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临床试验/NCT03167463
NCT03167463Unknown不适用

Stentless Endoscopic Transnasal Transseptal Choanoplasty

Assiut University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年5月19日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
number of patients with postoperative relief of obstruction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Months 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • • 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.

排除标准

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

结局指标

主要结局

number of patients with postoperative relief of obstruction

时间窗: 1 month

number of patients will be cure after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariam Ezzat

principal investigator

Assiut University

研究点 (2)

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