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

October 13, 2018 updated by: Mohammed Aliaboeihayagan Ali Mohammed, Assiut University

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 .

Study Overview

Status

Unknown

Intervention / Treatment

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].

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

patients with failed anastomotic uretheroplasty for PFUDDI.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
2years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 20, 2018

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

October 1, 2017

First Submitted That Met QC Criteria

October 31, 2017

First Posted (Actual)

November 1, 2017

Study Record Updates

Last Update Posted (Actual)

October 16, 2018

Last Update Submitted That Met QC Criteria

October 13, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • failed urethroplasty

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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