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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-19

Study Completion Date

2017-05-19

Brief Summary

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

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Detailed Description

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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.

Conditions

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Fistula of Soft Palate (Disorder)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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patients with isolated cleft palate

Patients requiring isolated cleft palate repair

Group Type ACTIVE_COMPARATOR

Furlow double opposing z-plasty

Intervention Type PROCEDURE

\* 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

Two flap palatoplasty

Intervention Type PROCEDURE

design the 2-flap palatoplasty, with a 2-layer closure in the hard palate and 3-layer closure in the soft palate,

Patients with isolated cleft palate

Patients requiring isolated cleft palate repair

Group Type ACTIVE_COMPARATOR

Furlow double opposing z-plasty

Intervention Type PROCEDURE

\* 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

Two flap palatoplasty

Intervention Type PROCEDURE

design the 2-flap palatoplasty, with a 2-layer closure in the hard palate and 3-layer closure in the soft palate,

Interventions

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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

Intervention Type 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,

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

9 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes