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

Not Applicable

• Conditions: Fistula of Soft Palate (Disorder)
• Interventions: Procedure: Furlow double opposing z-plasty; Procedure: Two flap palatoplasty

• Registration Number: NCT03055637
• Lead Sponsor: Sarah Moustafa Mahmoud Fahmy El-Youtti

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-02-14
• Last Update Submitted: 2017-02-14
• Study First Posted: 2017-02-16
• Last Update Posted: 2017-02-16
• Study Start: 2017-02-19
• Primary Completion: 2017-05-19
• Study Completion: 2017-05-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Age of Repair from 9 to 12 months.
2. Isolated Cleft Palate
3. Operation time should nearly be the same for all patients
4. Surgical skills done by same surgeon
5. Both sexes

Exclusion Criteria

1. Patients with hypoplasia of palatal tissue.
2. Patients with associated anomalies.
3. Patients with associated syndromes.
4. Other types of cleft palate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients with isolated cleft palate	Two flap palatoplasty	Patients requiring isolated cleft palate repair
patients with isolated cleft palate	Furlow double opposing z-plasty	Patients requiring isolated cleft palate repair
Patients with isolated cleft palate	Furlow double opposing z-plasty	Patients requiring isolated cleft palate repair
Patients with isolated cleft palate	Two flap palatoplasty	Patients requiring isolated cleft palate repair

Primary Outcome Measures

Name	Time	Method
Incidence of fistula	6 months