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

Primary Purpose

Cleft Lip, Unilateral

Status
Recruiting
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Unilateral cleft lip rhinoplasty
Sponsored by
University of Medicine and Pharmacy at Ho Chi Minh City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Lip, Unilateral focused on measuring rhinoplasty, cleft lip nose, autologous cartilage graft, asian nose

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Medicine and Pharmacy at HCMCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Changes in nose symmetry

Arm Description

- 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.

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

Objective assessment of functional outcomes
Objective measurement will be taken preoperatively and 6 months postoperatively using acoustic rhinometry
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

Full Information

First Posted
March 24, 2019
Last Updated
February 8, 2021
Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Collaborators
Gia Dinh People Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03891719
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Collaborators
Gia Dinh People Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: Change in nose symmetry and nasal height (Preoperative and postoperative photographic analyses) Change in functional outcomes through subjective and objective measurement (Questionaire and acoustic rhinometry) Change in Quality of life (Rhinoplasty Outcome Evaluation Questionaire)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip, Unilateral
Keywords
rhinoplasty, cleft lip nose, autologous cartilage graft, asian nose

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Changes in nose symmetry
Arm Type
Experimental
Arm Description
- 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.
Intervention Type
Procedure
Intervention Name(s)
Unilateral cleft lip rhinoplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of nose symmetry after secondary unilateral cleft lip rhinoplasty
Description
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)
Time Frame
Three years
Title
Assessment of ratio of the nose in harmony with the face after secondary unilateral cleft lip rhinoplasty
Description
Measure the angles and ratios of the nose and its relation to the face (nasal projection and length, Goodle ratio, nasolabial angle)
Time Frame
Three years
Secondary Outcome Measure Information:
Title
Objective assessment of functional outcomes
Description
Objective measurement will be taken preoperatively and 6 months postoperatively using acoustic rhinometry
Time Frame
Three years
Title
Subjective assessment using Rhinoplasty Outcome Evaluation Questionnaire (ROE)
Description
Patients will be asked 6 questions from ROE questionnaire preoperatively and postoperatively to assess mental / emotional and quality of life
Time Frame
Three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chuong Dinh Nguyen, MD
Phone
+84903638316
Email
chuongdinhnguyen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KieuTho Nguyen, MD, PhD
Organizational Affiliation
University of Medicine and Pharmacy at Ho Chi Minh City
Official's Role
Study Director
Facility Information:
Facility Name
University of Medicine and Pharmacy at HCMC
City
Ho Chi Minh City
ZIP/Postal Code
70000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuong D Nguyen, Doctor of Medicine
Email
chuongdinhnguyen@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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