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

NCT ID: NCT03891719

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2023-11-30

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)

Conditions

Cleft Lip, Unilateral

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Unilateral cleft lip rhinoplasty

Intervention Type: PROCEDURE

• 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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gia Dinh People Hospital

OTHER

Sponsor Role: collaborator

University of Medicine and Pharmacy at Ho Chi Minh City

OTHER

Sponsor Role: lead

Responsible Party

Chuong Dinh Nguyen, MD

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

KieuTho Nguyen, MD, PhD

Role: STUDY_DIRECTOR

University of Medicine and Pharmacy at Ho Chi Minh City

Locations

University of Medicine and Pharmacy at HCMC

Ho Chi Minh City, , Vietnam

Site Status: RECRUITING

Countries

Vietnam

Central Contacts

Chuong Dinh Nguyen, MD

Role: CONTACT

chuongdinhnguyen@gmail.com

+84903638316

Facility Contacts

Chuong D Nguyen, Doctor of Medicine

Role: primary

chuongdinhnguyen@gmail.com

Other Identifiers

4052/QD-DHYD

Identifier Type: -

Identifier Source: org_study_id