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

Not Applicable

Not yet recruiting

• Conditions: Choanal Atresia

• Registration Number: NCT07173023
• Lead Sponsor: Assiut University

Brief Summary

determine the optimal surgical strategy for achieving

1. long-term outcomes

2. minimizing complications

3. improving outcomes in CCA patients

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.

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-04
• Study First Submitted QC: 2025-09-12
• Last Update Submitted: 2025-09-12
• Study First Posted: 2025-09-15
• Last Update Posted: 2025-09-15
• Primary Completion: 2027-09
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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