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

June 23, 2023 updated by: Mohamed Fawzy Abd Elfattah Salman, Al-Azhar University
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Urology department - AlAzhar university
        • Contact:
        • Principal Investigator:
          • Mohamed F Salman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restoration of ureteric patency.
Time Frame: 6 months post-operative
Restoration of ureteric patency as assessed by contrast study (intravenous urography) and ureteroscope.
6 months post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relief after surgery
Time Frame: 6 months post-operative
Relief of pain measured by Visual Analog Score for pain
6 months post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

June 23, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Buccal graft ureteroplasty

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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