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Набор скоро начнётся NCT07552545

Full-wrap Versus Conventional Suspension for Reducing Soft Palate Injury Rate in Transoral Surgery

Без фазы С лечением Adenoid Hypertrophy Tonsillar Hypertrophy Nasopharyngeal Diseases Nasopharyngeal Tumors

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: Intraoperative soft palate suspension using the double-strap method., Intraoperative soft palate suspension using the full-wrap method..
Кому может быть актуально
Состояния в реестре: Adenoid Hypertrophy, Tonsillar Hypertrophy, Nasopharyngeal Diseases, Nasopharyngeal Tumors. Базовые параметры: 2 лет — 70 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
Китай
Следующий шаг
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Официальное название

Full-wrap Versus Conventional Suspension for Reducing Soft Palate Injury Rate in Transoral Surgery: A Prospective Randomized Controlled Trial

Обзор

This study aims to evaluate whether the use of full-wrap suspension, compared with the traditional double-strap suspension, can effectively reduce the risk of intraoperative and postoperative soft palate injury in transoral/transnasal pharyngeal surgery. Through a prospective, multicenter, randomized controlled design, this study will provide evidence-based support for the clinical promotion and standardized application of full-wrap suspension.

Подробное описание

This study is a prospective, parallel-group, multicenter clinical study. A total of 138 subjects will be enrolled, including 69 in the control group (using double-strap suspension) and 69 in the experimental group (using full-wrap suspension). By comparing the incidence of soft palate injury, postoperative pain score (VAS), healing time of soft palate injury, incidence of non-soft-palate complications, and System Usability Scale (SUS) score between the two groups, the study aims to investigate whether the use of full-wrap suspension can effectively reduce soft palate injury caused by intraoperative manipulation.

Вмешательства

  • Процедура Intraoperative soft palate suspension using the double-strap method.
    The double-strap suspension method is used intraoperatively. Thin straps are inserted into both nasal cavities, pulled out through the oral cavity, then connected and fixed at both ends to lift the soft palate and ensure adequate exposure of the nasopharynx.
  • Процедура Intraoperative soft palate suspension using the full-wrap method.
    The full-wrap suspension method is used. The fixation string attached to one end of the full-wrap protective sleeve is inserted through the nasal cavity, pulled out through the choanae (posterior nares), and then connected to the main body of the sleeve. The main body is then inserted through the oral cavity, moved into position around the soft palate, adjusted and fixed to suspend the soft palate and expose the nasopharynx.

Первичные конечные точки

  • Incidence of soft palate injury [Срок оценки: 24 hours postoperatively]
Вторичные конечные точки (4)
  • Healing time of soft palate injury [Срок оценки: 24 hours, 1 week, and 1 month postoperatively]
  • Incidence of complications not related to soft palate injury [Срок оценки: 24 hours, 1 week, and 1 month postoperatively]
  • System Usability Scale (SUS) score [Срок оценки: Within 24 hours postoperatively]
  • Postoperative VAS pain score [Срок оценки: 24 hours, 1 week, and 1 month postoperatively]

Критерии участия

Критерии включения

  • Voluntarily sign the informed consent form; for patients aged <18 years, the informed consent form must be signed by their legal guardian.
  • Age between 2 and 70 years (inclusive), male or female.
  • Patients requiring transoral surgery of the nose, pharynx, parapharyngeal space, or skull base, in which intraoperative soft palate suspension is needed.
  • Intact soft palate mucosa with no ulcers, scars, or other lesions before surgery.

Критерии исключения

  • Congenital cleft palate or submucous cleft palate.
  • Patients with limited cervical spine mobility, micrognathia, or other conditions affecting surgical exposure.
  • Pregnant or breastfeeding women.
  • Presence of markedly abnormal laboratory test results, such as significant abnormalities in routine blood tests, blood biochemistry, liver and kidney function, or coagulation function.
  • Patients with active infection or infectious diseases.
  • Severe cardiac insufficiency (NYHA class III-IV).
  • Other conditions deemed unsuitable for surgery after evaluation (e.g., concomitant severe heart, brain, or lung diseases; high anesthetic risk; patients not fit for surgery).

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
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai

Публикации

  • Kim W, Yu HW, Kim SJ, Chai YJ, Choi JY, Lee KE. The anterior neck scar outcomes of conventional thyroidectomy using a wound protector: a multicenter double-blinded randomized controlled trial. Int J Surg. 2024 Jun 1;110(6):3425-3432. doi: 10.1097/JS9.0000000000001288. PMID 38498353
  • Milczuk HA. Effects of oropharyngeal surgery on velopharyngeal competence. Curr Opin Otolaryngol Head Neck Surg. 2012 Dec;20(6):522-6. doi: 10.1097/MOO.0b013e32835873cc. PMID 22929115
  • Robison JG, Otteson TD. Increased prevalence of obstructive sleep apnea in patients with cleft palate. Arch Otolaryngol Head Neck Surg. 2011 Mar;137(3):269-74. doi: 10.1001/archoto.2011.8. PMID 21422312
  • Ross AT, Kazahaya K, Tom LW. Revisiting outpatient tonsillectomy in young children. Otolaryngol Head Neck Surg. 2003 Mar;128(3):326-31. doi: 10.1067/mhn.2003.60. PMID 12646834
  • Gallagher TQ, Wilcox L, McGuire E, Derkay CS. Analyzing factors associated with major complications after adenotonsillectomy in 4776 patients: comparing three tonsillectomy techniques. Otolaryngol Head Neck Surg. 2010 Jun;142(6):886-92. doi: 10.1016/j.otohns.2010.02.019. PMID 20493363
  • Peghini PL, Salcedo JA, Al-Kawas FH. Traumatic uvulitis: a rare complication of upper GI endoscopy. Gastrointest Endosc. 2001 Jun;53(7):818-20. doi: 10.1067/mge.2001.114953. No abstract available. PMID 11375603
  • Allencherril JP, Joseph L. Soft palate trauma induced during GlideScope intubation. J Clin Anesth. 2016 Dec;35:278-280. doi: 10.1016/j.jclinane.2016.08.011. Epub 2016 Oct 10. PMID 27871543
  • Wang L, Ji K, Tu J. Comparative outcomes of microdebrider adenoidectomy, curettage adenoidectomy through oral cavity under 70 endoscope, and endoscopic transoral low-temperature ablation for adenoid hypertrophy. Int J Pediatr Otorhinolaryngol. 2024 Nov;186:112143. doi: 10.1016/j.ijporl.2024.112143. Epub 2024 Oct 20. PMID 39476644

Идентификаторы

NCT: NCT07552545 · ZDWY.BYAFZZX.051

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