CClinicalTrials.gg
Status unknownNCT03328000Updated Oct 16, 2018

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

An observational study in Failed Anastomotic Urethroplasty, sponsored by Assiut University. Status unknown. Open to male participants. Per ClinicalTrials.gov, last updated 2018-10-16.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Sex
Male
01

Study 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 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].

02

Conditions studied

  • Failed Anastomotic Urethroplasty
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Sampling method
Non-probability sample

Study population

patients with failed anastomotic uretheroplasty for PFUDDI.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 1-Patient without fracture pelvis. 2-Patient with other pathology as neurogenic bladder.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Interventions

  • RadiationCTU and MR urethrography

    computed tomographic and Magnetic Resonance Urethrography.

05

What researchers measure

Primary outcomes

  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.

    Time frame: 2years

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03328000
Lead sponsor
Assiut University
Responsible party
Mohammed Aliaboeihayagan Ali Mohammed (resident doctor, Assiut University) — Principal investigator
First posted
Nov 1, 2017
Start date
Oct 20, 2018 (estimated)
Primary completion
Mar 2019 (estimated)
Completion
Apr 2019 (estimated)
Last update
Oct 16, 2018

Study contacts

Mohammed Aliaboelhayagan Ali
Contact
aboali199117@yahoo.com
+208801013002681

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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