Stentless Endoscopic Transnasal Transseptal Choanoplasty

Otolaryngological Disease Clinical Trial

Official title:

Stentless Endoscopic Transnasal Transseptal Choanoplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03167463
• Other study ID #: SETTC
• Status: Recruiting
• Phase: N/A
• First received: May 18, 2017
• Last updated: May 24, 2017
• Start date: May 19, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: May 2017
• Source: Assiut University
• Contact: Mariam Ezzat
• Phone: +201211161712
• Email: nanostygad59[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Congenital choanal atresia is an abnormality of the posterior nasal passages resulting in complete or partial obstruction of the nasal airways. It has an incidence of 1: 5000 to 8000 live births, with a female predominance. 41% - 72% occur in conjunction with non-syndromic facial abnormalities such as arched palate, cleft lip, and auricular deformities. About 4% present as a component of chromosomally-based syndromes such as (coloboma, heart defect, atresia choanae, retarded growth, genital abnormality, and ear abnormality" and Treacher Collins syndromes.

Previous reports have described the ratio of bony to membranous choanal atresia as 9:1. However, a detailed review of computed tomography study combined with histopathological studies has shown mixed bony-membranous atresia in about 70% of cases and purely bony atresia in 30% of cases.

Description:

Common choanal atresia repair techniques include puncture and dilatation of the atretic area. Endoscopic drilling combined with dissection of the atretic plate and its surrounding structures has been introduced more recently. The approaches have been through transnasal, transpalatal, and transseptal routes. Each of which have experienced varying popularity through time. Regardless of the access route and repair technique used, re-stenosis is a common postoperative complication. To prevent re-stenosis and subsequent re-operation, many authors advocate meticulous preservation of mucosa for use as flaps, which in most cases are combined with postoperative stenting. However, stenting, is controversial

The surgical procedure is performed under general anesthesia. Preoperatively, cotton pledgets soaked in a solution of topical vasoconstrictors are placed against the nasal mucosa for topical decongestion. Local anesthesia is infiltrated into the nasal septum, the atretic plate, the middle turbinate, and the superolateral nasal wall. An endoscopic view of the surgical field is maintained at all times during the procedure using a 4-mm nasal endoscope with 0-degree or 30-degree visual angulation. Firstly, mucosa is elevated bilaterally from the underlying cartilaginous and bony septum on both sides. Then the posterior half of the septum including the vomer is removed using Blakesley forceps and a 1-mm or 2.5-mm diamond burr. After that, the flaps are fashioned using the preserved mucosa. At last, the flaps are secured in position with a thin layer of fibrin glue or gel foam. No packing or stenting is used. The patient is extubated immediately following the procedure and early oral feeding encouraged. The intended length of stay is overnight.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 60 Years

Eligibility

Inclusion Criteria:

• • Denovo cases of unilateral congenital choanal atresia.

• Revision cases of unilateral congenital choanal atresia.

• Denovo cases of bilateral congenital choanal atresia.

• Revision cases of bilateral congenital choanal atresia.

Exclusion Criteria:

• • Any associated medical comorbidity that contraindicates general anesthesia.

• Refusal of enrollment in the research by care givers.

Related Conditions & MeSH terms

• Otolaryngological Disease
• Otorhinolaryngologic Diseases

Intervention

Procedure:
• flap
Repair choanal atresia with using flap during surgery

Locations

Country	Name	City	State
Egypt	Faculty of medicin	Assiut	Assiut University

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with postoperative relief of obstruction	number of patients will be cure after surgery	1 month