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

NCT03055637 | Unknown

• 1 other identifier: 28902051202049
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Fistula of Soft Palate (Disorder)

Outcome Measures

Primary Outcomes (1)

• Incidence of fistula

  6 months

Study Arms (2)

patients with isolated cleft palate

ACTIVE COMPARATOR

Patients requiring isolated cleft palate repair

Procedure: Furlow double opposing z-plasty; Procedure: Two flap palatoplasty

Patients with isolated cleft palate

ACTIVE COMPARATOR

Patients requiring isolated cleft palate repair

Procedure: Furlow double opposing z-plasty; Procedure: Two flap palatoplasty

Interventions

Furlow double opposing z-plasty PROCEDURE

\* 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

Patients with isolated cleft palate; patients with isolated cleft palate

Two flap palatoplasty PROCEDURE

design the 2-flap palatoplasty, with a 2-layer closure in the hard palate and 3-layer closure in the soft palate,

Patients with isolated cleft palate; patients with isolated cleft palate

Eligibility Criteria

• Age: 9 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Patients with hypoplasia of palatal tissue.
• Patients with associated anomalies.
• Patients with associated syndromes.
• Other types of cleft palate.

Sponsors & Collaborators

• Sarah Moustafa Mahmoud Fahmy El-Youtti: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sarah moustafa mahmoud fahmy Al-Ayoutti

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 16, 2017
• Study Start: February 19, 2017
• Primary Completion: May 19, 2017
• Study Completion: May 19, 2017
• Last Updated: February 16, 2017

Record last verified: 2017-02