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

• Sponsor: Cairo University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04503330
• Collaborator: (none)
• Enrollment: 20
• Arm: 1
• Anticipated Duration (Months): 14

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvi Ureteric Junction Obstruction or Ureteral Stricture	Procedure: buccal mucosal graft to repair iatrogenic PUJO	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: 20 patients with iatrogenic pelviureteric junction obstruction or ureteric stricture disease20 patients with iatrogenic pelviureteric junction obstruction or ureteric stricture disease
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Using Buccal Mucosal Graft as an Augmention Graft for Complex Cases of Iatrogenic Pelviureteric Junction Obstruction and Long Segment Ureteric Stricture Disease.
• Anticipated Study Start Date: Oct 1, 2020
• Anticipated Primary Completion Date: Nov 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Participants with patent renal pelvis and ureter after surgery. [3 months]

   3 months after surgery Diuretic renography will be done to judge patency of the pelvis and ureter and resolution of hydronephrosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• elderly patients unfit for general anaesthesia.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Abozamel, principal investigator urologist, Cairo University
• ClinicalTrials.gov Identifier: NCT04503330
• Other Study ID Numbers: cairo univeristy
• First Posted: Aug 7, 2020
• Last Update Posted: Aug 7, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Constriction, Pathologic

Study Results

No Results Posted as of Aug 7, 2020