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临床试验/NCT06783855
NCT06783855招募中不适用

Outcomes of Uretheroileal Suspension Technique During Open Radical Cystectomy and Ileal Neobladder: A Prospective Randomized Comparative Study

Sohag University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
The continence rates at 1, 3, 6 and 12 months after the procedure will be evaluated

研究概览

简要总结

The suspension technique is reported as the puboprostatic ligaments that attach the prostate to the symphysis pubis. After the ligating the complex, including both the dorsal vein complex and the puboprostatic ligaments, this complex was sharply divided anteriorly from the prostate with a safe distance (1-2 mm), and the urethra is defined and divided. After removing the prostate, the ileal pouch is reconstructed by completely everting the mucosa and sutured outward with a running 4-0 absorbable suture around the edge. The neck of the neobladder was narrowed to ≈1 cm, for convenient passage of a 20 F catheter. Anastomotic sutures of 3-0 absorbable polyglactin were placed at the 1, 3, 5, 6, 7, 9, 11 and 12 o'clock positions

详细描述

The suspension technique is reported as the puboprostatic ligaments that attach the prostate to the symphysis pubis. After the ligating the complex, including both the dorsal vein complex and the puboprostatic ligaments, this complex was sharply divided anteriorly from the prostate with a safe distance (1-2 mm), and the urethra is defined and divided. After removing the prostate, the ileal pouch is reconstructed by completely everting the mucosa and sutured outward with a running 4-0 absorbable suture around the edge. The neck of the neobladder was narrowed to ≈1 cm, for convenient passage of a 20 F catheter. Anastomotic sutures of 3-0 absorbable polyglactin were placed at the 1, 3, 5, 6, 7, 9, 11 and 12 o'clock positions through the full thickness of the urethra, including the mucosa and muscularis of the neobladder neck, ensuring mucosa-to-mucosa anastomosis. The sutures at the 1 and 11 o'clock positions were anchored to the ligated complex including both the dorsal vein complex and the puboprostatic ligaments, to suspend the poucho-urethral anastomosis (suspension technique). The difference between the suspension and no-suspension techniques is only the placing of two sutures into the ligated complex

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient age >18 years.
  • •Muscle-invasive bladder carcinoma (MIBC).
  • •Non-muscle-invasive bladder carcinoma (NMIBC) fulfilling the following criteria:
  • •(recurrent disease that is unresponsive to other treatments
  • •high-grade tumors (T1, carcinoma in situ) refractory to intravesical therapy
  • •Multifocal or recurrent high-grade tumors despite intravesical therapy and the tumor progression from NMIBC to MIBC).

排除标准

  • •NMIBC or benign disease.
  • •Severe hepatic renal dysfunction.
  • •Urethral involvement with bladder carcinoma.
  • •Poor overall health status.
  • •Severe renal dysfunction.

研究组 & 干预措施

: group (A) 30 patients will be treated with suspension uretheroileal technique

Active Comparator

干预措施: suspension uretheroileal technique (Procedure)

group (B) 30 patients will be treated with conventional radical cystectomy and ileal neobladder

Active Comparator

干预措施: conventional radical cystectomy and ileal neobladder (Procedure)

结局指标

主要结局

The continence rates at 1, 3, 6 and 12 months after the procedure will be evaluated

时间窗: at 1, 3, 6 and 12 months after the procedure will be evaluated

Urinary continence after urethroileal suspension technique

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 Mohamed Abdellah

assistant lecturer urology department sohag university hospital

Sohag University

研究点 (1)

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