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临床试验/NCT06127953
NCT06127953招募中不适用

Intermediate Cleft Rhinoplasty in Unilateral Cleft Lip Patients: Approaches and Outcomes

Mohamed Elsayed Abdelmonem2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年10月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
2
主要终点
measurements of nostril apex height on the cleft lip side.

研究概览

简要总结

This is a prospective study of 20 patients with unilateral cleft lip nasal deformity. The technique to be performed is open approach intermediate rhinoplasty using a hybrid technique combining Potter, Dibbell, and Tajima methods as needed (Potter 1954, Tajima and Maruyama 1977, Dibbell 1982). Lip revision will be performed with the intermediate cleft rhinoplasty according to the lip deformity if needed.

Aim of the work is To propose an algorithmic approach for management of unilateral cleft lip nasal deformity using hybrid techniques of intermediate cleft rhinoplasty and to assess the aesthetic and functional outcomes.

All the regulations of the ethical committee of the faculty of medicine in Sohag University will be followed. Each patient will have a private file with a non-disclosure policy at data presentation where all presented data do not contain any personal information specifying the identity of any of the patients. Informed written consent will be taken from all patients in the study.

Regarding patients' assessment, the following items will be fulfilled:

Full medical and operative history. Complete physical examination. Nasal examination, including nasal analysis, anterior rhinoscopy, Cottle maneuver, modified Cottle maneuver, and possibly endoscopic examination to fully assess any functional problems.

Routine laboratory investigations Standard preoperative photographs (frontal, lateral and basal).

Surgery follow up will be at 1 week ,1 month, 3 months, 6 months and 1 year and postoperative photographs will be taken.

详细描述

Cleft lip and palate is the most common congenital craniofacial abnormality (Jeong, Lee et al. 2012, Yue, Piao et al. 2023). Cleft nasal deformity is the most prominent aesthetic problem in the growing cleft patient after lip repair (Park, Koo et al. 2022). Correction of the residual cleft lip nasal deformity remains a complex and difficult to manage challenge as nasal asymmetry increases with the growth and development of the affected child in addition to the scarring from previous surgeries of the lip and nose (Ayeroff, Volpicelli et al. 2019). The cleft nasal deformity affects all layers of the nose including the bony platform, the inner lining, the cartilaginous infrastructure, and the external skin (Olds and Sykes 2022). The severity of nasal deformity is dependent upon the degree of the original cleft lip abnormality (Gary and Sykes 2016).

There has been a debate for long time regarding the timing of cleft rhinoplasty and there has been a trend to perform it after the age of full maturity. The rationale behind this belief was to avoid interference with nasal growth, however many studies have disproved this traditional idea (Pagan, Sterling et al. 2021) and even in Millard's classic paper, he pointed out that a minor aesthetic correction during childhood is sometimes required (Millard 1964). Cleft rhinoplasties are divided into 3 stages: primary, performed within the first year of life; intermediate, performed prior to completion of facial growth; and definitive, which occurs after skeletal and dental maturity (Ayeroff, Volpicelli et al. 2019).

Intermediate cleft rhinoplasty is defined as any nasal surgery performed between the time of initial cleft lip repair and the time at which the patient reaches facial skeletal maturity (around 15 to 17 years of age in females and in male patients at approximately 16 to 18 years of age) (Gary and Sykes 2016). Intermediate rhinoplasty is indicated in case of functional compromise (nasal obstruction and sleep apnea) as in severe septal deviation and severe alar deformities and in situations of child and parent wishes due to psychological distress from their peers in school age. Some studies have shown that children with orofacial cleft suffer the highest incidence of depression, anxiety, and negative peer relationships around the ages 8 to 10 years (Hoshal, Solis et al. 2020, Olds and Sykes 2022, Park, Koo et al. 2022).

One of the earliest attempts to correct the nasal tip deformity was in 1932 when Gillies and Kilner described the "alar shift" technique, allowing for the advancement of the cleft side columella towards the tip (Wilkie 1969). In 1938, McIndoe was the first surgeon to reposition and fix the cartilage of the cleft side (McIndoe 1938), but Potter in 1954 added the concept of not only repositioning the lower lateral cartilage medially but also the lateral release via an open nasal approach(Potter 1954, Rousso 2015).

In 1964, Millard introduced the concept of additional support using auricular cartilage grafts at 5 years of age with cleft tip revisions (Millard 1964). Tajima and Maruyama in 1977 pointed out that the overhanging alar web is one of the most visible stigmata of cleft noses and this excess skin will result in cartilage malposition and redundancy (Tajima and Maruyama 1977, Nicksic, Pfaff et al. 2018). In 1982, Dibbell described a procedure to address the alar web by rotating and advancing the nostril medially and superiorly in addition to fixation of cleft lower lateral cartilage (Dibbell 1982). Blackwell in 1985 focused on both cartilage reposition and utility of additional support (Blackwell, Parry et al. 1985, Nicksic, Pfaff et al. 2018).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Year 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients with repaired unilateral cleft lip with or without cleft palate with residual nasal deformity.
  • Patients aged 1 to 13 years.
  • Patients who underwent or did not undergo primary rhinoplasty during the cleft lip repair.

排除标准

  • Patients with bilateral cleft lip.
  • Patients who underwent lip/nose revision.
  • Patients or parents' refusal to participate in the study.

结局指标

主要结局

measurements of nostril apex height on the cleft lip side.

时间窗: 1 week then 1, 3, 6 and 12 months post operative date

Preoperative and postoperative measurements of nostril apex height on the cleft lip side will be compared to determine the effects of surgery on the nasal form.

次要结局

  • The visual effect of the rhinoplasty.(1 week then 1, 3, 6 and 12 months post operative date)

研究者

发起方
Mohamed Elsayed Abdelmonem
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohamed Elsayed Abdelmonem

Plastic surgery assistant lecturer

Sohag University

研究点 (2)

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