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临床试验/NCT07408050
NCT07408050Enrolling By Invitation不适用

A Study on the Reconstruction of Complex Ureteral Stenosis Utilizing Preputial Grafts.

Ruibao chen1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年8月3日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
50
试验地点
1
主要终点
Ureteral patency

研究概览

简要总结

Complex ureteral stricture refers to a ureteral lumen stenosis lesion that cannot be directly treated with the traditional end-to-end anastomosis. In recent years, its incidence has shown a gradual upward trend, and it has long been a major clinical challenge for urological surgeons. Because it is difficult to achieve tension-free anastomosis after direct resection of the strictured segment, which can easily lead to the failure of stricture repair surgery, simple ureteral stricture segment resection combined with end-to-end anastomosis is generally not recommended for the treatment of such diseases.

In general, clinicians need to select alternative materials for ureteral reconstruction, such as Boari flap, appendix, intestinal tract, and oral mucosa, to achieve the surgical effect of tension-free anastomosis. However, in some complex clinical cases, if Boari flap, appendix, intestinal tract or oral mucosa cannot be used for surgery, or if patients refuse to accept oral mucosa, intestinal mucosa and other tissues for ureteral repair, are there any other alternative schemes with high safety and minimal invasiveness available for ureteral reconstruction in clinical practice? Thus, it is of great clinical significance to develop safe, effective and innovative surgical techniques for ureteral reconstruction. Circumcision is a surgical procedure with a long history and wide application, and the prepuce removed during the operation is usually treated as medical waste. Our research team has previously performed a large number of surgeries using prepuce to repair the urethra. Clinical results have shown that free prepuce has the advantages of easy survival, convenient harvesting and minimal invasiveness, making it an ideal graft material for urinary tract repair and reconstruction.

At present, there have been case reports on ureteral reconstruction using prepuce abroad. Based on our team's previous research experience in the fields of urethral reconstruction and ureteral reconstruction, the investigators intend to carry out relevant research on ureteral reconstruction with free preputial grafts, aiming to obtain convincing clinical data and provide a more minimally invasive and safer new treatment option for the repair and reconstruction of complex ureteral strictures.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male patients over 18 years of age.
  • Preoperative assessment confirming complex ureteral strictures, characterized by ureteral luminal stenosis that cannot be addressed via conventional end-to-end anastomosis. Patients were deemed ineligible for existing surgical. interventions such as pyeloureteroplasty, ureteral end-to-end anastomosis, and ureteroneocystostomy.
  • Ability to undergo minimally invasive laparoscopic surgery for ureteral stricture repair.
  • Presence of redundant prepuce or availability of an inner preputial flap for graft harvesting.
  • Capacity for independent decision-making and willingness to voluntarily sign the informed consent form for study participation.

排除标准

  • Presence of surgical contraindications.
  • History of abdominal radiotherapy.
  • Ureteral strictures resulting from malignant tumors.
  • An Eastern Cooperative Oncology Group (ECOG) performance status score greater than
  • Poor compliance or other exclusion criteria as determined by the investigators.

研究组 & 干预措施

Patients with complex ureteral stenosis undergoing PGU surgery

Experimental

After enrolling patients with complex ureteral stenosis, PGU surgery was performed, and postoperative follow-up was conducted to assess complications, renal hydronephrosis, and renal function recovery.

干预措施: Preputial graft ureteroplasty (Procedure)

结局指标

主要结局

Ureteral patency

时间窗: From surgery to 6 months after surgery

The alteration in eGFR, denoted as ΔeGFR, was employed to evaluate changes in renal function. The calculation for ΔeGFR is as follows: ΔeGFR = (postoperative eGFR - preoperative eGFR) / preoperative eGFR. Renal ultrasound, computed tomography (CT), and magnetic resonance urography (MRU) are utilized to measure the anteroposterior diameter (APD) and indirectly assess ureteral patency.

次要结局

未报告次要终点

研究者

发起方
Ruibao chen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ruibao chen

Principal Investigator

Tongji Hospital

研究点 (1)

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