Nose; AnomalyNCT03683199
Objective Assessment for Cleft Lip Nasal Deformity Correction
A study testing Rhinoplasty in people with Nose; Anomaly, run by Assiut University at 1 site in Egypt.
Trial summary
Rhinoplasty remains one of the most challenging procedures in plastic surgery, and patients with cleft lip nasal deformity pose an even greater challenge, in which biggest issue is to achieve caudal nose harmony and creation of symmetrical nostrils with patent normal nasal function Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Nose; Anomaly
- What is being tested?
- Rhinoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2018to 20 Aug 2020
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age group: > 14-16 years old females and >16-18 years old male patients.
- Patients with unilateral or bilateral cleft lip nasal deformity that isn't previously operated.
Who cannot join
- Previous rhinoplasty operated CLND cases.
- Patients who need skeletal base reconstruction.
- Syndromic cases.
- Post traumatic nasal deformity.
- Female patients less than 14 years' old and male patients less than 16 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Rhinoplasty remains one of the most challenging procedures in plastic surgery, and patients with cleft lip nasal deformity pose an even greater challenge, in which biggest issue is to achieve caudal nose harmony and creation of symmetrical nostrils with patent normal nasal function
Read the detailed description
Cleft lip and palate represent the most common birth defects affecting the head and neck region. It has been estimated, based on global birth rates that a child born with a cleft every 2.5 minutes .which is associated with varying degrees of nasal deformity grading from mild to severe inadequate function, shape and appearance of the nose. Functional impairment of the nose has been reported in 70% of cases with cleft lip. It negatively affects patients' personal and professional lives, physical activity, well-being and general quality of life.
However, historical interest in cleft lip and palate was traced to pre-Columbian artisan; the interest in the associated nasal deformities only began with rhinoplasty techniques introduced in the 19th century. That's why despite the great improvement achieved in primary repair of cleft lip and nasal deformity, the secondary cleft and nasal deformity still occur in significant number of patients, and the surgical management of the nasal deformity remains a functional and aesthetic dilemma for patients, their families and for reconstructive surgeons.
Lake of objective assessment of the initial severity and the changes introduced by growth and by surgical treatment lead to inability to optimize a treatment of cleft lip nasal deformity, hence there is no perfect surgical technique exists and surgeons must tailor approaches to individuals and evolve techniques to best serve each patient.
Although surgery can give dramatic effect, the lack of objective assessment of different surgical procedures results in decision that is based on the experience of the surgeon.
Secondary rhinoplasty is done after facial growth is completed. This is around 14 to 16 years old in female patients and 16 to 18 years old in male patients. Surgical techniques rely on well-accepted open rhinoplasty principles and are applied for unilateral or bilateral cleft nasal deformities.
Careful complete analysis followed by logical plan for each case is the key stone for success.
Multislice CT Flesh mode will be used for measuring some angles and ratios of the nose and its relation to the face. The results will be recorded at the spread sheet and the preoperative and post operative results will be compared. Other parameters can also be measured, as long as user records the measurements manually.
- Conditions
- Nose; Anomaly
- Being tested
- Rhinoplasty
- Keywords
- Secondary, Cleft, Lip, Nose, Deformity, Correction, Objective, Assessment
- Medical subject headings
- Congenital Abnormalities, Neoplasm Metastasis, Lymphoid Interstitial Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhinoplastyProcedure or surgery
The cleft lip rhinoplasty will be performed under general anesthesia.
1: 100,000 epinephrine will be infiltrated in the columellar incision and in the septum.
Open approach rhinoplasty will be used. A step ladder incision placed at the patient's columella, and continued with infra-cartilaginous incision.
The columellar skin flap along with the nasal tip skin will be dissected from the lower lateral cartilages.
Harvesting of the septal cartilage, to be used as spreader graft and columellar graft. Correction of the septal deviation.
