Buccal Mucosal Graft for Onlay Ureteroplasty in the Manag... | NCT05928364

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

NCT05928364

Sponsor

Al-Azhar University

Status

Recruiting

Last Update Posted

Aug 15, 2024Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Stricture Ureter

Interventions

Buccal mucosa for proximal ureter stricture

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Sep 11, 2024Estimated

Completion Date

Oct 1, 2024Estimated

First Submitted Date

May 22, 2023

First Submission Date that Met QC Criteria

Jun 23, 2023

First Posted Date

Jul 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2024

Last Update Posted Date

Aug 15, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed Fawzy Abd Elfattah Salman, Director, Al-Azhar UniversityPrincipal Investigator

Lead Sponsor

Al-Azhar UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Buccal mucosa graft for ureteral stricture	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Buccal mucosa for proximal ureter stricture	Procedure	Patients with inclusion criteria of uretral stricture will be treated with open uretroplasty with buccal graft and omental wrapping

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed F Salman, MD	Contact	+201111788996		prof_mohamed_fawzy@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Urology department - AlAzhar university	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003251	Constriction, Pathologic

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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