NCT05928364

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2024

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

2.7 years

First QC Date

May 22, 2023

Last Update Submit

August 13, 2024

Conditions

Stricture Ureter

Keywords

Buccal mucosaStrictureureteroplasty

Outcome Measures

Primary Outcomes (1)

  • Restoration of ureteric patency.

    Restoration of ureteric patency as assessed by contrast study (intravenous urography) and ureteroscope.

    6 months post-operative

Secondary Outcomes (1)

  • Pain relief after surgery

    6 months post-operative

Study Arms (1)

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

Buccal mucosa for proximal ureter stricturePROCEDURE

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

Buccal mucosa graft for ureteral stricture

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology department - AlAzhar university

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Mohamed F Salman, MD

CONTACT

+201111788996prof_mohamed_fawzy@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Patients with inclusion criteria of uretral stricture will be treated with open uretroplasty with buccal graft and omental wrapping
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 22, 2023

First Posted

July 3, 2023

Study Start

January 1, 2022

Primary Completion

September 11, 2024

Study Completion

October 1, 2024

Last Updated

August 15, 2024

Record last verified: 2024-08

Locations

EG(1)