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

Assiut University

Status: Not yet enrolling

Conditions: Choanal Atresia

Treatments: Procedure: Endoscopic Crossover Flap Repair; Procedure: Transnasal Puncture with Mitomycin C application

Study type: Interventional

Funder types: Other

Identifiers

NCT07173023

endoscopic choanal repair

Details and patient eligibility

About

determine the optimal surgical strategy for achieving

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: Under 72 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Group 1: Transnasal Puncture with Mitomycin C application

Active Comparator group

Description:

* 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

Treatment:

Procedure: Transnasal Puncture with Mitomycin C application

Group 2: Endoscopic Crossover Flap Repair

Active Comparator group

Description:

* 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.

Treatment:

Procedure: Endoscopic Crossover Flap Repair