Buccal Mucosal Graft for the Repair of Iatrogenic Pelviureteric Junction Obstruction or Ureteric Stricture.

Using Buccal Mucosal Graft as an Augmention Graft for Complex Cases of Iatrogenic Pelviureteric Junction Obstruction and Long Segment Ureteric Stricture Disease.

Prospective study to evaluate the safety and efficacy of using buccal mucosal graft for repairing complex cases of iatrogenic pelvi ureteric junction obstruction and long segment ureteric stricture disease.

Study Overview

• Status: Unknown
• Conditions: Pelvi Ureteric Junction Obstruction or Ureteral Stricture
• Intervention / Treatment: Procedure: buccal mucosal graft to repair iatrogenic PUJO

Detailed Description

A graft of buccal mucosa will be used to augment either the narrow unhealthy pelviureteric junction or a narrow long segment of the ureter.

after freeing the narrowed part, a posterior incision will be made in the ureter or renal pelvis then the graft will be implanted on the psoas muscle using interrupted sutures in a position the allows easy anastomosis to the ureter or renal pelvis.

Alternatively a lateral incision in the renal pelvis or the ureter may be done for the graft anastomosis and then surrounded with omenal flap to ensure a good blood supply for the graft.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- any patient with iatrogenic pelviureteric junction obstruction or long segment ureteric stricture

Exclusion Criteria:

• elderly patients unfit for general anaesthesia.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with iatrogenic PUJO; patients with iatrogenic PUJO or long segment ureteric stricture disease for safety and efficacy of using buccal graft for repair	Procedure: buccal mucosal graft to repair iatrogenic PUJO; Augmented buccal mucosal graft anastomosis to repair iatrogenic PUJO or long segment ureteric stricture disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with patent renal pelvis and ureter after surgery.	3 months after surgery Diuretic renography will be done to judge patency of the pelvis and ureter and resolution of hydronephrosis	3 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): August 7, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: cairo univeristy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: study protocol statistical analysis results
• IPD Sharing Time Frame: June 2021
• IPD Sharing Access Criteria: through clinical trials webpage
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No