Comparison Between En-Bloc Transurethral Resection Versus Conventional Transurethral Resection of Urinary Bladder Tumors From 2 to 6 cm in Size, Histopathological Findings.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- the presence of detrusor muscle in histopathologic specimens
研究概览
简要总结
This study is designed to determine whether en-bloc TURBT provides superior histopathological quality and clinical outcomes compared to conventional TURBT in medium-sized bladder tumors.
详细描述
This study is a prospective randomized clinical trial conducted at Ain Shams University to compare en-bloc transurethral resection (ERBT) with conventional transurethral resection (TURBT) for urinary bladder tumors sized 2-6 cm. The primary endpoint is the presence of detrusor muscle in histopathological specimens, while secondary outcomes include bladder perforation, residual disease at second TURBT, margin status, operation time, obturator reflex, and conversion rates. By focusing on specimen integrity and surgical efficacy, the study aims to determine whether en-bloc TURBT provides superior diagnostic accuracy and clinical outcomes compared to the conventional approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •Tumor diameter of 2-6 cm
- •Patients fit for spinal or general anesthesia
排除标准
- •recurrent bladder tumours.
- •concomitant urothelial cancer of the upper urinary tract
- •metastatic bladder cancer
研究组 & 干预措施
Group A: Underwent En bloc Bipolar TURBT
干预措施: En bloc TURBT using a bipolar Karl-Storz resectoscope system fitted with a specialized "flat" resection loop (Procedure)
Group B: Bipolar piecemeal TURBT
干预措施: Bipolar piecemeal TURBT using the same bipolar Karl-Storz resectoscopic platform (Procedure)
结局指标
主要结局
the presence of detrusor muscle in histopathologic specimens
时间窗: 10 days post TURBT
This assessment aims to compare the histopathological outcomes between the tumors obtained from the en bloc bipolar resection versus the conventional method bipolar Trans-Urethral Resection of Bladder Tumor techniques
次要结局
未报告次要终点
研究者
Younan Ramsis
Lecturer of Urology
Ain Shams University