Correction of the Unilateral Cleft Lip Nasal Deformity With Sliding Chondrocutaneous Flap and Autologous Cartilage Graft

Not Applicable

• Conditions: Cleft Lip, Unilateral
• Interventions: Procedure: Unilateral cleft lip rhinoplasty

• Registration Number: NCT03891719
• Lead Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

Brief Summary

Cleft lip and cleft palate are the most common birth defects of craniofacial development. The surgical repair of this deformity requires comprehensive management plans and well cooperating interdisciplinary cleft teams. Secondary cleft rhinoplasty remains one of the most challenging procedures and aims for restoring nostril symmetry, enhancing nasal function, and improvement of aesthetic outcomes.

Detailed Description

For the majority of cleft patients, surgeons usually delay secondary rhinoplasty to ages 14 to 16 years for females and 16 to 18 years for males until after completion of nasal growth Unilateral secondary cleft nasal deformity results from hypoplastic nasal tissue, asymmetric growth due to impaired growth, and surgical scarring. The most common deformities include caudal septal deviation, retrodisplacement and under-projection of dome, lateral slumping of the medial crus of the lower lateral cartilage, alar-columellar web, insufficiency of vestibular skin and deficiency of nasal floor. Moreover, these deformities have negative effect on human well-being and quality of life.

Despite the opinions on how to address the problems, it seems clear that repositioning and reshaping of the cleft-side cartilages is necessary for restoring form and function. In general, in order to there are two basic approaches: those techniques that move the cleft-side lower lateral cartilage from medial to lateral, and those that move the lower lateral cartilage from lateral to medial. In an effort to correct the vestibular lining deficiency, easily be adapted to combine Tajima's reverse-U incisions for treatment of alar hooding, need for other structural grafts, sliding chondrocutaneous flap offers many advantages. However, in order to improve nasal tip position or columella shape through modification of either the anterior septal and/or posterior septal angle position and to act as the fundamental attachment for sliding lower lateral cartilage, Caudal septal extension and Columellar strut graft play an important role to stabilize the nasal tip.

Besides, with the aim of making it harmonize better with other facial features, dorsal augmentation is needed for improving the shape of the nose. Selecting the optimal material continues to be a challenge. For most surgeons, an autogenous cartilage graft is the first choice in rhinoplasty because of its resistance to infection and resorption.

We assess the functional and aesthetic outcomes based on three criteria:

1. Change in nose symmetry and nasal height (Preoperative and postoperative photographic analyses)

2. Change in functional outcomes through subjective and objective measurement (Questionaire and acoustic rhinometry)

3. Change in Quality of life (Rhinoplasty Outcome Evaluation Questionaire)

Study Timeline

• Study First Submitted: 2019-03-24
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-27
• Study Start: 2019-07-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-10
• Primary Completion: 2022-12
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Patients with unilateral cleft lip deformity that was previously performed primary cheiloplasty
• No other craniofacial malformation
• Age: > 14-16 years old in female, >16-18 years old in male
• Patients with follow-up period of at least 6 months.

Exclusion Criteria

• Patients who were suffered infection of facial structure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Changes in nose symmetry	Unilateral cleft lip rhinoplasty	- Direct anthropometric assessment (frontal, oblique, lateral and basal views) and three- dimensional observations of the nose preoperatively and postoperatively in order to evaluate the nostril symmetry, the angles, ratios of the nose and its relation to the face.

Primary Outcome Measures

Name	Time	Method
Assessment of ratio of the nose in harmony with the face after secondary unilateral cleft lip rhinoplasty	Three years	Measure the angles and ratios of the nose and its relation to the face (nasal projection and length, Goodle ratio, nasolabial angle)
Assessment of nose symmetry after secondary unilateral cleft lip rhinoplasty	Three years	Use computer software program to compare the nostril symmetry preoperatively and postoperatively: columella height (mm), columella width (mm), nostril height (mm), nostril width (mm), nose base (mm)

Secondary Outcome Measures

Name	Time	Method
Subjective assessment using Rhinoplasty Outcome Evaluation Questionnaire (ROE)	Three years	Patients will be asked 6 questions from ROE questionnaire preoperatively and postoperatively to assess mental / emotional and quality of life
Objective assessment of functional outcomes	Three years	Objective measurement will be taken preoperatively and 6 months postoperatively using acoustic rhinometry

Trial Locations

Locations (1)

University of Medicine and Pharmacy at HCMC; 🇻🇳 Ho Chi Minh City, Vietnam