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

Sarah Moustafa Mahmoud Fahmy El-Youtti

Status: Unknown

Conditions: Fistula of Soft Palate (Disorder)

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03055637

28902051202049

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 9 to 12 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

patients with isolated cleft palate

Active Comparator group

Description:

Patients requiring isolated cleft palate repair

Treatment:

Procedure: Two flap palatoplasty

Procedure: Furlow double opposing z-plasty

Patients with isolated cleft palate

Active Comparator group

Description:

Patients requiring isolated cleft palate repair

Treatment:

Procedure: Two flap palatoplasty

Procedure: Furlow double opposing z-plasty