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Stentless Endoscopic Transnasal Transseptal Choanoplasty

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ClinicalTrials.gov Identifier: NCT03167463
Recruitment Status : Unknown
Verified May 2017 by Mariam Ezzat, Assiut University.
Recruitment status was:  Recruiting
First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Mariam Ezzat, Assiut University

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.


Condition or disease Intervention/treatment Phase
Otolaryngological Disease Procedure: flap Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stentless Endoscopic Transnasal Transseptal Choanoplasty
Actual Study Start Date : May 19, 2017
Estimated Primary Completion Date : May 1, 2018
Estimated Study Completion Date : May 1, 2019

Arm Intervention/treatment
Experimental: choanoplasty with flap
flap surgery
Procedure: flap
Repair choanal atresia with using flap during surgery




Primary Outcome Measures :
  1. number of patients with postoperative relief of obstruction [ Time Frame: 1 month ]
    number of patients will be cure after surgery



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Ages Eligible for Study:   3 Months to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167463


Contacts
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Contact: Mariam Ezzat +201211161712 nanostygad59@gmail.com

Locations
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Egypt
Faculty of medicin Recruiting
Assiut, Assiut University, Egypt, 71526
Contact: Faculty of medicin Assiut university    0882080177    vdeanpost@med.au.edu.eg   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Faculty of medicine Assiut University Assiut University

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Responsible Party: Mariam Ezzat, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03167463     History of Changes
Other Study ID Numbers: SETTC
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Otorhinolaryngologic Diseases