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

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ClinicalTrials.gov Identifier: NCT03055637
Recruitment Status : Not yet recruiting
First Posted : February 16, 2017
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Sarah Moustafa Mahmoud Fahmy El-Youtti, Cairo University

February 14, 2017
February 16, 2017
February 16, 2017
February 19, 2017
May 19, 2017   (Final data collection date for primary outcome measure)
Incidence of fistula [ Time Frame: 6 months ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of the Incidence of Palatal Fistula in Furlow Double-opposing Z-plasty vs. Two-flap Palatoplasty for Cleft Palate Repair
Evaluation of the Incidence of Palatal Fistula in Furlow Double-opposing Z-plasty vs. Two-flap Palatoplasty for Cleft Palate Repair
Evaluation of the incidence of palatal fistula in Furlow double-opposing z-plasty versus two-flap palatoplasty for cleft palate repair.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Fistula of Soft Palate (Disorder)
  • 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
  • Procedure: 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,
  • Active Comparator: patients with isolated cleft palate
    Patients requiring isolated cleft palate repair
    Interventions:
    • Procedure: Furlow double opposing z-plasty
    • Procedure: Two flap palatoplasty
  • Active Comparator: Patients with isolated cleft palate
    Patients requiring isolated cleft palate repair
    Interventions:
    • Procedure: Furlow double opposing z-plasty
    • Procedure: Two flap palatoplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
32
Same as current
May 19, 2017
May 19, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
9 Months to 12 Months   (Child)
Yes
Not Provided
 
 
NCT03055637
28902051202049
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Sarah Moustafa Mahmoud Fahmy El-Youtti, Cairo University
Sarah Moustafa Mahmoud Fahmy El-Youtti
Not Provided
Not Provided
Cairo University
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP