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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 : Unknown
Verified February 2017 by Sarah Moustafa Mahmoud Fahmy El-Youtti, Cairo University.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE February 14, 2017
First Posted Date  ICMJE February 16, 2017
Last Update Posted Date February 16, 2017
Estimated Study Start Date  ICMJE February 19, 2017
Estimated Primary Completion Date May 19, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
Incidence of fistula [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Incidence of Palatal Fistula in Furlow Double-opposing Z-plasty vs. Two-flap Palatoplasty for Cleft Palate Repair
Official Title  ICMJE Evaluation of the Incidence of Palatal Fistula in Furlow Double-opposing Z-plasty vs. Two-flap Palatoplasty for Cleft Palate Repair
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Fistula of Soft Palate (Disorder)
Intervention  ICMJE
  • 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,
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 14, 2017)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 19, 2017
Estimated Primary Completion Date May 19, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Months to 12 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03055637
Other Study ID Numbers  ICMJE 28902051202049
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sarah Moustafa Mahmoud Fahmy El-Youtti, Cairo University
Study Sponsor  ICMJE Sarah Moustafa Mahmoud Fahmy El-Youtti
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date February 2017

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