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Trauma;PelvisNCT03533270

Urological Outcome of Posterior Urethroplasty in Patients in Assuit University

An observational study of Trauma;Pelvis, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The management of posterior urethral disruption secondary to blunt pelvic injury remains controversial. While many groups have recommended early realignment of urethral distraction injuries, Classic reports advocate a suprapubic cystostomy at the time of injury with delayed, perineal approach urethral re- construction… Read more about this study

Who is it for?
Ages 1 year and older, men only
Conditions the study is for
Trauma;Pelvis
What is being tested?
Urethroplasty
Type of treatment
Surgery or procedure
How many people
30 participants
Where
No sites listed yet
Study dates
1 Jun 2018to 1 May 2020
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 1 year and older
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Male patients underwent surgical repair of post traumatic urethral injury

The inclusion criteria are:

All patients with pelvic fracture and urethral distraction injury (PFUDDI) except patients with any of the exclusion criteria.

The exclusion criteria are:

  1. Bladder neck injury
  2. Rectal injury
  3. Urethrorectal injury
  4. Spinal cord injury
  5. Associated anterior urethral strictures

Trial locations and contacts

No sites are listed yet.

Abd El Rahman Abd El Kader, MD contact

01068336396

abdelrahmanmohamed.aa@gmail.com

About this study

Official title: Urological Outcome of Posterior Urethroplasty in Patients With Pelvic Fracture and Urethral Distraction Defect in Assuit University

The management of posterior urethral disruption secondary to blunt pelvic injury remains controversial. While many groups have recommended early realignment of urethral distraction injuries, Classic reports advocate a suprapubic cystostomy at the time of injury with delayed, perineal approach urethral re- construction 4 to 6 months after injury . Timing of the intervention typically is classified as :

  1. -Immediate treatment: when it takes place less than 48 hours after injury,
  2. -Delayed primary treatment : after 2 to 14 days, and
  3. -Deferred treatment : 3 months or more after injury.
Read the detailed description

It is important to make a distinction between posterior urethral stricture and a pelvic fracture urethral distraction defect. Urethral stricture indicate a narrowing of the urethral continuity due to either instrumentation or partial urethral tears. In urethral distraction defects there is a gap between the membranous urethra and the bulbar urethral end. A distraction injury also involve all or any portion of the membranous urethra.

The management of posterior urethral disruption secondary to blunt pelvic injury remains controversial. While many groups have recommended early realignment of urethral distraction injuries, Classic reports advocate a suprapubic cystostomy at the time of injury with delayed, perineal approach urethral re- construction 4 to 6 months after injury. Timing of the intervention typically is classified as :

  1. -Immediate treatment: when it takes place less than 48 hours after injury,
  2. -Delayed primary treatment : after 2 to 14 days, and
  3. -Deferred treatment : 3 months or more after injury.

Immediate open repair of posterior urethral injuries is usually associated with a higher incidence of strictures, re-stenosis, incontinence and impotence. Difficulty in identifying structures and planes as a result of hematoma formation and edema also hamper adequate mobilization and subsequent surgical apposition.

Contemporary urethral realignment employs actual realignment by fluoroscopic and endoscopic guidance of flexible cystoscopes that keep the urethral ends in the same cephalocaudad axis, followed by Seldinger technique catheter placement. The urethral catheter, which is usually maintained for 4 to 6 weeks, acts as a guide that allows the distracted urethral ends to come together as the pelvic hematoma slowly resorbs.

In the unstable or multisystem trauma patient, realignment often is delayed a few days to weeks (typically 2 to 14 days). the patient is managed by damage control and resuscitated in the intensive care unit while the urine is diverted by suprapubic tube placement first. Once the patient is stable, delayed urethral realignment is performed. Endourologic and radiologic techniques for realignment, theoretically, should not affect potency or urinary continence because no manipulation occurs of the periprostatic tissues or neurovascular bundles.

Types of surgical repair employed in posterior urethral distraction defect are 1) anastomotic urethroplasty, 2) Buccal mucosal urethroplasty, 3)Scrotal or penile island and 4) Johansen's urethroplasty. We aim to compare the outcomes of different management approachs for patients with posterior urethral distraction injuries after pelvic fractures in Assiut University Hospitals.

Aim of the work To evaluate outcomes of posterior urethroplasty in patients with pelvic fractures and posterior urethral distraction defect according to different patient characteristics (Age, prior manipulation), type of injury (type of fracture, gap length) and time of intervention.

Conditions
Trauma;Pelvis
Being tested
Urethroplasty

What participants receive

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

  • UrethroplastyProcedure or surgery

    Surgical repair of Urethral injury

Study groups in NCT03533270
Study groupRoleWhat they receive
UrethroplastyPatients with traumatic urethral injury associated with pelvic fractures who underwent urethroplasty
Receives: Procedure: Urethroplasty

What is being measured

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

  1. Presence of lower urinary tract symptoms

    eg, hesitancy, frequency, obstruction

    Measured: 1 year

Timeline

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

  1. First posted23 May 2018
  2. Study start1 Jun 2018 (estimated)
  3. Primary completion1 Oct 2019 (estimated)
  4. Study completion1 May 2020 (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
Case only
Time perspective
Retrospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03533270
Sponsor's protocol ID
uretheroplasty
Status last verified
May 2018
First submitted
10 May 2018
Last updated
23 May 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Trauma;Pelvis, 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?

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 23 May 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 Abd El Rahman Abd El Kader, MD (01068336396, abdelrahmanmohamed.aa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of lower urinary tract symptoms (time frame: 1 year). 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 23 May 2018.

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