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临床试验/NCT05673044
NCT05673044尚未招募不适用

Functional Evaluation of Modified Studer and Modified Spiral Orthotopic Ileal Neobladders After Radical Cystectomy.

Assiut University2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年1月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdelrahman Atef Ali

Assistant lecturer of Urology Assuit University Hospital

Assiut University

研究点 (2)

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