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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03055637
Enrollment
32
Registered
2017-02-16
Start date
2017-02-19
Completion date
2017-05-19
Last updated
2017-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fistula of Soft Palate (Disorder)

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.

Interventions

PROCEDUREFurlow 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

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

Sponsors

Sarah Moustafa Mahmoud Fahmy El-Youtti
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
9 Months to 12 Months
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Incidence of fistula6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026