Stentless Endoscopic Transnasal Transseptal Choanoplasty

NCT ID: NCT03167463

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-19
• Study Completion Date: 2019-05-01

Brief 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.

Detailed 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.

Conditions

Otolaryngological Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

choanoplasty with flap

flap surgery

Group Type: EXPERIMENTAL

flap

Intervention Type: PROCEDURE

Repair choanal atresia with using flap during surgery

Interventions

flap

Repair choanal atresia with using flap during surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mariam Ezzat

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Faculty of medicine Assiut University

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Faculty of medicin

Asyut, Assiut University, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mariam Ezzat

Role: CONTACT

nanostygad59@gmail.com

+201211161712

Facility Contacts

Faculty of medicin Assiut university

Role: primary

vdeanpost@med.au.edu.eg

0882080177

Other Identifiers

SETTC

Identifier Type: -

Identifier Source: org_study_id