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Failed Anastomotic UrethroplastyNCT03328000

Radiological Re-evaluation of Failed Anastomotic Uretheroplasty for PFUDDI Using Computed Tomographic Urethrography.

An observational study of Failed Anastomotic Urethroplasty, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Estate vlue of CTU in evaluation of failed anastomotic urethroplasty for pelvic fracture urethral distraction defect injury [PFUDDI] combared to retrograde urethrography and voiding cysto-urethrography . Read more about this study

Who is it for?
Any age, men only
Conditions the study is for
Failed Anastomotic Urethroplasty
What is being tested?
CTU and MR urethrography
Type of treatment
Surgery or procedure
How many people
20 participants
Where
No sites listed yet
Study dates
20 Oct 2018to Apr 2019
Phase
Observational
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 Any age
  • Men only
  • Child, Adult, Older adult

Study population: patients with failed anastomotic uretheroplasty for PFUDDI.

Who may be able to join

  • 1-patient with normal bladder. 2-Patient with fructure pelvis.

Who cannot join

  • 1-Patient without fracture pelvis. 2-Patient with other pathology as neurogenic bladder.

Trial locations and contacts

No sites are listed yet.

Mohammed Aliaboelhayagan Ali contact

+208801013002681

aboali199117@yahoo.com

About this study

Official title: Radiological Re-evaluation of Failed Anastomotic Uretheroplasty for PFUDDI Using Computed Tomographic Urethrography

Estate vlue of CTU in evaluation of failed anastomotic urethroplasty for pelvic fracture urethral distraction defect injury [PFUDDI] combared to retrograde urethrography and voiding cysto-urethrography .

Read the detailed description

Blunt pelvic trauma results in posterior urethral distraction defects (PUDDs) in ª10% of cases; such injury commonly involves the membranous urethra at the point of departure from the bulbospongiosum, at the prostatomembranous junction, or at any point between its departure and the apex of the prostate [1]. PUDDs are complex pathologically, involving displacement and misalignment of the severed urethral ends with intervening and surrounding fibrosis. Detached bony fragments and callus formation add to the pathological complexity. For a successful repair of a PUDD it is necessary to identify the specific anatomy of the distraction defect before undertaking any treatment[2].

Currently most PFUDDI are associated with trauma as an etiology. Posterior urethral disruption occurs in 4-14% of pelvic ring fractures and 80-90% of posterior urethral injuries are associated with pelvic fractures[4]. Sixty-five percent of post-traumatic posterior urethral injuries are complete[5]. Following trauma the ruptured urethra is usually replaced by fibrosis and in between there is no lumen. Anastomotic urethroplasty is a well established procedure to deal with posterior urethral strictures and gives very good long-term results[6,7].

The success rate of repeat surgery for failed urethroplasty is reported to be less than that for primary urethroplasty. Jakse et al;reported a 71% failure rate following end-to-end urethroplasty with a history of prior urethroplasty[8].

The success rate of end-to-end anastomosis varies from 77 to 95% as described by different series[9,10,11,12]There are very few reports regarding urethroplasty for previously failed PFUDDI[13,14],The most common causes of failure of urethroplasty are the inadequate excision of the strictured segment and surrounding fibrosis, improper case selection and ischemia[14].

For a successful repair of a PFUDDI it is necessary to identify the specific anatomy of the distraction defect before undertaking any treatment, The classic approach for evaluating a PFUDDI is through Retrograde Urethrography [RUG] and Voiding cysto-urethrography (VCUG), particularly while the patient is attempting to void. However, this study can often give a false interpretation of the exact anatomy of the distraction defect on many occasions[15].

It often cannot provide an accurate determination of the defect length because of poor prostatic urethral filling and it provides little information on the extent of corpus spongiosal fibrosis or prostatic displacement[15].

CTCUG was more informative than conventional radiology in several aspects; the location and the length of the distraction defect; the direction of alignment or misalignment; the bone anatomy (ectopic fragments, callus); and the presence of additional urinary pathology (fistulae, false passages, diverticulae)[2].

Being tested
CTU and MR urethrography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CTU and MR urethrographyRadiation

    computed tomographic and Magnetic Resonance Urethrography.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of failed anastomotic urethroplasty for pelvic fracture urethral distraction defect injury[PFUDDI], Measurement of the actual length and location of the defect.and detection of bony abnormality as fragment affecting the healing process.

    Patient with failed anastmotic urethroplasty will undergo CTU to show if they will provide more data about the anatomy of the defect including lenth degree of the fibrosis pelvic blood supply and presence of bone defect affecting healing or any other finding can not be evaluated by other diagnostic measures.

    Measured: 2years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2017
  2. Study start20 Oct 2018 (estimated)
  3. Primary completionMar 2019 (estimated)
  4. Study completionApr 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03328000
Sponsor's protocol ID
failed urethroplasty
Status last verified
Oct 2018
First submitted
1 Oct 2017
Last updated
16 Oct 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Failed Anastomotic Urethroplasty, run by Assiut 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 16 Oct 2018. 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?

Contact Mohammed Aliaboelhayagan Ali (+208801013002681, aboali199117@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of failed anastomotic urethroplasty for pelvic fracture urethral distraction defect injury[PFUDDI], Measurement of the actual length and location of the defect.and detection of bony abnormality as fragment affecting the healing process. (time frame: 2years). 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 16 Oct 2018.

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