MedTrace Logo

Fistiulation Rate Following Primary Cleft Repair≤

NCT05166408 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-12-22

No results posted yet for this study

Summary

Aim : The aim of present study was to evaluate the buccinator flap utilization in primary cleft palatoplasty on fistulation rate.

Methodology: forty six patients suffering from complete wide cleft palate were randomly divided into two equal groups: study group: the cleft palate defect was repaired by buccinator myomucosal flap whereas the control group patients' clefts were repaired by Bardach (two flap) palatoplasty during primary repair. All patients evaluated at 1 week,3,6 months interval to detect fistulation and measure palatal length by taking impressions and pouring casts to measure palatal length.

Conditions

  • Cleft Palate

Interventions

PROCEDURE

Buccinator myomucosal flap

Buccinator myomucosal flap for primary cleft palate palatoplasty

PROCEDURE

Bardach two flap palatoplasty

Bardach two flap palatoplasty

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Wael Abdelsamee · Research organizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-24
Primary Completion
2021-01-01
Completion
2021-02-05

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05166408 on ClinicalTrials.gov