Urological Outcome of Posterior Urethroplasty in Patients in Assuit University

May 10, 2018 updated by: Abdelrahman Mohamed Abdelkader, Assiut University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

30

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

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Male patients underwent surgical repair of post traumatic urethral injury

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Urethroplasty
Patients with traumatic urethral injury associated with pelvic fractures who underwent urethroplasty
Surgical repair of Urethral injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of lower urinary tract symptoms
Time Frame: 1 year
eg, hesitancy, frequency, obstruction
1 year

Collaborators and Investigators

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

Investigators

  • Study Director: Medhat El Hawary, MD, PhD, Assiut University

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)

June 1, 2018

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

May 10, 2018

First Submitted That Met QC Criteria

May 10, 2018

First Posted (Actual)

May 23, 2018

Study Record Updates

Last Update Posted (Actual)

May 23, 2018

Last Update Submitted That Met QC Criteria

May 10, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • uretheroplasty

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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