, 2025
• Study Completion: October 25, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-08

Locations

EG (1)