Functional Evaluation of Modified Studer and Modified Spiral Orthotopic Ileal Neobladders After Radical Cystectomy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- The assessment of the reservoir capacity
研究概览
简要总结
Bladder cancer is the most common malignant neoplasm of the urinary system. Neoadjuvant chemotherapy followed by radical cystectomy (RC) is the standard treatment for Muscle invasive bladder cancer.
Studer neobladder is one of the commonly used techniques for orthotopic reconstruction, originally utilizing 60-65 cm of the ileum. However, this leads to formation of a flaccid reservoir.
Nowadays, most techniques use 40-45 cm ileal segment only due to the proven increased reservoir capacity over time. So Moeen et al developed a modified Studer ileal neobladder by using a shorter ileal segment (40 cm only).
Upper urinary tract protection is important in neobladder reconstruction. One of the proposed anti-reflux techniques is using an isoperistaltic limp which was about 20 cm. This segment will be compressed by the elevated intra-abdominal pressure during Valsalva voiding to prevent reflux. However, this length was subjected to multiple reductions in multiple studies. Moeen et al used an 8 cm straight isoperistaltic ileal chimney.
In spiral neobladder the ureters are implanted into the reservoir using a non-refluxing split-cuff nipple technique. It has good functional and urodynamic parameters. Moeen et al added 8 cm as RT sided angled chimney over the neobladder. The ureters were implanted directly in an end to side manner. They assumed that adding this angulation to this short chimney decreases reflux and protect the UUT, without adding time to develop an anti-reflux technique.
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, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with muscle invasive bladder cancer (T2-3N0-1M0).
- •Patients with T1 high grade bladder cancer with failed intravesical immunotherapy.
- •Bladder neck area including the trigone free from cancerous involvement.
- •Patients accepting the operation who are medically fit.
排除标准
- •Patients with serum creatinine ≥ 1.8 mg/dl.
- •Patients with intestinal disorders including previous bowel resections, severe diverticulosis or inflammatory bowel disease.
- •Inability to do perform clean intermittent catheterization (CIC) due to physical or mental impairment.
- •Sphincteric deficiency or urethral stricture disease causing voiding dysfunction.
- •Positive prostatic urethral biopsy.
结局指标
主要结局
The assessment of the reservoir capacity
时间窗: At 12th month post operative
Assessment of reservoir capacity by pouch size in urodynamics
次要结局
未报告次要终点
研究者
Abdelrahman Atef Ali
Assistant lecturer of Urology Assuit University Hospital
Assiut University
