临床试验/NCT07303673

NCT07303673已完成不适用

Coblation Assisted Dilatation Versus Modified Maddern Procedure in Subglottic and Cervical Tracheal Stenosis: a Randomized Clinical Trial

Mansoura University1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2024年6月1日最近更新: 2025年12月26日

试验速览

阶段: 不适用
状态: 已完成
发起方: Mansoura University
入组人数: 30
试验地点: 1
主要终点: Airway diameter

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study compares the effectiveness of Coblation-assisted endoscopic airway dilatation with the modified Maddern procedure-which involves endoscopic excision of scar tissue followed by buccal mucosal grafting-in patients with subglottic and/or upper tracheal stenosis.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

性别: All
接受健康志愿者: 否

入选标准

•All consecutive patients with (grade II, III) subglottic and/or upper tracheal stenosis according to Myer-Cotton grading system
•all age groups (children and adults)

排除标准

•Patients with cervical spine diseases where an extended position during the procedure could be problematic.
•Previous neck or oral cavity irradiation.
•chronic uncontrolled debilitating diseases that might interfere with the healing process e.g. (diabetes mellitus, renal failure, decompensated liver diseases).

结局指标

主要结局

Airway diameter

时间窗: 3, 6, and 12 weeks

assessment of the diameter of the airway after the procedure by endoscopic examination

次要结局

subjective evaluation of breathing(3, 6, and 12 months)

研究者

发起方

Mansoura University

申办方类型

Other

责任方

Sponsor

研究点 (1)

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