MRI Assessment of Velopharyngeal Anatomy After Modified Furlow-Buccinator Flap in Late Primary Palate Repair
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Modified Furlow Palatoplasty combined with buccinator myomucosal flap.
- Кому может быть актуально
- Состояния в реестре: Cleft Palate, Cleft Palate, Unilateral, Complete, Cleft Lip, Cleft Alveolus and Cleft Palate, Cleft Palate Repair. Базовые параметры: от 5 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Египет
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
MRI Assessment of Velopharyngeal Anatomy in Late Primary Cleft Palate Repair Using Modified Furlow With Buccinator Myomucosal Flap: A Case Series Study
Обзор
The goal of this case series study is to learn if magnetic resonance imaging (MRI) can show how well the palate and throat muscles work at rest and during speech after late cleft palate repair. The surgery uses a technique in which the muscle from the cheek is used to close the gap and repair the cleft and therefore improve speech. The study will answer the question of whether this technique will provide better closure and improved speech in the participants who have not received early treatment. The participants will have the surgery and then have MRI scans 6 months after surgery while resting and speaking specific sounds. Complete speech assessments will also be done 6 months after surgery.
Подробное описание
This study will include about 10 children, age 5 years and older, with cleft palate who have not had previous palate surgery. All participants will have surgery using the modified Furlow palatoplasty with a buccinator myomucosal flap. This method is designed to improve muscle function and speech outcomes in children who have late cleft palate repair.
Six months after surgery, participants will have MRI scans. The scans will take pictures of the palate and throat muscles while resting and while saying sounds such as "EEE" and "SSS." These images will help researchers see how well the muscles close the gap between the nose and mouth during speech.
Participants will also have a speech evaluation six months after surgery. This will include articulation tests and scoring of speech clarity and nasal resonance.
The study will take place at Cairo University and New Giza University Hospital. By combining MRI results with speech assessments, researchers aim to show whether MRI is a useful tool for evaluating muscle function after this type of cleft palate repair. The findings may help guide future treatment for children who cannot have early surgery.
Вмешательства
- Процедура Modified Furlow Palatoplasty combined with buccinator myomucosal flap
The procedure is performed under general anesthesia. After marking a palatal Z-plasty and infiltrating local anesthetic, the parotid duct and buccinator flap donor site are identified. On the left side, a posteriorly based oral myomucosal flap and an anteriorly based nasal flap are created by incising from the uvula to the hard-soft palate junction and laterally toward the hamulus. The levator muscle is fully detached. A small anteriorly based nasal flap is added. On the right side, an anteriorl
Первичные конечные точки
- Velopharyngeal assessment [Срок оценки: 6 Months]
- VP ratio [Срок оценки: 6 months]
- EVP ratio [Срок оценки: 6 months]
Вторичные конечные точки (3)
- Speech intelligibility [Срок оценки: 6 months after surgery]
- Hypernasality [Срок оценки: 6 months after surgery]
- Nasal emission [Срок оценки: 6 months after surgery]
Критерии участия
Критерии включения
- Non-syndromic cleft palate (La Veau I-IV)
- No prior palatal surgery
- Consent for MRI and follow-up
Критерии исключения
- Syndromic clefts or associated craniofacial anomalies.
- Systemic co-morbidities
- Previous palatal surgery.
- Contraindications to MRI.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Египет · 1 центр
- Cairo University — Cairo
Публикации
- MacIsaac MF, Elsamna SL, Quintana JF, Rottgers SA, Halsey JN. MRI assessment of velopharyngeal dysfunction: A comprehensive primer for radiologists. Pediatr Radiol. 2025 May;55(6):1088-1104. doi: 10.1007/s00247-025-06180-y. Epub 2025 Feb 14. PMID 39953298
- Perry JL, Snodgrass TD, Gilbert IR, Sutton BP, Baylis AL, Weidler EM, Tse RW, Ishman SL, Sitzman TJ. Establishing a Clinical Protocol for Velopharyngeal MRI and Interpreting Imaging Findings. Cleft Palate Craniofac J. 2024 May;61(5):748-758. doi: 10.1177/10556656221141188. Epub 2022 Nov 30. PMID 36448363
- Haenssler AE, Fang X, Perry JL. Effective Velopharyngeal Ratio: A More Clinically Relevant Measure of Velopharyngeal Function. J Speech Lang Hear Res. 2020 Nov 13;63(11):3586-3593. doi: 10.1044/2020_JSLHR-20-00305. Epub 2020 Sep 25. PMID 32976083
- Aboulhassan MA, Aly TM, Akram Khodir MM, Moussa HM, Hussein MA. Quantitative Evaluation of Palatal Lengthening After Cleft Palate Repair When a Buccal Flap Is Routinely Combined With Furlow's Z-Plasty. Ann Plast Surg. 2022 Mar 1;88(3):288-292. doi: 10.1097/SAP.0000000000002964. PMID 34393194
Идентификаторы
NCT: NCT07514091 · MRI-VPI-FURL-BMF