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

Fistula of Soft Palate (Disorder) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03055637
• Other study ID #: 28902051202049
• Status: Not yet recruiting
• Phase: N/A
• First received: February 14, 2017
• Last updated: February 14, 2017
• Start date: February 19, 2017
• Est. completion date: May 19, 2017

Study information

• Verified date: February 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: May 19, 2017
• Est. primary completion date: May 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Palate
• Fistula
• Fistula of Soft Palate (Disorder)

Intervention

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
• 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,

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sarah Moustafa Mahmoud Fahmy El-Youtti

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of fistula		6 months