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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

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

Condition or disease Intervention/treatment Phase
Fistula of Soft Palate (Disorder) Procedure: Furlow double opposing z-plasty Procedure: Two flap palatoplasty Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of the Incidence of Palatal Fistula in Furlow Double-opposing Z-plasty vs. Two-flap Palatoplasty for Cleft Palate Repair
Estimated Study Start Date : February 19, 2017
Estimated Primary Completion Date : May 19, 2017
Estimated Study Completion Date : May 19, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: patients with isolated cleft palate
Patients requiring isolated cleft palate repair
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
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,




Primary Outcome Measures :
  1. Incidence of fistula [ Time Frame: 6 months ]


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Ages Eligible for Study:   9 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Responsible Party: Sarah Moustafa Mahmoud Fahmy El-Youtti, Sarah moustafa mahmoud fahmy Al-Ayoutti, Cairo University
ClinicalTrials.gov Identifier: NCT03055637     History of Changes
Other Study ID Numbers: 28902051202049
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017

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

Additional relevant MeSH terms:
Jaw Diseases
Fistula
Cleft Palate
Pathological Conditions, Anatomical
Jaw Abnormalities
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities