Bipolar Enbloc Versus Thulium-Yag Enbloc Resection Of Bladder Tumors: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Blood loss
研究概览
简要总结
Prospective controlled study randomized comparing bipolar enbloc versus thulium enbloc for bladder tumours
详细描述
Bladder cancer is the ninth most prevalent cancer worldwide and the 2nd most common urologic cancer in the last two decades after cancer prostate .
Most bladder cancers attributed to exposure to environmental and occupational chemicals, the largest of which by far is tobacco smoke. Greater tobacco smoke and occupational exposure in men may help in the explanation of the 4-fold gender difference in bladder cancer incidence .
Approximately 75-85% of patients with bladder cancer present with disease confined to the mucosa or submucosa , which is referred to as nonmuscle invasive bladder cancer (NMIBC).
Transurethral resection of bladder tumor (TURBT) is still considered the gold standard treatment for primary nonmuscle invasive bladder cancer.
There are many drawbacks for conventional TURBT procedure such as such as the deficiency of the bladder detrusor muscle In the specimen
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
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Blood loss
时间窗: Immediate postoperative
Assessed by comparing between Hemoglobin level pre and post operative
Duration of cancer free survival post enbloc resection
时间窗: 1year
Duration of Cancer free survival post resection measured by weeks.
Staging of bladder cancer post enbloc resection
时间窗: 1year
Clinical staging using bimanual examination under anesthesia.
Presence of residual tumors post resection
时间窗: 3-6 months
Assessed by visualization of any residual mass during second look cystoscopy
Enbloc technique effectiveness in obtaining muscle in the speciment
时间窗: 3 months
Assessed by presence of muscles in histopathological specimen.
次要结局
未报告次要终点
研究者
Mohamed Kamal Omar
Associate professor of urology
Menoufia University