Choanal AtresiaNCT07173023
A Comparative Study of Endoscopic Choanal Canalization and Mitomycin C Application vs Endoscopic Crossover Flap Technique
A study testing Transnasal Puncture with Mitomycin C application and Endoscopic Crossover Flap Repair in people with Choanal Atresia, run by Assiut University.
Trial summary
determine the optimal surgical strategy for achieving 1. long-term outcomes 2. minimizing complications 3. improving outcomes in CCA patients Read more about this study
- Who is it for?
- Ages 0 to 72 months
- Conditions the study is for
- Choanal Atresia
- What is being tested?
- Transnasal Puncture with Mitomycin C application and Endoscopic Crossover Flap Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 72 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
determine the optimal surgical strategy for achieving
- long-term outcomes
- minimizing complications
- improving outcomes in CCA patients
Read the 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
- Being tested
- Transnasal Puncture with Mitomycin C application, Endoscopic Crossover Flap Repair
- Medical subject headings
- Choanal Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transnasal Puncture with Mitomycin C applicationProcedure or surgery
- 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
Endoscopic Crossover Flap RepairProcedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: Endoscopic Crossover Flap Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Choanal AtresiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebram Hamdy Dawood Zaky, Assiut University
- Investigators
- ebram hamdy dawood, resident doctor, Principal investigator, Assiut UniversityMoustafa omar Mohammed Ali, lecturer, Study director, Assiut Universityezzat mohammed saleh, professor doctor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173023
- Sponsor's protocol ID
- endoscopic choanal repair
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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
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.
PubMed 9184974Bajin 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.
PubMed 33686836Llorente 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.
PubMed 23896489Stamm 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.
PubMed 11345154
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Endoscopic Choanal Canalization and Mitomycin C Application vs Endoscopic Crossover Flap Technique
- ClinicalTrials.gov ID
- NCT07173023
- Acronym / sponsor ID
- endoscopic choanal repair
- Conditions
- Choanal Atresia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
determine the optimal surgical strategy for achieving
- long-term outcomes
- minimizing complications
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Transnasal Puncture with Mitomycin C application | Active comparator | Procedure: 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 2: Endoscopic Crossover Flap Repair | Active comparator | 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. |
Who may qualify
- Ages
- 0 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Group 1: Transnasal Puncture with Mitomycin C application |
| 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. | Procedure or surgery | Group 2: Endoscopic Crossover Flap Repair |
Primary outcome
Rate of restenosis at 12 months postoperatively, defined as symptomatic obstruction confirmed by endoscopy and/or CT scan.
Time frame: 12 months postoperatively
Rate of restenosis at 12 months postoperatively, defined as symptomatic obstruction confirmed by endoscopy and/or CT scan.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- BackgroundAl-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
- Background: PubMed 9184974Deutsch 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.
- Background: PubMed 33686836Bajin 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.
- Background: PubMed 23896489Llorente 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.
- Background: PubMed 11345154Stamm 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ebram hamdy dawood, resident doctor principal investigator
Assiut University
Moustafa omar Mohammed Ali, lecturer study director
Assiut University
ezzat mohammed saleh, professor doctor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Transnasal Puncture with Mitomycin C application and Endoscopic Crossover Flap Repair in people with Choanal Atresia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ebram Hamdy Dawood, resident doctor (+201010687046, Abram.17289639@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of restenosis at 12 months postoperatively, defined as symptomatic obstruction confirmed by endoscopy and/or CT scan. (time frame: 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07173023, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.