Assessing Post-operative Outcomes After Children's Sistrunk Procedure With or Without a Drain

Официальное название

A Prospective, Randomized, Multi-Center Trial Assessing Post-Operative Outcomes Following Pediatric Sistrunk Procedures With or Without Drain Placement

Обзор

Purpose of the Study: This study looks at how kids recover after a type of neck surgery called the Sistrunk procedure. Some kids have a small tube (called a drain) placed during surgery, and some do not. The goal is to see if using a drain makes a difference in how well they heal. Who Is in the Study: Children who are having surgery to remove a thyroglossal duct cyst-a common lump in the neck that some kids are born with. Main Questions the Study Wants to Answer: Does using a drain lower the chance of problems at the surgery site? Does using a drain change how often kids need more treatment or have to go back to the hospital? What Will Happen: Kids will have the Sistrunk surgery, with or without a drain. Doctors will watch how they heal and check for any problems, like infections, needing more procedures, or going back to the hospital.

Вмешательства

• Процедура Post-surgical drain
  During surgery, at the completion of the Sistrunk procedure, participants in the drain cohort will have a suction drain placed, which will be removed based on standard criteria prior to discharge from the hospital. Wound care following drain removal will be standardized, with instructions for patients to allow the area to heal naturally and to follow a regimen of cleaning and applying topical antibiotic ointment for several days.
• Процедура No post-surgical drain
  Patients will be recovered in SOC manner from Sistrunk surgery without drain placement

Первичные конечные точки

• Occurrence of Hematoma [Срок оценки: 30 days post-procedure]
• Occurrence of Seroma [Срок оценки: 30 days post-procedure]
• Occurrence of Surgical Site Infection (SSI) [Срок оценки: 30 days post-procedure]

Вторичные конечные точки (4)

• Need for Return to Operating Room (OR) or Procedural Intervention [Срок оценки: 30 days post-procedure]
• Hospital Readmission [Срок оценки: 30 days post-procedure]
• Hospital Length of Stay [Срок оценки: 30 days post-procedure]
• Need for Antibiotics [Срок оценки: 30 days post-procedure]

Критерии участия

Критерии включения

• Children aged 18 and younger
• Diagnosis of a <3cm midline neck mass, tract or sinus as determined by preoperative physical examination and imaging
• Patient scheduled for Sistrunk procedure (excision of TGDC)
• Patient assigned to the drain or no drain groups at the time of surgery.
• Sistrunk procedure performed per best practices and standardized per surgical study protocol.
• Patient admitted for overnight observation.
• Thyroglossal duct cyst confirmed on final pathology.

Критерии исключения

• Patients with confirmed bleeding or immunodeficiency disorders as previously documented in electronic medical record.
• Lesions greater than 3cm on preoperative ultrasound or axial imaging
• Lingually positioned lesions.
• Evidence of overt infection at the time of surgery
• Coexistent lesion excision (e.g., branchial cleft cyst excision, thyroidectomy)
• Entry into oropharynx noted during procedure.
• Revision surgery if prior formal Sistrunk performed.
• Patients in whom the surgeon deems a drain is necessary.

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

США · 5 центров

• Children's Hospital Los Angeles — Los Angeles
• Connecticut Children's — Hartford
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
• Boston Children's Hospital — Boston
• University of Rochester Medical Center — Rochester

Публикации

• Brooks JA, Cunningham MJ, Hughes AL, Kawai K, Dombrowski ND, Adil E. Postoperative Disposition Following Pediatric Sistrunk Procedures: A National Database Query. Laryngoscope. 2021 Jul;131(7):E2352-E2355. doi: 10.1002/lary.29331. Epub 2021 Jan 11. PMID 33427321
• Qureshi TA, Suhail A, Zaidi SS, Siddiq W. Is There Any Benefit of Drain Placement on Postoperative Complications in Patients Undergoing the Sistrunk Procedure? Int Arch Otorhinolaryngol. 2015 Oct;19(4):331-5. doi: 10.1055/s-0035-1549156. Epub 2015 Mar 27. PMID 26491480
• Hong P. Is drain placement necessary in pediatric patients who undergo the Sistrunk procedure? Am J Otolaryngol. 2014 Sep-Oct;35(5):628-30. doi: 10.1016/j.amjoto.2014.04.005. Epub 2014 May 4. PMID 24888796
• Brooks JA, Cunningham MJ, Koempel JA, Kawai K, Huang JK, Weitzman RE, Osterbauer B, Hughes AL. To drain or not to drain following a Sistrunk procedure: A dual institutional experience. Int J Pediatr Otorhinolaryngol. 2019 Dec;127:109645. doi: 10.1016/j.ijporl.2019.109645. Epub 2019 Aug 19. PMID 31494373
• Athow AC, Fagg NL, Drake DP. Management of thyroglossal cysts in children. Br J Surg. 1989 Aug;76(8):811-4. doi: 10.1002/bjs.1800760815. PMID 2765833

Идентификаторы

NCT: NCT07148895 · STUDY00010365

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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