Holmium Laser En-Bloc Resection Versus Conventional Transurethral Resection of Bladder Tumors for Treatment of Non-muscle- Invasive Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Presence of Detrusor Muscle in Resected Specimen
研究概览
简要总结
This study is a prospective randomized controlled trial comparing holmium laser en-bloc resection of bladder tumor (HoLERBT) with conventional transurethral resection of bladder tumor (cTURBT) in patients with suspected non-muscle-invasive bladder cancer (NMIBC).
A total of 100 patients will be randomly assigned in a 1:1 ratio to undergo either HoLERBT or cTURBT. The primary outcome is the quality of the pathological specimen, assessed by the presence of detrusor muscle. Secondary outcomes include perioperative complications, operative time, obturator nerve reflex, bladder perforation, positive surgical margins, persistent disease at second-look TURBT, and recurrence rates at 3 and 12 months, as well as recurrence-free survival.
This study aims to evaluate whether HoLERBT provides superior resection quality and improved clinical outcomes compared to conventional TURBT.
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
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 30 years or older.
- •Patients with cystoscopically suspected primary NMIBC planned for endoscopic resection.
- •Fit for surgery and anesthesia.
- •Able and willing to provide written informed consent and comply with follow-up.
排除标准
- •Muscle-invasive disease suspected preoperatively or evidence of metastatic disease.
- •Prior bladder radiotherapy.
- •Severe comorbidity precluding surgery.
- •Pregnancy.
- •Inability to provide informed consent.
- •Upper urinary tract urothelial carcinoma or life expectancy less than 1 year
研究组 & 干预措施
Holmium Laser En-Bloc Resection (HoLERBT)
Patients in this group will undergo holmium laser en-bloc resection of bladder tumor (HoLERBT). The procedure involves complete tumor excision in a single piece using a holmium laser, allowing improved specimen quality and better hemostasis.
干预措施: Holmium Laser En-Bloc Resection of Bladder Tumor (Procedure)
Conventional TURBT
Patients in this group will undergo conventional transurethral resection of bladder tumor (cTURBT), performed using standard resection techniques with a monopolar or bipolar resectoscope.
干预措施: Conventional Transurethral Resection of Bladder Tumor (Procedure)
结局指标
主要结局
Presence of Detrusor Muscle in Resected Specimen
时间窗: Immediately after surgery (postoperative histopathological assessment)
Assessment of the quality of tumor resection based on the presence of detrusor muscle in the histopathological specimen obtained after surgery.
次要结局
- Intraoperative Complications(During surgery)
- Tumor Recurrence at 3 Months(3 months after surgery)
研究者
Mahmoud Abdallah
lecturer of urology
Beni-Suef University