Unilateral Cleft Lip
Conditions
Brief summary
The goal of the study is to compare the cleft lip repair with and without the usage of customized milled nasal conformers in unilateral cleft lip patients on nostril size , alar cartilage and proportion of symmetry to the normal side . * Comparing anthropometric measurements similarity between cleft and normal sides such as; nostril width and height , columellar deviation and nasolabial angle. * Evaluation of degree of similarity using esthetic scales at six months postoperative. Participants will receive nasal conformers intraoperative with follow up of 6 months.
Interventions
PROCEDUREcleft lip repair using fisher technique
Disinfection of the field using Betadine , marking for the incision lines on the lip and vermilion on skin and mucosa , doing incisions as described by Fisher sub anatomic unit repair in 2005 , suturing using vicryl and prolene sutures. suturing the nasal conformer in the cleft side
Sponsors
Mahmoud Akram
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Weeks to 24 Weeks
Healthy volunteers
No
Inclusion criteria
1. Patients of both sexes with unilateral cleft lip. 2. Age range 10 - 24 weeks. 3. Hemoglobin more than 10 gm/dl . 4. Weight more than 10 lbs.
Exclusion criteria
1. Syndromic patients. 2. Patients with conditions contradicting operation. 3. Patients with Bilateral cleft lip. 4. Patients with previous surgeries in lip and nose.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nostril height | 6 months | The greatest vertical distance of the nostril in millimeters . |
| Nostril width | 6 months | This measure was defined as the greatest horizontal distance between the inner medial and lateral borders of the nostril aperture in millimeters. |
| Columellar Deviation Angle | 6 months | The midline columellar deviation from the vertical reference line was measured in degrees. |
| Nasolabial Groove Angle | 6 months | To assess the flare of the nasal alar base, the angle between a line tangential to the outer alar basepoint and the horizontal reference line was measured in degrees. |
Countries
Egypt
Outcome results
None listed