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

S

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

  • 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

Exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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