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

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

Study Overview

• Status: Unknown
• Conditions: Fistula of Soft Palate (Disorder)
• Intervention / Treatment: Procedure: Furlow double opposing z-plasty; Procedure: Two flap palatoplasty

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 Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: patients with isolated cleft palate; Patients requiring isolated cleft palate repair	Procedure: Furlow double opposing z-plasty; * 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; Procedure: Two flap palatoplasty; design the 2-flap palatoplasty, with a 2-layer closure in the hard palate and 3-layer closure in the soft palate,
Active Comparator: Patients with isolated cleft palate; Patients requiring isolated cleft palate repair	Procedure: Furlow double opposing z-plasty; * 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; Procedure: Two flap palatoplasty; design the 2-flap palatoplasty, with a 2-layer closure in the hard palate and 3-layer closure in the soft palate,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of fistula	6 months

Collaborators and Investigators

• Sponsor: Sarah Moustafa Mahmoud Fahmy El-Youtti

Study record dates

Study Major Dates

• Study Start (Anticipated): February 19, 2017
• Primary Completion (Anticipated): May 19, 2017
• Study Completion (Anticipated): May 19, 2017

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (Actual): February 16, 2017

Study Record Updates

• Last Update Posted (Actual): February 16, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Pathological Conditions, Anatomical; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Fistula; Cleft Palate
• Other Study ID Numbers: 28902051202049

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No