Holmium Versus Bipolar en Bloc Transurethral Resection of Urothelium Tumor of the Urinary Bladder: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- number of participant with Conversion to the TURBT
研究概览
简要总结
En bloc resection of bladder tumors (ERBT) may improve staging quality and perioperative morbidity and influence tumour recurrence
详细描述
Modern laser technology has led to new alternatives to conventional TURBT (cTURBT). The advocates of ERBT have three goals: to improve resection quality, lower perioperative complication rates, and decrease recurrence rates at resection sites. The present study is the first to compare the results of laser and electric en bloc resection of bladder cancer with respect to the aforementioned goals.
the investigators aim to compare the clinical outcome in the form of safety and efficacy between Holmium and bipolar transurethral en bloc resection of urinary bladder tumors.
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)
盲法说明
Patients will be blinded to the type of intervention as well as the data collector and the statistician.
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
- •Adult patients of both sexes presented with urinary bladder tumor aiming for complete resection as diagnosed by Ultrasound with or without CT prior histopathological assessment.
排除标准
- •Patients with signs of extravesical tumor extension where complete resection will not beneficial or unable to proceed to complete resection due to huge tumor burden either huge single tumor more than 5 cm or multiple tumors that are not candidate for complete resection.
结局指标
主要结局
number of participant with Conversion to the TURBT
时间窗: intraoperative finding
conversion from the enbloc way of resection to the standard trans-urethral resection of bladder tumors
次要结局
- hematuria(postoperative complication up to 2 weeks)
- Operative time(intraoperative finding)
- Presence of detrusor muscle in resected sample(one day after surgery during pathological evaluation)
- Resected specimen's edge(one day after surgery during pathological evaluation)
- intraoperative complication: bladder perforation(intraoperative)
- Incidence of obturator reflex(intraoperative)
- Post-operative catheterization time in hours(postoperative complication up to 2 weeks)
- Postoperative irrigation time in hours(postoperative in hours maximum 1 day)
- Recurrence rate of tumors according to time interval(1 year)
- Recurrence rate of tumors according to tumor location(1 year)
研究者
Ahmed Maher Gamil Ahmed Higazy
Assistant lecturer
Ain Shams University