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

NCT07408050 | Not Yet Recruiting DMC

• 2 other identifiers: TJ-IRB202505033MR-42-25-056915
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ureteral Stenosis

Outcome Measures

Primary Outcomes (1)

• Ureteral patency

  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.

  From surgery to 6 months after surgery

Study Arms (1)

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.

Procedure: Preputial graft ureteroplasty

Interventions

Preputial graft ureteroplasty PROCEDURE

Reconstruction of complex ureteral stenosis using preputial graft

Patients with complex ureteral stenosis undergoing PGU surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruibao chen: lead

Central Study Contacts

Ruibao chen, Dr

CONTACT

08602769378205; rbchen@tjh.tjmu.edu.cn

Xiaoyong Zeng, Dr

CONTACT

08602769378215

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 12, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2032
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: From 20260206 to 20310101
• Access Criteria: ICMJE will be able to access the IPD and supporting information. They will be able to access Study Protocol,Statistical Analysis Plan, and Clinical Study Report.