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临床试验/NCT07173023
NCT07173023尚未招募不适用

A Comparative Study of Endoscopic Choanal Canalization and Mitomycin C Application vs Endoscopic Crossover Flap Technique

Assiut University0 个研究点目标入组 30 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Rate of restenosis at 12 months postoperatively, defined as symptomatic obstruction confirmed by endoscopy and/or CT scan.

研究概览

简要总结

determine the optimal surgical strategy for achieving

  1. long-term outcomes
  2. minimizing complications
  3. improving outcomes in CCA patients

详细描述

Congenital choanal atresia (CCA) is a relatively common congenital nasal anomaly, characterized by the failure of canalization of the posterior nasal passage during embryological development, which normally occurs between the 4th and 11th weeks of gestation[1]. This developmental failure results in an obstruction-either bony, membranous, or mixed-at the posterior nasal aperture, leading to compromised nasal airflow[1]. Failure of canalization results in a persistent bucco-pharyngeal membrane or naso-buccal blockage, either bony or membranous in structure CCA affects approximately 1 in 5,000 to 8,000 live births, with a slight female predominance (twice as common in females).

Two-thirds of cases are unilateral, while one-third are bilateral. Risk factors include twin pregnancies, chromosomal anomalies, and antithyroid treatment during pregnancy.

Bilateral CCA is a neonatal emergency as infants are obligatory nasal breathing , leading to severe respiratory distress, cyclical cyanosis, and feeding difficulties immediately after birth.

Diagnosis is suspected when a soft catheter cannot pass through the nose and confirmed by CT scan.

Nearly half of the affected neonates have additional syndromic anomalies, such as CHARGE syndrome, highlighting the need for comprehensive evaluation The main goal of surgery is to create an patent nasal airway; techniques have evolved from the traditional transpalatal approach to minimally invasive transnasal endoscopic methods.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
0 Months 至 72 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Age 0-72 months at enrollment.
  • Diagnosis of congenital choanal atresia (unilateral or bilateral) confirmed by nasal endoscopy and CT imaging.
  • Patients presenting with clinical symptoms (e.g., nasal obstruction, respiratory distress, feeding difficulties) or requiring surgical intervention.
  • Guardians willing to provide informed consent and comply with follow-up.

排除标准

  • Acquired (non-congenital) choanal atresia.
  • Previous surgical intervention for choanal atresia.
  • Significant comorbidities contraindicating surgery (e.g., unstable cardiopulmonary status).
  • Incomplete medical records or anticipated inability to complete follow-up.

结局指标

主要结局

Rate of restenosis at 12 months postoperatively, defined as symptomatic obstruction confirmed by endoscopy and/or CT scan.

时间窗: 12 months postoperatively

Rate of restenosis at 12 months postoperatively, defined as symptomatic obstruction confirmed by endoscopy and/or CT scan.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ebram Hamdy Dawood Zaky

Principal Investigator

Assiut University

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