NCT03167463

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

May 19, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

12 months

First QC Date

May 18, 2017

Last Update Submit

May 24, 2017

Conditions

Otolaryngological Disease

Outcome Measures

Primary Outcomes (1)

  • number of patients with postoperative relief of obstruction

    number of patients will be cure after surgery

    1 month

Study Arms (1)

choanoplasty with flap

EXPERIMENTAL

flap surgery

Procedure: flap

Interventions

flapPROCEDURE

Repair choanal atresia with using flap during surgery

choanoplasty with flap

Eligibility Criteria

Age3 Months - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Any associated medical comorbidity that contraindicates general anesthesia.
  • Refusal of enrollment in the research by care givers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicin

Asyut, Assiut University, 71526, Egypt

RECRUITING

MeSH Terms

Conditions

Otorhinolaryngologic Diseases

Interventions

Surgical Flaps

Intervention Hierarchy (Ancestors)

Surgically-Created StructuresEquipment and Supplies

Study Officials

  • Faculty of medicine Assiut University

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariam Ezzat

CONTACT

+201211161712nanostygad59@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 18, 2017

First Posted

May 30, 2017

Study Start

May 19, 2017

Primary Completion

May 1, 2018

Study Completion

May 1, 2019

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

EG(1)