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Objective Assessment for Cleft Lip Nasal Deformity Correction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03683199
Recruitment Status : Not yet recruiting
First Posted : September 25, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Hafsa Gamal Muhammad bakheet, Assiut University

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

Condition or disease Intervention/treatment Phase
Nose; Anomaly Procedure: Rhinoplasty Not Applicable

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.

"Face Master" is a computer software program designed by Ozkul, et al., in 2009. It has Specific icons and help files that are prepared for measuring some angles and ratios of the nose and its relation to the face. These icons are readily accessible from the toolbar area and provide automatic calculation and recording of these parameters at the spread sheet. Other parameters can also be measured, as long as user records the measurements manually.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Objective Assessment for Cleft Lip Nasal Deformity Correction
Estimated Study Start Date : October 15, 2018
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cleft lip nasal deformity

•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.

A computer software program "Face Master" which was designed by Ozkul in 2009, will be used to measure nose related angels and ratios.

•MSCT on the nose to get idea about nasal skeleton pre-operative for proper design of the operative strategy, and it will be done post-operative for assessment.

Procedure: Rhinoplasty

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.





Primary Outcome Measures :
  1. Objective Assessment for cleft lip nasal deformity correction using computer software program (to compare some nasal lengths in millimeters before and after correction) [ Time Frame: three years ]
    we will use computer software program, called face master, to compare the columellar length in millimeters and inter-alar dimensions in millimeters before and after the surgical correction

  2. Objective Assessment for cleft lip nasal deformity correction using computer software program (to compare some nasal lengths in millimeters before and after correction) [ Time Frame: three years ]
    Using computer software program, called face master. we will compare the angle of sepal deviation in degrees, before and after cleft nose rhinoplasty


Secondary Outcome Measures :
  1. Patient's subjective assessment pre and post-operative using Rhinoplasty Outcome Evaluation questionnaire [ Time Frame: three years ]

    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).




Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   1- Age group: > 14-16 years old females and >16-18 years old male patients
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683199


Contacts
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Contact: Hafsa Gamal, M.D. student 01003411742 hafsa_90@aun.edu.eg
Contact: Mostafa El sonbaty, professor 01003142066 mustafa_elsonbaty@hotmail.com

Locations
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Egypt
Hafsa gamal
Assiut, Egypt, 0020
Contact: Hafsa Gamal, Assistant teacher    01003411742    hafsa_90@aun.edu   
Contact: Mostafa El sonbaty, Prof.         
Sponsors and Collaborators
Assiut University

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Responsible Party: Hafsa Gamal Muhammad bakheet, Assistant teacher, Assiut University
ClinicalTrials.gov Identifier: NCT03683199    
Other Study ID Numbers: AUH
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hafsa Gamal Muhammad bakheet, Assiut University:
Secondary
Cleft
Lip
Nose
Deformity
Correction
Objective
Assessment
Additional relevant MeSH terms:
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Cleft Lip
Congenital Abnormalities
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities