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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-23

Study Completion Date

2025-01-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Objective Assessment for Cleft Lip Nasal Deformity Correction

NCT03683199

Nose; Anomaly

COMPLETED NA

Nasolabial Soft Tissue Esthetics and Maxillary Changes in Unilateral Cleft Lip and Palate Using PreSurgical Infant Orthopedics With Different Approaches

NCT05940389

Unilateral Cleft Lip Nasoalveolar Molding

UNKNOWN NA

Single Stage Versus Multiple Staged Repair of Nasal & Alveolar Deformities in Patients With Cleft Lip and Palate

NCT06510881

Cleft Lip and Palate Rhinoplasty

RECRUITING NA

Indications and Evaluation of Microfat Grafting in Cleft Lip Nasal Deformities

NCT05830006

Cleft Lip and Nose

NOT_YET_RECRUITING NA

Repair of Oronasal Fistula Using Interpositional Buccal Pad of Fat as a Free Graft in a Cleft Palate Patient

NCT06807450

Cleft Palate

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Cutting in 2009 described a technique for tip cleft rhinoplasty which combines an open rhinoplasty with the Dibbell and Tajima techniques (Flores, Sailon et al. 2009). Ayeroff, Volpicelli et al. described the component restoration approach for intermediate cleft rhinoplasty that addresses the three anatomical disturbances of the cleft nasal tip: lower lateral cartilage malpositioning, lower lateral cartilage hypoplasia, and nasal lining deficiency(Ayeroff, Volpicelli et al. 2019). Ohara, Nakajima et al. described the use of the subcutaneous flap technique to address the cleft bulbous nasal tip and define the alar groove through an open rhinoplasty approach (Ohara, Nakajima et al. 2009).

There are conflicting views regarding the use of cartilage grafts in intermediate cleft rhinoplasty. However, recent studies approved their use during the 5- to 13-year age period and found that it was effective in aesthetic and functional outcomes, with a low-risk profile (Ozaki, Chaffoo et al. 2006, Lu, Yao et al. 2017, Zhang, Bai et al. 2018, Pagan, Sterling et al. 2021).

The large number of techniques in the literature to address this challenge is a testament to both the complexity of the task and the limitations of our ability to provide dependable surgical solutions (Hoshal, Solis et al. 2020). Successful surgical correction is often surgeon-dependent and often based on training and experience (Hoshal, Solis et al. 2020). As Dibbell observed in 1982, "Anytime there are many differing attacks on a surgical problem area, the sophisticated practitioner will conclude that none of these approaches are satisfactory" (Dibbell 1982). To date, there is no consensus regarding universal guidelines or the ideal techniques for the management of cleft nasal deformities (Olds and Sykes 2022).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Unilateral Cleft Lip

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Unilateral Cleft Lip Patients

Study is intermediate cleft rhinoplasty that will be performed in the patients with nasal deformities after repair of unilateral cleft lip congenital anomaly

Group Type OTHER

intermediate cleft rhinoplasty

Intervention Type PROCEDURE

intermediate cleft rhinoplasty using open approach and combined techniques of Tajima, Dibbell and Potter's Rhinoplasty

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.