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

Correction of the Unilateral Cleft Lip Nasal Deformity Using Sliding Chondrocutaneous Flap, Caudal Septal Extension Graft and Auricular Cartilage Graft

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.

Study Overview

• Status: Recruiting
• Conditions: Cleft Lip, Unilateral
• Intervention / Treatment: Procedure: Unilateral cleft lip rhinoplasty

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 Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chuong Dinh Nguyen, MD; Phone Number: +84903638316; Email: chuongdinhnguyen@gmail.com

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam, 70000
    • Recruiting
    • University of Medicine and Pharmacy at HCMC
    • Contact: Chuong D Nguyen, Doctor of Medicine; Email: chuongdinhnguyen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Changes in nose symmetry; - 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.

Procedure: Unilateral cleft lip rhinoplasty; Perform marking with methylene blue tattoo marks; Inject Local anesthetic solution with epinephrine; Harvest auricular cartilage; Make the incisions parallel the lip scar, extende into the marginal incision and encompass any alar webbing. The incisions outline the entirety of the lower lateral cartilage and create sliding chondrocutaneous flap. This flap combines with reverse U incision.; Harvest septal bony cartilaginous unit for grafting the caudal septum and suspend the medial crural cartilages; Create dome symmetry at the cartilage level and reconstruct nasal tip with other grafts (shield-type tip graft, cap graft, alar batten graft); Dorsal augmentation; Lip reconstruction and alar base repositioning.; Closure and repair vestibular deficiency with the reverse-U component of the chondrocutaneous flap at the alar rim.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of nose symmetry after secondary unilateral cleft lip rhinoplasty	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)	Three years
Assessment of ratio of the nose in harmony with the face after secondary unilateral cleft lip rhinoplasty	Measure the angles and ratios of the nose and its relation to the face (nasal projection and length, Goodle ratio, nasolabial angle)	Three years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
• Collaborators: Gia Dinh People Hospital
• Investigators: Study Director: KieuTho Nguyen, MD, PhD, University of Medicine and Pharmacy at Ho Chi Minh City

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: March 24, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 27, 2019

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: rhinoplasty; cleft lip nose; autologous cartilage graft; asian nose
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: 4052/QD-DHYD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No