Transurethral En Bloc Resection With Collins Loop vs Conventional Transurethral Resection for the Treatment of Urothelial Bladder Carcinoma
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- presence of detrusor muscle in the resected sample
研究概览
简要总结
This is a prospective, randomized, randomized and single-blind study in patients diagnosed with primary bladder CV. Patients diagnosed by cystoscopy of a bladder tumor and with indication for endoscopic surgical treatment, who meet the inclusion criteria, and who sign the Informed Consent (IC), will be randomized.
详细描述
The main objective of the study is to assess the quality of the resection, defined as the presence of detrusor muscle in the resected tissue.
The secondary objetives are:
- Compare the surgical time, hospital stay, urinary catheterization time and incidence of complications.
- Compare tumor recurrence after one year of follow up.
- Determine the number of re-TURB as a consequence of the absence of muscle layer in the sample or artifacts (Tx)
- Establish the incidence of conversions as a consequence of difficulties in the technique or intraoperative bleeding.
- Compare the degree of satisfaction of the surgeon
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years old.
- •Polypoid / sessile primary tumor.
- •< 3 tumors
- •Tumor size 10 - 30 mm.
排除标准
- •> 4 tumors
- •Size of the largest tumor <1 cm and> 4 cm.
- •Tumor located in the bladder dome.
- •No visualization of the ureteral meatus.
- •Flat or in situ tumor.
- •Non-urothelial tumors.
- •Clotting disorder or treatment with oral anticoagulants.
研究组 & 干预措施
En Bloc TURBT with Collins Loop
If the patient is randomized to the TURB group, it will be carried out with a Collins loop, with bipolar energy.
After randomization, demographic data (age, sex, exposure to tobacco, occupational risk), symptoms prior to randomization (micro or macrohematuria, LUTS) and laboratory data (urinary cytology, hemoglobin and serum creatinine) will be collected. Finally, the physical characteristics of the lesion will be noted in the cystoscopy immediately prior to the intervention: size, location (s) and appearance of the tumor. After the intervention, the type of procedure (TURB / TUB), the duration of the procedure from when the resector is inserted until the urinary catheter is placed, and complications according to the Clavien-Dindo scale will be recorded. In your first post-surgical check-up, the days of hospital stay and the time of bladder catheterization will be collected.
干预措施: En bloc TURBT Collins Loop (Device)
Conventional TURBT
The TURB will be carried out with bipolar current according to the traditional technique.
干预措施: Conventional TURBT (Device)
结局指标
主要结局
presence of detrusor muscle in the resected sample
时间窗: 1 year of follow up
yes/no
次要结局
未报告次要终点
研究者
Berta Nasarre
Attending Physician
Hospital Universitario de Fuenlabrada