Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy
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: Lateral pharyngoplasty, Tonsillectomy.
- Кому может быть актуально
- Состояния в реестре: Sleep-Disordered Breathing, Sleep Apnea Syndromes in Children, Sleep Apnea, Obstructive, Tonsillitis. Базовые параметры: 3 лет — 17 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
- США
- 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
Post-operative Outcomes of Tonsillectomy With Lateral Pharyngoplasty Versus Tonsillectomy Alone in Children: a Randomized Controlled Trial
Обзор
The goal of this treatment study is to determine if doing lateral pharyngoplasty with tonsillectomy is better for children than doing tonsillectomy alone. The main questions it aims to answer are: * Do children experience less pain after surgery when lateral pharyngoplasty is performed with tonsillectomy compared to tonsillectomy alone? * Do children eat/drink better when lateral pharyngoplasty is performed with tonsillectomy compared to tonsillectomy alone? * Is there a lower risk of bleeding after tonsillectomy when lateral pharyngoplasty is performed? Researchers will compare children undergoing tonsillectomy and lateral pharyngoplasty with children undergoing tonsillectomy alone to see if the participants experience less pain, better oral intake, and less bleeding complications after surgery. Parents of participants will be asked to record pain scores and pain medications given, approximate amounts of daily oral intake, and any complications after surgery.
Подробное описание
This is a randomized controlled trial to elucidate the benefits of performing lateral pharyngoplasty with tonsillectomy and encourage its use as a standard of care procedure. Participants will be randomized to receive either tonsillectomy +/- adenoidectomy or tonsillectomy +/- adenoidectomy with lateral pharyngoplasty (research intervention), with lateral pharyngoplasty referring to the placement two figure-of-8 sutures with 3-0 vicryl to reapproximate the anterior and posterior tonsillar pillars on each side. The investigators' hypothesis is that participants undergoing lateral pharyngoplasty will experience less pain, lower post-tonsillectomy hemorrhage rate, and a faster return to normal oral intake than participants undergoing tonsillectomy alone.
Вмешательства
- Процедура Lateral pharyngoplasty
Two figure-of-8 sutures using 3-0 vicryl are used to approximate the anterior and posterior tonsillar pillars and reconstruct the continuous mucosal covering of the lateral pharyngeal walls. - Процедура Tonsillectomy
Extracapsular tonsillectomy
Первичные конечные точки
- Level of post-operative pain [Срок оценки: Change between baseline (immediately post-op) through 6 weeks after surgery]
- Number of participants with post-tonsillectomy hemorrhage requiring surgical intervention [Срок оценки: Change between baseline (immediately post-op) through 6 weeks after surgery]
- Number of participants with post-tonsillectomy hemorrhage not requiring surgical intervention [Срок оценки: Change between baseline (immediately post-op) through 6 weeks after surgery]
Вторичные конечные точки (1)
- Post-operative duration (in days) to normal oral intake [Срок оценки: Change between baseline (immediately post-op) through 6 weeks after surgery]
Критерии участия
Критерии включения
- Participants ages 3-17 years of age undergoing tonsillectomy +/- adenoidectomy at Loma Linda University Health
Критерии исключения
- Subjects with congenital syndromes and/or developmental delay
- Subjects with cancer
- Subjects with gastrostomy tube use or dependence
- Subjects undergoing intracapsular tonsillectomy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
США · 4 центра
- Loma Linda University Professional Building - Murrieta — Murrieta
- Loma Linda University ENT/Head & Neck Surgery — Riverside
- Pediatric Ear, Nose, and Throat Surgery and Audiology — San Bernardino
- SAC Health - ENT Clinic — San Bernardino
Публикации
- Genc E, Hanci D, Ergin NT, Dal T. Can mucosal sealing reduce tonsillectomy pain? Int J Pediatr Otorhinolaryngol. 2006 Apr;70(4):725-30. doi: 10.1016/j.ijporl.2005.12.005. Epub 2006 Jan 18. PMID 16414127
- Kim JS, Kim BG, Kim DH, Hwang SH. Efficacy of pillar suture for post-tonsillectomy morbidity in children: a meta-analysis. Braz J Otorhinolaryngol. 2021 Sep-Oct;87(5):583-590. doi: 10.1016/j.bjorl.2019.12.007. Epub 2020 Jan 25. PMID 32057680
- Ramjettan S, Singh B. Are sutured faucial pillars really an advantage in tonsillectomy? S Afr J Surg. 1996 Nov;34(4):189-91. PMID 9015944
- Shu Y, Yao HB, Yang DZ, Wang B. Postoperative characteristics of combined pharyngoplasty and tonsillectomy versus tonsillectomy in children with obstructive sleep apnea syndrome. Arch Argent Pediatr. 2018 Oct 1;116(5):316-321. doi: 10.5546/aap.2018.eng.316. English, Spanish. PMID 30204981
- Wulu JA, Chua M, Levi JR. Does suturing tonsil pillars post-tonsillectomy reduce postoperative hemorrhage?: A literature review. Int J Pediatr Otorhinolaryngol. 2019 Feb;117:204-209. doi: 10.1016/j.ijporl.2018.12.003. Epub 2018 Dec 4. PMID 30611028
Идентификаторы
NCT: NCT05575401 · 5210282