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

NCT ID: NCT07173023

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2028-09-30

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.

Conditions

Choanal Atresia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1: Transnasal Puncture with Mitomycin C application

• 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

Group Type: ACTIVE_COMPARATOR

Transnasal Puncture with Mitomycin C application

Intervention Type: 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

Group 2: Endoscopic Crossover Flap Repair

• 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.

Group Type: ACTIVE_COMPARATOR

Endoscopic Crossover Flap Repair

Intervention Type: PROCEDURE

• 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.

Interventions

Transnasal Puncture with Mitomycin C application

• 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

Intervention Type: PROCEDURE

Endoscopic Crossover Flap Repair

• 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 0 Months
• Maximum Eligible Age: 72 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ebram Hamdy Dawood Zaky

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ebram hamdy dawood, resident doctor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Moustafa omar Mohammed Ali, lecturer

Role: STUDY_DIRECTOR

Assiut University

ezzat mohammed saleh, professor doctor

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Ebram Hamdy Dawood, resident doctor

Role: CONTACT

Abram.17289639@med.aun.edu.eg

+201010687046

References

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 9184974 (View on PubMed)

Bajin MD, Onay O, Gunaydin RO, Unal OF, Yucel OT, Akyol U, Aydin C. Endonasal choanal atresia repair; evaluating the surgical results of 58 cases. Turk J Pediatr. 2021;63(1):136-140. doi: 10.24953/turkjped.2021.01.016.

Reference Type: BACKGROUND

PMID: 33686836 (View on PubMed)

Llorente JL, Lopez F, Morato M, Suarez V, Coca A, Suarez C. Endoscopic treatment of choanal atresia. Acta Otorrinolaringol Esp. 2013 Nov-Dec;64(6):389-95. doi: 10.1016/j.otorri.2013.05.001. Epub 2013 Jul 27. English, Spanish.

Reference Type: BACKGROUND

PMID: 23896489 (View on PubMed)

Stamm AC, Pignatari SS. Nasal septal cross-over flap technique: a choanal atresia micro-endoscopic surgical repair. Am J Rhinol. 2001 Mar-Apr;15(2):143-8. doi: 10.2500/105065801781543718.

Reference Type: BACKGROUND

PMID: 11345154 (View on PubMed)

Other Identifiers

endoscopic choanal repair

Identifier Type: -

Identifier Source: org_study_id