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

NCT03891719 | Unknown DMC

• 1 other identifier: 4052/QD-DHYD
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft Lip, Unilateral

Keywords

rhinoplasty; cleft lip nose; autologous cartilage graft; asian nose

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Objective assessment of functional outcomes

  Three years

• Subjective assessment using Rhinoplasty Outcome Evaluation Questionnaire (ROE)

  Three years

Study Arms (1)

Changes in nose symmetry

EXPERIMENTAL

\- 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

Interventions

Unilateral cleft lip rhinoplasty 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.

Changes in nose symmetry

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Patients who were suffered infection of facial structure

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead
• Gia Dinh People Hospital: collaborator

Study Sites (1)

University of Medicine and Pharmacy at HCMC

Ho Chi Minh City, 70000, Vietnam

RECRUITING

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• KieuTho Nguyen, MD, PhD

  University of Medicine and Pharmacy at Ho Chi Minh City

  STUDY DIRECTOR

Central Study Contacts

Chuong Dinh Nguyen, MD

CONTACT

+84903638316; chuongdinhnguyen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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

Study Record Dates

• First Submitted: March 24, 2019
• First Posted: March 27, 2019
• Study Start: July 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: November 1, 2023
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

VN (1)