Lengthening of the columella on the expense of the ala. Correction of the nasal tip by suturing techniques and by cartilage grafts.
| Study group | Role | What they receive |
|---|---|---|
| Cleft lip nasal deformity | Experimental | •Anthropometric evaluation of the nose (will be measured pre and post-operative) This represents the objective evaluation. It will be done by measuring the angles and ratios of the nose and its relation to the face. Common parameters will be measured from the photos (frontal, oblique, lateral and basal views) for all the patients to compare the pre-operative measures with the post-operative ones.
MSCT flesh mode will be used to measure nose related angels and ratios. It also gives idea about nasal skeleton pre-operative for proper design of the operative strategy, and it will be done post-operative for assessment and comparizon. Receives: Procedure: Rhinoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Assessment for cleft lip nasal deformity correction using MSCT with 3Dimentions in flesh mode (to compare some nasal lengths in millimeters before and after correction)
we will use Multislice CT 3D flesh mode to compare the columellar length in millimeters and inter-alar dimensions in millimeters before and after the surgical correction
Measured: three years
Objective Assessment for cleft lip nasal deformity correction using MSCT with 3Dimentions in flesh mode (to compare some nasal lengths in millimeters before and after correction)
Using MSCT with 3Dimentions in flesh mode, we will compare the angle of sepal deviation in degrees, before and after cleft nose rhinoplasty
Measured: three years
Secondary outcomes (1)
Patient's subjective assessment pre and post-operative using Rhinoplasty Outcome Evaluation questionnaire
Patient will be asked to answer six simple questions to assess his physical, mental / emotional and social life. These questions are:
How well do you like the appearance of your nose? How well are you able to breathe through your nose? How much do you feel your friend and loved ones like your nose? How much do you feel your friend and loved ones like your nose? Do you think your current nasal appearance limits your social and professional activities? How confident are you that your nasal appearance is the best can be? Patients will give answer to those questions as: not at all (0) somewhat (1) moderately (2) very much (3) completely (4) In order to reach the final result in the scale, we will add the responses from each question, and such result will be divided by 24 and multiplied by 100.
The final result will then be divided in classes, according to quartiles: zero to <25 and 25 to <50 (failure); 50 to <75 (good); and ≥75 (excellent).
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 posted25 Sep 2018
- Study start15 Oct 2018
- Primary completion20 Aug 2020
- Study completion20 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nose; AnomalyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- The total sample size will be 27 patients to study as calculated using G power version 3.1.3, in order to detect a significant difference in the mean of nasal ratios before and after surgery in the studied group (one of basic tools to measure the outcome). Assumed Effect size= 0.5, Power =0.80, Alpha error = 0.05.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafsa Gamal Muhammad bakheet, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683199
- Sponsor's protocol ID
- AUH
- Status last verified
- Aug 2020
- First submitted
- 11 Sep 2018
- Last updated
- 2 Sep 2020
- 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 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Assessment for Cleft Lip Nasal Deformity Correction
- ClinicalTrials.gov ID
- NCT03683199
- Acronym / sponsor ID
- AUH
- Conditions
- Nose; Anomaly
- Keywords
- Secondary, Cleft, Lip, Nose, Deformity, Correction, Objective, Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 25 Sep 2018 (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.
Rhinoplasty remains one of the most challenging procedures in plastic surgery, and patients with cleft lip nasal deformity pose an even greater challenge, in which biggest issue is to achieve caudal nose harmony and creation of symmetrical nostrils with patent normal nasal function
Detailed description
Cleft lip and palate represent the most common birth defects affecting the head and neck region. It has been estimated, based on global birth rates that a child born with a cleft every 2.5 minutes .which is associated with varying degrees of nasal deformity grading from mild to severe inadequate function, shape and appearance of the nose. Functional impairment of the nose has been reported in 70% of cases with cleft lip. It negatively affects patients' personal and professional lives, physical activity, well-being and general quality of life.
However, historical interest in cleft lip and palate was traced to pre-Columbian artisan; the interest in the associated nasal deformities only began with rhinoplasty techniques introduced in the 19th century. That's why despite the great improvement achieved in primary repair of cleft lip and nasal deformity, the secondary cleft and nasal deformity still occur in significant number of patients, and the surgical management of the nasal deformity remains a functional and aesthetic dilemma for patients, their families and for reconstructive surgeons.
