Effectiveness of Rotation-advancement and Straight-line Surgical Approaches in Repairing Unilateral Cleft Lip Defect

Study Overview
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Brief Summary
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compare different effects of Rotation-advancement based on the Millard technique and Straight-line based on Fisher modification as surgical approaches in repairing lip defect of unilateral cleft lip patients.

Detailed Description
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Twelve participants with unilateral cleft lip equally divided into two groups. Both groups were photographed preoperative and postoperative. The Control group treated using (Rotation-advancement) based on the Millard technique; and the test group treated using (Straight-line) technique based on Fisher modification.

Official Title
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Comparison of Rotation- Advancement and Straight-line Methods for Repairing of Unilateral Cleft Lip (Randomized Controlled Clinical Trial)

Conditions
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Unilateral Cleft Lip

Intervention / Treatment
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* Procedure: Advancement-rotation approach based on Millard' for repairing lip defect.
* Procedure: Straight-line approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have complete unilateral cleft lip from birth to 4 years old Exclusion Criteria: syndromic cleft patient

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Advancement-rotation approach<br> | Procedure: Advancement-rotation approach based on Millard' for repairing lip defect.<br>* patients were treated using Millard technique is the downward rotation of the medial part of the flap, and lateral advancement of the flap to close and fill the defect. if more lip height is needed; cut- as- you-go by adding a back-cut incision at the end of his rotation incision down toward the philtral ridge of non-clefted side. Moreover; C-flap is used to close nasal sill.<br>|
| Experimental: Straight-line approach<br> | Procedure: Straight-line approach<br>* patients were treated using Straight-Line design based on Fisher modification. C-shaped flap extend from the proposed nasal sill to the origin of philtral column of medial flap as a straight incision to the planned top of the cupid's bow. In addition, to the previous mentioned incision, small inlate incision is needed to length the cleft side on the medial flap. On the other hand, on the lateral flap; two connected triangular incisions are used; one on the vermillion border at Noordhoff's point. And the other one just above the cutaneous margin to improve aesthetic outcome and diminish formed scar.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in vertical and horizontal lip length | Measuring vertical and horizontal lip length of the constructed philtral ridge by caliper | at 3rd, 6th months | 
| change in lip defect | repaired lip is evaluated by direct visual inspection for the patient evaluation. | at 1st, 3rd and 6th months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in degree of labial scaring | Using a five-point scale based on Asher-McDade scoring system: (very good, good, fair, poor, very poor on a scale of 1-5, where 5 represents very poor and 1 represent very good). | at 3rd, 6th months | 
| change in nasal symmetry | measuring total nasal width and nostril width by caliper | at 3rd, 6th months |