Objective Assessment for Cleft Lip Nasal Deformity Correction

NCT03683199 | Completed DMC

• 1 other identifier: AUH
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Conditions

Nose; Anomaly

Keywords

Secondary; Cleft; Lip; Nose; Deformity; Correction; Objective; Assessment

Outcome Measures

Primary Outcomes (2)

• 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

  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

  three years

Secondary Outcomes (1)

• Patient's subjective assessment pre and post-operative using Rhinoplasty Outcome Evaluation questionnaire

  three years

Study Arms (1)

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.

Procedure: Rhinoplasty

Interventions

Rhinoplasty PROCEDURE

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.

Cleft lip nasal deformity

Eligibility Criteria

• Age: 12 Years+
• Gender Eligibility Details: 1- Age group: \> 14-16 years old females and \>16-18 years old male patients
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Hafsa gamal

Asyut, 0020, Egypt

Location

MeSH Terms

Conditions

Congenital Abnormalities; Neoplasm Metastasis; Lymphoid Interstitial Pneumonia

Interventions

Rhinoplasty

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Nasal Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

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: Assistant teacher

Model Details: 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.

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 25, 2018
• Study Start: October 15, 2018
• Primary Completion: August 20, 2020
• Study Completion: August 20, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

EG (1)