Unilateral Cleft Lip Closure - Development of a New Hybrid Technique

Study Overview
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Brief Summary
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Unilateral cleft lips can be treated with different incision techniques. According to a survey by the American Cleft Palate Association, the Millard II technique is currently used by the majority of US cleft surgeons. In this technique, a cleft-sided advancement flap is pivoted from the cleft side into the rotation flap of the non-cleft side, which serves, among other things, to lengthen the lip. However, the rotational component is often insufficient to sufficiently lengthen the lip on the cleft side. The result is a raised red lip, a shortened edge of the philtrum or a so-called pipe-hole deformity. In order to compensate for these deficiencies, a triangular flap is currently being formed in the area of the white roll, which is intended to provide sufficient lengthening. However, the scar of the triangular flaps runs exactly opposite to the aesthetic unit. In addition, it often provides a step formation within the white roll. Knowing the weaknesses of the previous techniques, a further development of the incision was made. The rotational flap of the Millard II technique was extended by extending the incision into the columella - similar to the well-known Mohler technique. The caudal part of the advancement flap of the Millard II technique was extended by a wave incision as known from the Pfeifer procedure.

Official Title
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Unilateral Cleft Lip Closure - Development of a New Hybrid Technique

Conditions
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Complete Unilateral Cleft Lip

Intervention / Treatment
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* Procedure: Unilateral Cleft Lip Repair: Hybrid Technique
* Procedure: Unilateral Cleft Lip Repair: Millard 2 Technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Complete unilateral cleft lip and palate Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 12 Months

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: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: 20 complete unilateral cleft lips are operated; 10 are treated with the Millard II technique and 10 are treated with the new hybrid technique
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unilateral Cleft Lip Repair with the New Hybrid Technique<br> | Procedure: Unilateral Cleft Lip Repair: Hybrid Technique<br>* The rotation flap of the Millard II technique was expanded by extending the incision into the columella - similar to the well-known Mohler technique. The caudal part of the advancement flap of the Millard II technique was lengthened by a wave cut as known from the Pfeiffer procedure. For the vermillion a Noordhoff plasty is applied.<br>|
| Active Comparator: Unilateral Cleft Lip Repair with the Millard II Technique<br> | Procedure: Unilateral Cleft Lip Repair: Millard 2 Technique<br>* A curved incision is marked skirting the philtral ridge. If more length is required a back-cut incision can be performed. The C-flap is outlined by the incision just marked and the incision along red-white border up to the base of the columella. On the cleft side an advancement flap is designed. For the vermillion a Noordhoff plasty is applied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the length of the philtral colomn on the cleft and non-cleft side | Perioperatively, a 3-D scan and photos are taken. Additional photos are also taken after the removal of the stitches, after 3 months and after 6 months. From these, the increase in length of the philtral column can be determined with 3D computer software and with a linear measurement of the photos. | perioperatively to 6 month postoperatively | 
| Angle of the columella | A 3d scan and photos are made perioperatively. From this the angle of the columella can be determined with a 3D Computer software and with a linear measurement of the photos. | perioperatively | 
| Distance from the midpoint of the columella to the lateral alae | Perioperatively, a 3-D scan and photos are taken. The distance can be measured with a 3D computer software and with a linear measurement of the photos. | perioperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cleft Lip, Cleft Lip Repair, Unilateral Cleft Lip