An Investigation Into the Application of Preputial Grafts for the Reconstruction of Complex Ureteral Strictures

Официальное название

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

Обзор

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.

Вмешательства

• Процедура Preputial graft ureteroplasty
  Reconstruction of complex ureteral stenosis using preputial graft

Первичные конечные точки

• Ureteral patency [Срок оценки: From surgery to 6 months after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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 2.
• Poor compliance or other exclusion criteria as determined by the investigators.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань

Идентификаторы

NCT: NCT07408050 · TJ-IRB202505033 · MR-42-25-056915

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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