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
About this trial
This is an interventional prevention trial for Fistula of Soft Palate (Disorder)
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.
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
NCT ID
NCT03055637
First Posted
February 14, 2017
Last Updated
February 14, 2017
Sponsor
Sarah Moustafa Mahmoud Fahmy El-Youtti
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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