跳至主要内容
临床试验/NCT06912945
NCT06912945Enrolling By Invitation不适用

Factors Affecting the Outcomes of Using the Diode Laser in Benign Laryngeal Lesions

Sohag University1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2024年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
108
试验地点
1
主要终点
change in voice handicap index Arabic version (VHI-Arabic)

研究概览

简要总结

Studying the different Factors affecting the outcomes of using diode laser both 980 nm wave length and 450 wavelength on benign laryngeal lesions in comparison to traditional cold instrumentations

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
Double (Participant, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •All patients with benign laryngeal lesions

排除标准

  • •patients presenting with or have history of malignant laryngeal lesion

研究组 & 干预措施

Group (A)

Active Comparator

using diode laser 980nm wavelength in benign laryngeal lesions

干预措施: using diode laser 980nm wavelength in benign laryngeal lesions (Procedure)

Group (B)

Active Comparator

using diode laser 450nm wavelength in benign laryngeal lesions

干预措施: using diode laser 450nm wavelength in benign laryngeal lesions (Procedure)

Group (C)

Active Comparator

using traditional cold instrumentations in benign laryngeal lesions

干预措施: using traditional cold instrumentations in benign laryngeal lesions (Procedure)

结局指标

主要结局

change in voice handicap index Arabic version (VHI-Arabic)

时间窗: 2 months after treatment

change in Voice handicap index Arabic version from baseline before treatment and after treatment

change in voice acoustic analysis

时间窗: 2 months after treatment

change in voice acoustic analysis including change in jitter and shimmer values from baseline preoperative and 2 months after treatment

change in voice handicap index Arabic version (VHI-Arabic)

时间窗: 2 months after treatment

change in Voice handicap index Arabic version from baseline before treatment and after treatment

change in voice acoustic analysis

时间窗: 2 months after treatment

change in voice acoustic analysis including change in jitter and shimmer values from baseline preoperative and 2 months after treatment

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

Mohamed Abdelsamei Abdelgalil

Assistant Lecturer of Otorhinolaryngology

Sohag University

研究点 (1)

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