Trauma;PelvisNCT03533270
Urological Outcome of Posterior Urethroplasty in Patients in Assuit University
An observational study of Trauma;Pelvis, run by Assiut University.
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:
- Bladder neck injury
- Rectal injury
- Urethrorectal injury
- Spinal cord injury
- Associated anterior urethral strictures
Trial locations and contacts
No sites are listed yet.
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 :
- -Immediate treatment: when it takes place less than 48 hours after injury,
- -Delayed primary treatment : after 2 to 14 days, and
- -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 :
- -Immediate treatment: when it takes place less than 48 hours after injury,
- -Delayed primary treatment : after 2 to 14 days, and
- -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 group | Role | What they receive |
|---|---|---|
| Urethroplasty | Patients 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.
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.
- First posted23 May 2018
- Study start1 Jun 2018 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma;PelvisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Mohamed Abdelkader, Assiut University
- Investigators
- Medhat El Hawary, MD, PhD, Study director, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urological Outcome of Posterior Urethroplasty in Patients With Pelvic Fracture and Urethral Distraction Defect in Assuit University
- ClinicalTrials.gov ID
- NCT03533270
- Acronym / sponsor ID
- uretheroplasty
- Conditions
- Trauma;Pelvis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- -Immediate treatment: when it takes place less than 48 hours after injury,
- -Delayed primary treatment : after 2 to 14 days, and
- -Deferred treatment : 3 months or more after injury.
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 :
- -Immediate treatment: when it takes place less than 48 hours after injury,
- -Delayed primary treatment : after 2 to 14 days, and
- -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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urethroplasty | – | Procedure: UrethroplastyPatients with traumatic urethral injury associated with pelvic fractures who underwent urethroplasty |
Who may qualify
- Ages
- 1 year and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male patients underwent surgical repair of post traumatic urethral injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UrethroplastySurgical repair of Urethral injury | Procedure or surgery | Urethroplasty |
Primary outcome
Presence of lower urinary tract symptoms
Time frame: 1 year
eg, hesitancy, frequency, obstruction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
- Individual participant dataSharing planned: No
Related trials for Trauma;Pelvis
Active, not recruiting
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Bladder Cancer, Prostate Cancer
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
RecruitingObservational study
Pelvic and Acetabular Fracture: A Prospective Observational Study
Pelvic Fracture, Acetabular Fracture
Enrolling by invitationObservational study
Long-term Pelvic Floor and Sexual Health After Obstetric Anal Sphincter Injury in Finland
Obstetric Anal Sphincter Injury, Sexual Dysfunction and the Mode of Deliveries
RecruitingObservational study
Health Oriented Protocol for Epidermal Radiodermatitis
Head and Neck Cancer, Pelvic Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medhat El Hawary, MD, PhD study director
Assiut University
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.