Outcomes Assessment of Septal Extension Graft Versus Columellar Strut Graft in Rhinoplasty.

April 27, 2025 updated by: Hossam Aldein Samir Abd Elazeem Mohammed, Assiut University

Nose is an important aesthetic landmark with its length, width, shape, and position in the middle of the face. Rhinoplasty is now one of the most common rhinological procedures with both functional and aesthetic aspects. Tip plasty is considered the core of rhinoplasty. The interaction among lower lateral cartilages, septal cartilage, adjacent soft tissues, tissue dynamics, and surgical techniques determines the nasal tips projection, rotation, and overall shape. Various graft sources and types were used for tip support in rhinoplasty such as columellar struts, septal extensions, and cap grafts.

The columellar strut graft, first introduced in 1932, has became a widely adopted technique. Typically a cartilage graft is positioned between the medial crura to provide support and stability to the nasal tip. Recent studies reported some drawbacks of columellar strut such as widening the columella and resorption or displacement of the graft due to their lack of attachment to the caudal septum. Septal extension grafts extend from the caudal edge of the nasal septum into the lower lateral cartilages, these grafts offer crucial structural support to the nasal tip. Despite of their the wide use of columellar strut and septal extention graft, limited studies compared their results.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult patient (more than 18 years).
  2. Patients with any type of tip deformaties.
  3. Patients fit for surgery.

Exclusion Criteria:

  1. Patients with history of previous nasal surgery.
  2. Pregnant patients.
  3. Patients with chronic diseases affecting wound healing e.g. DM and blood diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Septal extension graft will be used. The triangle-shaped cartilage graft prepared from the septal cartilage is placed into one or bothsides of the caudal septum reciprocally according to its structure and curvature and sutured with horizontal mattress sutures. After graft stabilization, two insulin needles are passed through the medial crura and the graft to determine its level of placement. After the rotation and nasal projection are adjusted, the medial crura are sutured to the septal extension grafts.
Procedure: Septal extension graft
Septal extension graft will be used. The triangle-shaped cartilage graft prepared from the septal cartilage is placed into one or bothsides of the caudal septum reciprocally according to its structure and curvature and sutured with horizontal mattress sutures. After graft stabilization, two insulin needles are passed through the medial crura and the graft to determine its level of placement. After the rotation and nasal projection are adjusted, the medial crura are sutured to the septal graft.
Active Comparator: Group 2
Columellar strut graft will be used. A strut graft 10-12 mm long is placed into a web created between the two medial crura and stabilized by sutures placed between the graft and medial crura.
Procedure: Columellar strut
Columellar strut graft will be used. A strut graft 1012 mm long is placed into a web created between the two medial crura and stabilized by sutures placed between the graft and medial crura.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tip projection and rotation
Time Frame: These values will be evaluated before surgical intervention and 6 months after the surgery

Two factors will be assessed to compare the changes of tip projection and rotation in each group: the ratio of nasal projection to nasal length and the columellar-labial angle values.

The program Rhinobase developed by Apaydin et Al. will be used for photographic analysis to calculate the the ratio of nasal projection to nasal length and the columella labial angle values. This software allowed for consistent and objective measurements that were independent of the individual performing the analysis, minimizing variability. These values will be evaluated before surgical intervention and 6 months after the surgery.
These values will be evaluated before surgical intervention and 6 months after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: Before and 6 months after the surgery.

Patient satisfaction will be assessed using an arabic version of validated rhinoplasty outcome evaluation (ROE) questionnaire six months after the surgery. The questionnaire is consist of six questions and each question is scored on 0-4 scale:

0: worest possible outcome. 4:best possible outcome. The score from the six questions are summed up to give the total score. The total is then divided by 24 (the maximum score) and multiplied by 100 to get a percentage.
Before and 6 months after the surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

April 27, 2025

First Posted (Actual)

May 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

April 27, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • septal extension graf

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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