Clinical trial NCT03683199: Objective Assessment for Cleft Lip Nasal Deformity Correction
Official title: Objective Assessment for Cleft Lip Nasal Deformity Correction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nose; Anomaly
Keywords: Secondary
Cleft
Lip
Nose
Deformity
Correction
Objective
Assessment
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 1
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

1. Age group: \> 14-16 years old females and \>16-18 years old male patients.
2. Patients with unilateral or bilateral cleft lip nasal deformity that isn't previously operated.

Exclusion Criteria:

1. Previous rhinoplasty operated CLND cases.
2. Patients who need skeletal base reconstruction.
3. Syndromic cases.
4. Post traumatic nasal deformity.
5. Female patients less than 14 years' old and male patients less than 16 years old.

Primary outcomes:
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)
timeFrame: three years
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)
timeFrame: three years
Secondary outcomes:
measure: Patient's subjective assessment pre and post-operative using Rhinoplasty Outcome Evaluation questionnaire
timeFrame: three years
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Hafsa gamal
Study officials:
References: