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临床试验/NCT06958575
NCT06958575尚未招募不适用

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

Assiut University0 个研究点目标入组 60 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Tip projection and rotation

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

Group 1

Experimental

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.

干预措施: Septal extension graft (Procedure)

Group 2

Active Comparator

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.

干预措施: Columellar strut (Procedure)

结局指标

主要结局

Tip projection and rotation

时间窗: 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.

次要结局

  • Patient satisfaction(Before and 6 months after the surgery.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hossam Aldein Samir Abd Elazeem Mohammed

Dr

Assiut University

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