临床试验/NCT04839029

NCT04839029Unknown不适用

Bipolar Versus Monopolar Needlescopic En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer: A Prospective Randomized Study

Benha University1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2019年11月1日最近更新: 2022年7月19日

适应症

干预措施

试验速览

阶段: 不适用
发起方: Benha University
入组人数: 200
试验地点: 1
主要终点: Quality of tumor Resection

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

Non-muscle invasive bladder cancers (NMIBC) compose about 80% of bladder tumors. the stranded treatment of these tumors is TURBT.

en bloc resection of NMIBC yields better mascularis propria with better oncological outcomes

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

•confirmed primary NMIBC (Ta, Tis, T1)
•Age > 18 years

排除标准

•anterior located mass ( difficult or non visualized)

研究组 & 干预措施

Bipolar En bloc TURBT

Experimental

patient subjected to bipolar Needlescopic En bloc resection of NMIBC

干预措施: Bipolar En bloc TURBT (Procedure)

Monopolar En bloc TURBT

Active Comparator

patient subjected to Monopolar Needlescopic En bloc resection of NMIBC

干预措施: Monopolar En bloc TURBT (Procedure)

结局指标

主要结局

Quality of tumor Resection

时间窗: immediatly post operative

presence of detrusor muscle

adequacy of tumor Resection

时间窗: 2 to 6 weeks postoprative

Presence of residual tumor at the bed of previously resected NMIBC

次要结局

Complications(within 30 days post-operative)

研究者

发起方

Benha University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Waleed El-Shaer, MD

Associate professor

Benha University

研究点 (1)

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