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NCT Number: NCT07408050

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

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Preputial graft ureteroplasty

Procedure

Reconstruction of complex ureteral stenosis using preputial graft

Primary outcomes

  1. Ureteral patency

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ruibao chen, Dr

CONTACT

[email protected]

08602769378205

Xiaoyong Zeng, Dr

CONTACT

08602769378215

Sponsors and collaborators

Lead sponsor

Ruibao chen

Other

Registry information

Official study title

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

Acronym: PGU20240101

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Feb 12, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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