Cleft Lip, UnilateralNCT03891719
Correction of the Unilateral Cleft Lip Nasal Deformity With Sliding Chondrocutaneous Flap and Autologous Cartilage Graft
A study testing Unilateral cleft lip rhinoplasty in people with Cleft Lip, Unilateral, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Cleft Lip, Unilateral
- What is being tested?
- Unilateral cleft lip rhinoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jul 2019to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who were suffered infection of facial structure
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
University of Medicine and Pharmacy at HCMC
Ho Chi Minh City, 70000
Chuong D Nguyen, Doctor of Medicine, chuongdinhnguyen@gmail.com
About this study
Official title: 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.
Read the 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)
- Conditions
- Cleft Lip, Unilateral
- Being tested
- Unilateral cleft lip rhinoplasty
- Keywords
- rhinoplasty, cleft lip nose, autologous cartilage graft, asian nose
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral cleft lip rhinoplastyProcedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Unilateral cleft lip rhinoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Three years
Secondary outcomes (2)
Objective assessment of functional outcomes
Objective measurement will be taken preoperatively and 6 months postoperatively using acoustic rhinometry
Measured: 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
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Jul 2019
- Primary completionDec 2022 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip, UnilateralStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Gia Dinh People Hospital
- Responsible party
- Principal investigator, Chuong Dinh Nguyen, MD, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- KieuTho Nguyen, MD, PhD, Study director, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891719
- Sponsor's protocol ID
- 4052/QD-DHYD
- Status last verified
- Feb 2021
- First submitted
- 24 Mar 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correction of the Unilateral Cleft Lip Nasal Deformity Using Sliding Chondrocutaneous Flap, Caudal Septal Extension Graft and Auricular Cartilage Graft
- ClinicalTrials.gov ID
- NCT03891719
- Acronym / sponsor ID
- 4052/QD-DHYD
- Conditions
- Cleft Lip, Unilateral
- Keywords
- rhinoplasty, cleft lip nose, autologous cartilage graft, asian nose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Collaborators
- Gia Dinh People Hospital
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Changes in nose symmetry | Experimental | Procedure: Unilateral cleft lip rhinoplasty- 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who were suffered infection of facial structure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Changes in nose symmetry |
Primary outcome
Assessment of nose symmetry after secondary unilateral cleft lip rhinoplasty
Time frame: Three years
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
Time frame: Three years
Measure the angles and ratios of the nose and its relation to the face (nasal projection and length, Goodle ratio, nasolabial angle)
2 secondary outcomes
Objective assessment of functional outcomes
Time frame: Three years
Subjective assessment using Rhinoplasty Outcome Evaluation Questionnaire (ROE)
Time frame: Three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KieuTho Nguyen, MD, PhD study director
University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral cleft lip rhinoplasty in people with Cleft Lip, Unilateral, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chuong Dinh Nguyen, MD (+84903638316, chuongdinhnguyen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of nose symmetry after secondary unilateral cleft lip rhinoplasty (time frame: Three years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.