Lake of objective assessment of the initial severity and the changes introduced by growth and by surgical treatment lead to inability to optimize a treatment of cleft lip nasal deformity, hence there is no perfect surgical technique exists and surgeons must tailor approaches to individuals and evolve techniques to best serve each patient.
Although surgery can give dramatic effect, the lack of objective assessment of different surgical procedures results in decision that is based on the experience of the surgeon.
Secondary rhinoplasty is done after facial growth is completed. This is around 14 to 16 years old in female patients and 16 to 18 years old in male patients. Surgical techniques rely on well-accepted open rhinoplasty principles and are applied for unilateral or bilateral cleft nasal deformities.
Careful complete analysis followed by logical plan for each case is the key stone for success.
Multislice CT Flesh mode will be used for measuring some angles and ratios of the nose and its relation to the face. The results will be recorded at the spread sheet and the preoperative and post operative results will be compared. Other parameters can also be measured, as long as user records the measurements manually.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The total sample size will be 27 patients to study as calculated using G power version 3.1.3, in order to detect a significant difference in the mean of nasal ratios before and after surgery in the studied group (one of basic tools to measure the outcome). Assumed Effect size= 0.5, Power =0.80, Alpha error = 0.05.
| Arm | Type | Receives |
|---|---|---|
| Cleft lip nasal deformity | Experimental | Procedure: Rhinoplasty•Anthropometric evaluation of the nose (will be measured pre and post-operative) This represents the objective evaluation. It will be done by measuring the angles and ratios of the nose and its relation to the face. Common parameters will be measured from the photos (frontal, oblique, lateral and basal views) for all the patients to compare the pre-operative measures with the post-operative ones. MSCT flesh mode will be used to measure nose related angels and ratios. It also gives idea about nasal skeleton pre-operative for proper design of the operative strategy, and it will be done post-operative for assessment and comparizon. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age group: > 14-16 years old females and >16-18 years old male patients.
- Patients with unilateral or bilateral cleft lip nasal deformity that isn't previously operated.
Key exclusion criteria (5 listed)
- Previous rhinoplasty operated CLND cases.
- Patients who need skeletal base reconstruction.
- Syndromic cases.
- Post traumatic nasal deformity.
- Female patients less than 14 years' old and male patients less than 16 years old.
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 |
|---|---|---|
| RhinoplastyThe cleft lip rhinoplasty will be performed under general anesthesia. 1: 100,000 epinephrine will be infiltrated in the columellar incision and in the septum. Open approach rhinoplasty will be used. A step ladder incision placed at the patient's columella, and continued with infra-cartilaginous incision. The columellar skin flap along with the nasal tip skin will be dissected from the lower lateral cartilages. Harvesting of the septal cartilage, to be used as spreader graft and columellar graft. Correction of the septal deviation. Lengthening of the columella on the expense of the ala. Correction of the nasal tip by suturing techniques and by cartilage grafts. | Procedure or surgery | Cleft lip nasal deformity |
Primary outcome
Objective Assessment for cleft lip nasal deformity correction using MSCT with 3Dimentions in flesh mode (to compare some nasal lengths in millimeters before and after correction)
Time frame: three years
we will use Multislice CT 3D flesh mode to compare the columellar length in millimeters and inter-alar dimensions in millimeters before and after the surgical correction
Objective Assessment for cleft lip nasal deformity correction using MSCT with 3Dimentions in flesh mode (to compare some nasal lengths in millimeters before and after correction)
Time frame: three years
Using MSCT with 3Dimentions in flesh mode, we will compare the angle of sepal deviation in degrees, before and after cleft nose rhinoplasty
1 secondary outcome
Patient's subjective assessment pre and post-operative using Rhinoplasty Outcome Evaluation questionnaire
Time frame: three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhinoplasty in people with Nose; Anomaly, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 2 Sep 2020. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Assessment for cleft lip nasal deformity correction using MSCT with 3Dimentions in flesh mode (to compare some nasal lengths in millimeters before and after correction) (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 2 Sep 2020; AzTrials last refreshed its copy on 26 Oct 2026.