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Clinical Trials/NCT03055637
NCT03055637
Unknown
Not Applicable

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-Youtti0 sites32 target enrollmentFebruary 19, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fistula of Soft Palate (Disorder)
Sponsor
Sarah Moustafa Mahmoud Fahmy El-Youtti
Enrollment
32
Primary Endpoint
Incidence of fistula
Last Updated
9 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
February 19, 2017
End Date
May 19, 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sarah Moustafa Mahmoud Fahmy El-Youtti
Responsible Party
Sponsor Investigator
Principal Investigator

Sarah Moustafa Mahmoud Fahmy El-Youtti

Sarah moustafa mahmoud fahmy Al-Ayoutti

Cairo University

Eligibility Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Incidence of fistula

Time Frame: 6 months

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