<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04503330</url>
  </required_header>
  <id_info>
    <org_study_id>cairo univeristy</org_study_id>
    <nct_id>NCT04503330</nct_id>
  </id_info>
  <brief_title>Buccal Mucosal Graft for the Repair of Iatrogenic Pelviureteric Junction Obstruction or Ureteric Stricture.</brief_title>
  <official_title>Using Buccal Mucosal Graft as an Augmention Graft for Complex Cases of Iatrogenic Pelviureteric Junction Obstruction and Long Segment Ureteric Stricture Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective study to evaluate the safety and efficacy of using buccal mucosal graft for&#xD;
      repairing complex cases of iatrogenic pelvi ureteric junction obstruction and long segment&#xD;
      ureteric stricture disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A graft of buccal mucosa will be used to augment either the narrow unhealthy pelviureteric&#xD;
      junction or a narrow long segment of the ureter.&#xD;
&#xD;
      after freeing the narrowed part, a posterior incision will be made in the ureter or renal&#xD;
      pelvis then the graft will be implanted on the psoas muscle using interrupted sutures in a&#xD;
      position the allows easy anastomosis to the ureter or renal pelvis.&#xD;
&#xD;
      Alternatively a lateral incision in the renal pelvis or the ureter may be done for the graft&#xD;
      anastomosis and then surrounded with omenal flap to ensure a good blood supply for the graft.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>20 patients with iatrogenic pelviureteric junction obstruction or ureteric stricture disease</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with patent renal pelvis and ureter after surgery.</measure>
    <time_frame>3 months</time_frame>
    <description>3 months after surgery Diuretic renography will be done to judge patency of the pelvis and ureter and resolution of hydronephrosis</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Pelvi Ureteric Junction Obstruction or Ureteral Stricture</condition>
  <arm_group>
    <arm_group_label>Patients with iatrogenic PUJO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with iatrogenic PUJO or long segment ureteric stricture disease for safety and efficacy of using buccal graft for repair</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>buccal mucosal graft to repair iatrogenic PUJO</intervention_name>
    <description>Augmented buccal mucosal graft anastomosis to repair iatrogenic PUJO or long segment ureteric stricture disease</description>
    <arm_group_label>Patients with iatrogenic PUJO</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - any patient with iatrogenic pelviureteric junction obstruction or long segment ureteric&#xD;
        stricture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  elderly patients unfit for general anaesthesia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Abozamel</investigator_full_name>
    <investigator_title>principal investigator urologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>study protocol statistical analysis results</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>June 2021</ipd_time_frame>
    <ipd_access_criteria>through clinical trials webpage</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04503330
org study id: cairo univeristy
nct id: NCT04503330
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: 20 patients with iatrogenic pelviureteric junction obstruction or ureteric stricture disease
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants with patent renal pelvis and ureter after surgery.
time frame: 3 months
description: 3 months after surgery Diuretic renography will be done to judge patency of the pelvis and ureter and resolution of hydronephrosis
arm group label: Patients with iatrogenic PUJO
arm group type: Experimental
description: patients with iatrogenic PUJO or long segment ureteric stricture disease for safety and efficacy of using buccal graft for repair
intervention type: Procedure
intervention name: buccal mucosal graft to repair iatrogenic PUJO
description: Augmented buccal mucosal graft anastomosis to repair iatrogenic PUJO or long segment ureteric stricture disease
arm group label: Patients with iatrogenic PUJO
criteria: 
gender: All
minimum age: N/A
maximum age: 60 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Abozamel
investigator title: principal investigator urologist
mesh term: Constriction, Pathologic
sharing ipd: Yes
ipd description: study protocol statistical analysis results
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: June 2021
ipd access criteria: through clinical trials webpage