Clinical trial NCT03891719: Correction of the Unilateral Cleft Lip Nasal Deformity With Sliding Chondrocutaneous Flap and Autologous Cartilage Graft
Official title: Correction of the Unilateral Cleft Lip Nasal Deformity Using Sliding Chondrocutaneous Flap, Caudal Septal Extension Graft and Auricular Cartilage Graft
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cleft Lip, Unilateral
Keywords: rhinoplasty
cleft lip nose
autologous cartilage graft
asian nose
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
Collaborators: name: Gia Dinh People Hospital
First posted: 2019-03-27
Enrollment: 35
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: we conduct a prospective analysis of 35 cases to assess difference between preoperative and postoperative nostril symmetry by using autologous cartilage graft and sliding chondrocutaneous flap
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of nose symmetry after secondary unilateral cleft lip rhinoplasty
timeFrame: Three years
measure: Assessment of ratio of the nose in harmony with the face after secondary unilateral cleft lip rhinoplasty
timeFrame: Three years
Secondary outcomes:
measure: Objective assessment of functional outcomes
timeFrame: Three years
measure: Subjective assessment using Rhinoplasty Outcome Evaluation Questionnaire (ROE)
timeFrame: Three years
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University of Medicine and Pharmacy at HCMC
Study officials:
affiliation: University of Medicine and Pharmacy at Ho Chi Minh City
name: KieuTho Nguyen, MD, PhD
role: STUDY_DIRECTOR
References: