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NCT Number: NCT06958575

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Septal extension graft

Procedure

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.

Columellar strut

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hossam Aldein Mohammed

CONTACT

[email protected]

+201019858519

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 6, 2025
Registry last updated
May 6, 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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