Buccal Mucosal Graft for Onlay Ureteroplasty in the Management of Proximal Ureteral Stricture

Stricture Ureter Clinical Trial

Official title:

Buccal Mucosal Graft for Onlay Ureteroplasty in the Management of Proximal Ureteral Stricture

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05928364
• Other study ID #: Buccal graft ureteroplasty
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: June 2023
• Source: Al-Azhar University
• Contact: Mohamed F Salman, MD
• Phone: +201111788996
• Email: prof_mohamed_fawzy[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Onlay uretroplasty with either grafts or flaps has been attempted by many reconstructive urologists, ln particular buccal mucosa graft (BMG) ureteroplasty has been reported by many centers and has shown its feasibility and safety

Description:

In cases of long segment upper ureteral stricture, more advanced surgical techniques, such as renal mobilization and downward nephropexy, ileal ureter replacement, transureteroureterostomy, and autotransplantation of the kidney, are necessary to provide a tension-free anastomosis.

Autotransplantation of the kidney needs more efforts, more experts and may lead to significant renovascular complications.

Also, there is severe metabolic and intestinal complications are associated with using of long intestinal segment in the management of ureteral stricture [9].

These previous side effects and difficulties make the management of long upper and middle ureteral strictures more complicated and indicate other lines of management urgently.

Even the ureteral stricture still not patent enough to drain urine but still, we can use it as a ureteral plate with little affection of its vascularity. Based on this theory an onlay repair technique was emerged.

Onlay uretroplasty with either grafts or flaps has been attempted by many reconstructive urologists, ln particular buccal mucosa graft (BMG) ureteroplasty has been reported by many centers and has shown its feasibility and safety.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Proximal ureteral stricture or uretropelvic junction obstruction (UPJO) which are not amenable for primery anastmosis.

Exclusion Criteria:

• Buccal graft contraindications as i. Active oral infections ii.Oral cancers like cancers of lips, tongue or cheeks.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Stricture Ureter

Intervention

Procedure:
• Buccal mucosa for proximal ureter stricture
Patients with inclusion criteria of uretral stricture will be treated with open uretroplasty with buccal graft and omental wrapping

Locations

Country	Name	City	State
Egypt	Urology department - AlAzhar university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Restoration of ureteric patency.	Restoration of ureteric patency as assessed by contrast study (intravenous urography) and ureteroscope.	6 months post-operative
Secondary	Pain relief after surgery	Relief of pain measured by Visual Analog Score for pain	6 months post-operative