Evaluation of the Incidence of Palatal Fistula in Furlow Double-opposing Z-plasty vs. Two-flap Palatoplasty for Cleft Palate Repair

Study Overview
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Brief Summary
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Evaluation of the incidence of palatal fistula in Furlow double-opposing z-plasty versus two-flap palatoplasty for cleft palate repair.

Detailed Description
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Up to 6 hours before the scheduled arrival time, formula-fed babies may be given formula. Up to 4 hours before the scheduled arrival time, breastfed babies may nurse. Up to 2 hours before the scheduled arrival time, give only clear liquids. Clear liquids include water, Pedialyte®, Kool-Aid® and juices you can see through, such as apple or white grape juice. In the 2 hours before the scheduled arrival time, give nothing to eat or drink. Induction of general anaesthesia will be administered followed by local anaethesia. Then, Surgical prodecure will be done either following the conventional two flap palatoplasty technique or the Furlow double-opposing z-plasty technique.

Official Title
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Evaluation of the Incidence of Palatal Fistula in Furlow Double-opposing Z-plasty vs. Two-flap Palatoplasty for Cleft Palate Repair

Conditions
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Fistula of Soft Palate (Disorder)

Intervention / Treatment
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* Procedure: Furlow double opposing z-plasty
* Procedure: Two flap palatoplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of Repair from 9 to 12 months. Isolated Cleft Palate Operation time should nearly be the same for all patients Surgical skills done by same surgeon Both sexes Exclusion Criteria: Patients with hypoplasia of palatal tissue. Patients with associated anomalies. Patients with associated syndromes. Other types of cleft palate.

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: patients with isolated cleft palate<br>Patients requiring isolated cleft palate repair | Procedure: Furlow double opposing z-plasty<br>* * Furlow, (1986) has described a technique for palatoplasty combining the principles of mucosal lengthening with creation of an intact muscular sling in the palate with double opposing Z-plasty. On the soft palate, mirror image Z-plasties are drawn, one for the nasal musoca and the other oral flaps, the nasal flaps are developed and closed first .The oral flaps are then approximated. The defect created usually closes readily. The closure lines of the two soft plate layers do not overlap, minimizing the potential for contracture. Also, this repair permits closure of the hard palate without lateral incisions<br>Procedure: Two flap palatoplasty<br>* design the 2-flap palatoplasty, with a 2-layer closure in the hard palate and 3-layer closure in the soft palate,<br>|
| Active Comparator: Patients with isolated cleft palate<br>Patients requiring isolated cleft palate repair | Procedure: Furlow double opposing z-plasty<br>* * Furlow, (1986) has described a technique for palatoplasty combining the principles of mucosal lengthening with creation of an intact muscular sling in the palate with double opposing Z-plasty. On the soft palate, mirror image Z-plasties are drawn, one for the nasal musoca and the other oral flaps, the nasal flaps are developed and closed first .The oral flaps are then approximated. The defect created usually closes readily. The closure lines of the two soft plate layers do not overlap, minimizing the potential for contracture. Also, this repair permits closure of the hard palate without lateral incisions<br>Procedure: Two flap palatoplasty<br>* design the 2-flap palatoplasty, with a 2-layer closure in the hard palate and 3-layer closure in the soft palate,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of fistula |  | 6 months |