A Comparative Study of Endoscopic Choanal Canalization an... | NCT07173023

Status Module

Oversight Module

Description Module

Detailed Description

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.

The transpalatal approach is less favored now due to higher risks of complications such as palatal fistulas and dental deformities.

Endoscopic transnasal techniques are now preferred as they offer better visualization, less morbidity, minimal blood loss, and avoidance palatal growth disturbance.

Simple transnasal endoscopic canalization is technically easy but may have higher rates of restenosis compared to more advanced techniques using mucosal flaps.

Using mucosal flaps in endoscopic surgery can reduce scar tissue and restenosis by providing mucosal coverage and minimizing granulation tissue formation.

Stents are sometimes used for 6-8 weeks, but their necessity and benefits remain debated, with some protocols avoiding stenting altogether.

Topical mitomycin C is used by some surgeons to prevent scar formation, but its effectiveness is still controversial.

There is a need for prospective randomized studies to determine the most suitable approach for long-term success and fewer complications in CCA patients.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1: Transnasal Puncture with Mitomycin C application	Active Comparator	Performed under general anesthesia. Nasal cavities decongested with oxymetazoline. Atretic plate perforated using serial dilators under direct visualization. Additional removal of bony/membranous tissue including the posterior nasal septum as possible. Topical mitomycin C (0.5 mg/mL) applied to the edges of the newly created choana for 2 minutes using cotton pledget in a transparent tube , followed by irrigation with saline. syndromatic patients and patients requiring less time UGA will be included in this group	Procedure: Transnasal Puncture with Mitomycin C application
Group 2: Endoscopic Crossover Flap Repair	Active Comparator	Performed under general anesthesia using a 0° 4 mm endoscope. Elevation of mucosal crossover flaps to cover exposed bone following resection of the atretic plate where one flap is inferiorly based and the other is superiorly based. Precise removal of the posterior vomer and lateral bony plates as needed using cold steel instruments and possible nasal drill. Flaps will be repositioned to minimize exposed bone and promote mucosal healing preventing restenosis.	Procedure: Endoscopic Crossover Flap Repair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transnasal Puncture with Mitomycin C application	Procedure	Performed under general anesthesia. Nasal cavities decongested with oxymetazoline. Atretic plate perforated using serial dilators under direct visualization. Additional removal of bony/membranous tissue including the posterior nasal septum as possible. Topical mitomycin C (0.5 mg/mL) applied to the edges of the newly created choana for 2 minutes using cotton pledget in a transparent tube , followed by irrigation with saline. syndromatic patients and patients requiring less time UGA will be included in this group

Outcomes Module

Primary Outcomes

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

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Ebram Hamdy Dawood, resident doctor	Contact	+201010687046		Abram.17289639@med.aun.edu.eg

Name	Affiliation	Role
ebram hamdy dawood, resident doctor	Assiut University	Principal Investigator
Moustafa omar Mohammed Ali, lecturer	Assiut University	Study Director

References Module

Citations

PubMed Identifier	Type	Citation
	Background	Al-khatib T, Haneef SH, Alhusaini OA, et al. Transnasal puncture technique vs endoscopic transnasal choanal atresia repair. J Otolaryngol ENT Res. 2019;11(2):124?127. DOI: 10.15406/joentr.2019.11.00421
9184974	Background	Deutsch E, Kaufman M, Eilon A. Transnasal endoscopic management of choanal atresia. Int J Pediatr Otorhinolaryngol. 1997 May 4;40(1):19-26. doi: 10.1016/s0165-5876(96)01486-3.
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ID	Term
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D015619	Respiratory System Abnormalities
D010038	Otorhinolaryngologic Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities