Stentless Endoscopic Transnasal Transseptal Choanoplasty
Primary Purpose
Otolaryngological Disease
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
flap
Sponsored by
About this trial
This is an interventional treatment trial for Otolaryngological Disease
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.
Sites / Locations
- Faculty of medicinRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
choanoplasty with flap
Arm Description
flap surgery
Outcomes
Primary Outcome Measures
number of patients with postoperative relief of obstruction
number of patients will be cure after surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03167463
Brief Title
Stentless Endoscopic Transnasal Transseptal Choanoplasty
Official Title
Stentless Endoscopic Transnasal Transseptal Choanoplasty
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 19, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Anticipated)
Study Completion Date
May 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otolaryngological Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
choanoplasty with flap
Arm Type
Experimental
Arm Description
flap surgery
Intervention Type
Procedure
Intervention Name(s)
flap
Intervention Description
Repair choanal atresia with using flap during surgery
Primary Outcome Measure Information:
Title
number of patients with postoperative relief of obstruction
Description
number of patients will be cure after surgery
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariam Ezzat
Phone
+201211161712
Email
nanostygad59@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faculty of medicine Assiut University
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicin
City
Assiut
State/Province
Assiut University
ZIP/Postal Code
71526
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faculty of medicin Assiut university
Phone
0882080177
Email
vdeanpost@med.au.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Stentless Endoscopic Transnasal Transseptal Choanoplasty
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