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

Sponsor

Al-Azhar University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05928364

Collaborator

(none)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Stricture Ureter	Procedure: Buccal mucosa for proximal ureter stricture	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Patients with inclusion criteria of uretral stricture will be treated with open uretroplasty with buccal graft and omental wrappingPatients with inclusion criteria of uretral stricture will be treated with open uretroplasty with buccal graft and omental wrapping

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Buccal mucosa graft for ureteral stricture Patients with inclusion criteria of ureteral stricture will be treated with open ureteroplasty with buccal graft and omental wrapping.	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

Arm

Intervention/Treatment

Experimental: Buccal mucosa graft for ureteral stricture

Patients with inclusion criteria of ureteral stricture will be treated with open ureteroplasty with buccal graft and omental wrapping.

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

Outcome Measures

Primary Outcome Measures

Restoration of ureteric patency. [6 months post-operative]
Restoration of ureteric patency as assessed by contrast study (intravenous urography) and ureteroscope.

Secondary Outcome Measures

Pain relief after surgery [6 months post-operative]
Relief of pain measured by Visual Analog Score for pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urology department - AlAzhar university	Cairo		Egypt

Sponsors and Collaborators

Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Fawzy Abd Elfattah Salman, Director, Al-Azhar University

ClinicalTrials.gov Identifier:

NCT05928364

Other Study ID Numbers:

Buccal graft ureteroplasty

First Posted:

Jul 3, 2023

Last Update Posted:

Jul 3, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mohamed Fawzy Abd Elfattah Salman, Director, Al-Azhar University

Buccal mucosa

Stricture

ureteroplasty

Additional relevant MeSH terms:

Constriction, Pathologic

Study Results

No Results Posted as of Jul 3, 2023