Back to resultsBuccal Mucosal Graft for Onlay Ureteroplasty in the Management of Proximal Ureteral Stricture
Primary Purpose
Stricture Ureter
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Buccal mucosa for proximal ureter stricture
Sponsored by
About this trial
This is an interventional treatment trial for Stricture Ureter focused on measuring Buccal mucosa, Stricture, ureteroplasty
Eligibility Criteria
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.
Sites / Locations
- Urology department - AlAzhar universityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Buccal mucosa graft for ureteral stricture
Arm Description
Patients with inclusion criteria of ureteral stricture will be treated with open ureteroplasty with buccal graft and omental wrapping.
Outcomes
Primary Outcome Measures
Restoration of ureteric patency.
Restoration of ureteric patency as assessed by contrast study (intravenous urography) and ureteroscope.
Secondary Outcome Measures
Pain relief after surgery
Relief of pain measured by Visual Analog Score for pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05928364
Brief Title
Buccal Mucosal Graft for Onlay Ureteroplasty in the Management of Proximal Ureteral Stricture
Official Title
Buccal Mucosal Graft for Onlay Ureteroplasty in the Management of Proximal Ureteral Stricture
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stricture Ureter
Keywords
Buccal mucosa, Stricture, ureteroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients with inclusion criteria of uretral stricture will be treated with open uretroplasty with buccal graft and omental wrapping
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Buccal mucosa graft for ureteral stricture
Arm Type
Experimental
Arm Description
Patients with inclusion criteria of ureteral stricture will be treated with open ureteroplasty with buccal graft and omental wrapping.
Intervention Type
Procedure
Intervention Name(s)
Buccal mucosa for proximal ureter stricture
Intervention Description
Patients with inclusion criteria of uretral stricture will be treated with open uretroplasty with buccal graft and omental wrapping
Primary Outcome Measure Information:
Title
Restoration of ureteric patency.
Description
Restoration of ureteric patency as assessed by contrast study (intravenous urography) and ureteroscope.
Time Frame
6 months post-operative
Secondary Outcome Measure Information:
Title
Pain relief after surgery
Description
Relief of pain measured by Visual Analog Score for pain
Time Frame
6 months post-operative
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed F Salman, MD
Phone
+201111788996
Email
prof_mohamed_fawzy@yahoo.com
Facility Information:
Facility Name
Urology department - AlAzhar university
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed F Salman, MD
Phone
+201111788996
Email
Prof_mohamed_fawzy@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mohamed F Salman, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Buccal Mucosal Graft for Onlay Ureteroplasty in the Management of Proximal Ureteral Stricture
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