Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248047
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-31
Brief Title:
Vessel-sparing Technique Versus Conventional Repair of PFUI A Prospective Comparative Study
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Vessel-sparing Technique Versus Conventional Repair of Pelvic Fracture Urethral Injury A Prospective Comparative Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pelvic fracture is associated with urethral injury in about 10 of patients The common site of injury is at the bulbomembranous Junction and anastomotic urethroplasty with a tension free anastomosis remains the gold standard management for pelvic fracture urethral injury PFUI
Traditional reconstruction of PFUI requires mobilization of the bulbar urethra to reach the prostatic apex with deep dissection of the spongiosum and detachment of the bulb from the perineal membrane at the site of the bulbomembranous urethral injury a maneuver that requires division of the bulbar arteries Then the distal bulb and bulbar urethra will depend on retrograde blood flow through the glans and some perforating branches of the dorsal penile artery and this is usually sufficient to maintain good vitality of the spongiosum and urethra under normal circumstances
When the distal blood supply to the urethra is compromised either by congenital anomalies such a hypospadias by previous surgery or by the pre-existing pelvic fracture the retrograde flow to the spongiosum is insufficient In such cases traditional anastomotic urethroplasty may result in ischemic bulbar necrosis leading to a reconstructive failure and these patients usually fail to void soon after removal of the catheter with subsequent retrograde urethrogram RUG showing a long bulbar urethral defect
In 2007 Jordan et al described a modification to excision and primary anastomosis EPA in the proximal bulbar urethral strictures particularly post radical prostatectomy which includes mobilizing and preserving the bulbar arteries with the continuity of the corpus spongiosum is maintained
Gomez et al believed that vessel-sparing anastomotic urethroplasty is highly relevant in the PFUI scenario as it can theoretically help to avoid ischemic failure and cold glans syndrome improving sexual arousal Consequently they modified the standard reconstructive technique for PFUI by preserving bulbar arterial inflow
So that we decide to compare between vessel-sparing technique and conventional repair in management of PFUI through a prospective study
Traditional reconstruction of PFUI requires mobilization of the bulbar urethra to reach the prostatic apex with deep dissection of the spongiosum and detachment of the bulb from the perineal membrane at the site of the bulbomembranous urethral injury a maneuver that requires division of the bulbar arteries Then the distal bulb and bulbar urethra will depend on retrograde blood flow through the glans and some perforating branches of the dorsal penile artery and this is usually sufficient to maintain good vitality of the spongiosum and urethra under normal circumstances
When the distal blood supply to the urethra is compromised either by congenital anomalies such a hypospadias by previous surgery or by the pre-existing pelvic fracture the retrograde flow to the spongiosum is insufficient In such cases traditional anastomotic urethroplasty may result in ischemic bulbar necrosis leading to a reconstructive failure and these patients usually fail to void soon after removal of the catheter with subsequent retrograde urethrogram RUG showing a long bulbar urethral defect
In 2007 Jordan et al described a modification to excision and primary anastomosis EPA in the proximal bulbar urethral strictures particularly post radical prostatectomy which includes mobilizing and preserving the bulbar arteries with the continuity of the corpus spongiosum is maintained
Gomez et al believed that vessel-sparing anastomotic urethroplasty is highly relevant in the PFUI scenario as it can theoretically help to avoid ischemic failure and cold glans syndrome improving sexual arousal Consequently they modified the standard reconstructive technique for PFUI by preserving bulbar arterial inflow
So that we decide to compare between vessel-sparing technique and conventional repair in management of PFUI through a prospective study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None