Furlow With Buccinator and Fistula Formation

NCT07840911 — Not applicable, Not yet recruiting, 20 participants, Fayoum University

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• Fistula Formation in Patients With Cleft Palate Following Primary Furlow Palatoplasty With Buccal Myomucosal Flap Versus Two Flap Palatoplasty

RegistryNCT07840911
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: triple, treatment
Enrollment20 (Estimated)
SponsorFayoum University (Other)
ConditionsCleft Palate
Interventionsfurlow with buccinator, two flap palatoplasty (Procedure)
Datesstart 2026-09-25 (estimated), primary completion 2027-09-01 (estimated), completion 2027-09-30 (estimated), first posted 2026-09-25, last updated 2026-09-25

Related Papers Related Patents Related Grants Related Experts
All trials for Cleft Palate All trials of furlow with buccinator All trials of two flap palatoplasty

-Summary

Furlow with buccal myomucosal flap (group 1) Local anesthesia with a vasoconstrictor will be injected at the beginning of the surgery after Z- flap outline marking. On the left side, myomucosal posteriorly based flap will be incised containing the levator palateni muscle with a 60◦ angle and elevated. Another small anteriorly-based nasal mucosa flap will be created. On the opposite side, oral mucosal anteriorly based flap with a 90◦ angle will be incised and elevated. Palatal muscle will be stripped and posteriorly based myomucosal flap was created containing palatal muscle and nasal mucosa. Nasal mucosa will be sutured followed by oral mucosa with minimal palatal muscle overlapping. The oral mucosa defect will be filled with BMMF Two flap palatoplasty surgical steps (group 2) A bilateral tongue like palatal flaps will be incised and elevated from the incisive foramen anteriorly to the hamulus posteriorly medial to the teeth and extended around the cleft area. Palatal muscles will be detached from the palatal shelves and separating it from the nsal mucosa. Nasal layer will be the firstly closed, followed by the muscle and oral mucosal layers. In case of the presence of a bare area of bone, it will be left to heal by secondary intention

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+Arms and interventions

ArmTypeInterventionsDescription
furlow with buccinatorExperimentalProcedure: furlow with buccinator
two flap palatoplastyActive comparatorProcedure: two flap palatoplasty
  • furlow with buccinator (Procedure): clefted patients were treated with furlow with buccinator flap
  • two flap palatoplasty (Procedure): clefted patients were treated with two flap palatoplasty

+Outcome measures

Primary outcomes

  • fistula formation [6 months postoperative]: assessment the fistula formation after cleft palate repair by determination the site of fistula and time at which appear

+Eligibility

Sex: All, ages: 9 Months to 12 Months

Inclusion Criteria:

* 9-12 months old childreen with complete cleft lip and palate, nonsyndromic.
* lip and palate repair performed by one craniofacial surgeon

Exclusion Criteria:

* Patients with syndromic cleft lip.
* Redu cases
* Bilateral cleft lip
* Associated Cardiac anomalies.
* Any systemic condition