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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

Primary Purpose

Fistula of Soft Palate (Disorder)

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Furlow double opposing z-plasty
Two flap palatoplasty
Sponsored by
Sarah Moustafa Mahmoud Fahmy El-Youtti
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fistula of Soft Palate (Disorder)

Eligibility Criteria

9 Months - 12 Months (Child)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    patients with isolated cleft palate

    Patients with isolated cleft palate

    Arm Description

    Patients requiring isolated cleft palate repair

    Patients requiring isolated cleft palate repair

    Outcomes

    Primary Outcome Measures

    Incidence of fistula

    Secondary Outcome Measures

    Full Information

    First Posted
    February 14, 2017
    Last Updated
    February 14, 2017
    Sponsor
    Sarah Moustafa Mahmoud Fahmy El-Youtti
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03055637
    Brief Title
    Evaluation of the Incidence of Palatal Fistula in Furlow Double-opposing Z-plasty vs. Two-flap Palatoplasty for Cleft Palate Repair
    Official Title
    Evaluation of the Incidence of Palatal Fistula in Furlow Double-opposing Z-plasty vs. Two-flap Palatoplasty for Cleft Palate Repair
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 19, 2017 (Anticipated)
    Primary Completion Date
    May 19, 2017 (Anticipated)
    Study Completion Date
    May 19, 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Sarah Moustafa Mahmoud Fahmy El-Youtti

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fistula of Soft Palate (Disorder)

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    patients with isolated cleft palate
    Arm Type
    Active Comparator
    Arm Description
    Patients requiring isolated cleft palate repair
    Arm Title
    Patients with isolated cleft palate
    Arm Type
    Active Comparator
    Arm Description
    Patients requiring isolated cleft palate repair
    Intervention Type
    Procedure
    Intervention Name(s)
    Furlow double opposing z-plasty
    Intervention Description
    * 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
    Intervention Type
    Procedure
    Intervention Name(s)
    Two flap palatoplasty
    Intervention Description
    design the 2-flap palatoplasty, with a 2-layer closure in the hard palate and 3-layer closure in the soft palate,
    Primary Outcome Measure Information:
    Title
    Incidence of fistula
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Months
    Maximum Age & Unit of Time
    12 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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 Both sexes Exclusion Criteria: Patients with hypoplasia of palatal tissue. Patients with associated anomalies. Patients with associated syndromes. Other types of cleft palate.

    12. IPD Sharing Statement

    Learn more about this trial

    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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