Randomized Controlled Trial With a MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy - MOSAIC
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 10
- 主要终点
- Strictures
研究概览
简要总结
Cystectomy is the chosen treatment of bladder cancer in 400 cases every year in DK. In replacement of the removed bladder, a urinary diversion is constructed using 15cm of terminal ilium (Ad Modum Bricker).
Ureteral strictures are diagnosed in 15% of the cystectomized patients, and these patients are at increased risk of infections, loss of renal function and repeated interventions. The left ureter is diagnosed with 70% of all strictures, presumably due to the construction of the urinary diversion.
A modified urinary diversion have been tested in two small studies. The modified diversion is prolonged with 5cm compared to the conventional urinary diversion. The prolongation permits the urinary diversion to reach both the left and the right side of the abdomen, resulting in greater resection of non-viably distal ureter and less mobilization of the left ureter, lowering the rates of strictures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Bladder cancer with the indication for robot assisted radical cystectomy
- •Ileal conduit ad modum Bricker as planned urinary diversion
- •Ability to understand the participant information orally and in writing
- •Signed consent form
排除标准
- •Previous abdominal or pelvic radiotherapy
- •Previous major abdominal surgery involving resection of bowel or construction of an enteric stoma
- •Urostomy planned on the left side of the abdomen
- •Single kidney
- •Complete ureteral duplication (either uni- or bilaterally), known at time of inclusion
- •Pregnancy
结局指标
主要结局
Strictures
时间窗: Within 2 years after cystectomy
Number of participants with benign strictures in the left ureter
次要结局
未报告次要终点
研究者
Jørgen Bjerggaard Jensen
Professor, Consultant, MD, DMSc
Aarhus University Hospital