Pelvi Ureteric Junction Obstruction or Ureteral StrictureNCT04503330
Buccal Mucosal Graft for the Repair of Iatrogenic Pelviureteric Junction Obstruction or Ureteric Stricture.
A study testing buccal mucosal graft to repair iatrogenic PUJO in people with Pelvi Ureteric Junction Obstruction or Ureteral Stricture, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Pelvi Ureteric Junction Obstruction or Ureteral Stricture
- What is being tested?
- buccal mucosal graft to repair iatrogenic PUJO
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- any patient with iatrogenic pelviureteric junction obstruction or long segment ureteric stricture
Who cannot join
- elderly patients unfit for general anaesthesia.
About this study
Official title: 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.
Read the 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.
- Being tested
- buccal mucosal graft to repair iatrogenic PUJO
- Medical subject headings
- Multicystic renal dysplasia, bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buccal mucosal graft to repair iatrogenic PUJOProcedure or surgery
Augmented buccal mucosal graft anastomosis to repair iatrogenic PUJO or long segment ureteric stricture disease
| Study group | Role | What they receive |
|---|---|---|
| Patients with iatrogenic PUJO | Experimental | patients with iatrogenic PUJO or long segment ureteric stricture disease for safety and efficacy of using buccal graft for repair Receives: Procedure: buccal mucosal graft to repair iatrogenic PUJO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvi Ureteric Junction Obstruction or Ureteral StrictureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 20 patients with iatrogenic pelviureteric junction obstruction or ureteric stricture disease
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abozamel, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503330
- Sponsor's protocol ID
- cairo univeristy
- Status last verified
- Aug 2020
- First submitted
- 3 Aug 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol statistical analysis results
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Buccal Mucosal Graft as an Augmention Graft for Complex Cases of Iatrogenic Pelviureteric Junction Obstruction and Long Segment Ureteric Stricture Disease.
- ClinicalTrials.gov ID
- NCT04503330
- Acronym / sponsor ID
- cairo univeristy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 20 patients with iatrogenic pelviureteric junction obstruction or ureteric stricture disease
| Arm | Type | Receives |
|---|---|---|
| Patients with iatrogenic PUJO | Experimental | Procedure: buccal mucosal graft to repair iatrogenic PUJOpatients with iatrogenic PUJO or long segment ureteric stricture disease for safety and efficacy of using buccal graft for repair |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- any patient with iatrogenic pelviureteric junction obstruction or long segment ureteric stricture
Key exclusion criteria (1 listed)
- elderly patients unfit for general anaesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| buccal mucosal graft to repair iatrogenic PUJOAugmented buccal mucosal graft anastomosis to repair iatrogenic PUJO or long segment ureteric stricture disease | Procedure or surgery | Patients with iatrogenic PUJO |
Primary outcome
Number of Participants with patent renal pelvis and ureter after surgery.
Time frame: 3 months
3 months after surgery Diuretic renography will be done to judge patency of the pelvis and ureter and resolution of hydronephrosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Individual participant dataSharing planned: Yes. study protocol statistical analysis results
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing buccal mucosal graft to repair iatrogenic PUJO in people with Pelvi Ureteric Junction Obstruction or Ureteral Stricture, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with patent renal pelvis and ureter after surgery. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.