临床试验/NCT07332585

NCT07332585已完成不适用

Efficacy of Piezosurgery Versus Conventional Osteotomy in Prelacrimal Approach Targeting Different Maxillary Sinus Pathologies: a Randomized Controlled Trial

Mansoura University1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2024年12月1日最近更新: 2026年1月12日

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Mansoura University
入组人数: 40
试验地点: 1
主要终点: Intraoperative bleeding

研究概览研究设计入排标准研究组 & 干预措施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

The prelacrimal recess approach is a minimally invasive approach to maxillary sinus lesions. The current study aimed to evaluate the efficacy of piezosurgery versus conventional osteotomy while performing a prelacrimal apporach.

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

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Any maxillary sinus pathology (recurrent Antrochoanal polyp, inverted papilloma, fungal ball, allergic fungal sinusitis, CRSwNP, CRSeNP, orbital floor fracture, etc).
•Favorable prelacrimal recess (Type II or III Simmen classification)
•Age> 18 years.
•No gender limitation.

排除标准

•patients with malignant sino-nasal tumors.
•patients unfit for surgery

研究组 & 干预措施

piezosurgery group

Active Comparator

干预措施: piezo-assisted prelacrimal apporach (Procedure)

conventional osteotomy group

Active Comparator

干预措施: conventional osteotomy prelacrimal approach (Procedure)

结局指标

主要结局

Intraoperative bleeding

时间窗: During the surgical procedure

The amount of blood collected in the suction device

Operative time

时间窗: During the surgical procedure

the time of surgical procedure

次要结局

Postoperative hyposthesia(six months after surgery)

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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