Vessel-sparing Technique Versus Conventional Repair of PF... | NCT06248047

NCT06248047

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

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Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
conventional repair		the patients will undergo repair with no regard to the vessels .then follow up by uroflow ,ascending urethrogram and penile doppler .	Procedure: uretheroplasty
the new technique		the patients will undergo repair with sparing of the vessels .then follow up by uroflow ,ascending urethrogram and penile doppler .	Procedure: uretheroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
uretheroplasty	Procedure	4. When the bulb and bulbar urethra are exposed and before further dissection, the bulbar arteries are located using a directional doppler ultrasound stethoscope and a decision is made to sacrifice the artery with the lowest doppler signal to preserve the contralateral best artery. The bulbar urethra is then mobilized, circumferentially dissected and separated distally from the corpus cavernosum up to the penoscrotal angle to gain sufficient length for a tension-free end-to-end anastomosis without detachment of the bulb from the perineal body. If the dissection is not sufficient to bridge the gap,inter-corporal septal separation or even an inferior pubectomy are performed. The scarred tissue is removed completely, the proximal urethral segment is exposed as usual with spatulation of the healthy urethral ends and end-to-end anastomosis of the urethra over a silicon catheter is performed. No dissection is performed contralaterally at the bulb to preserve the artery of that side.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
UROFLOWMETERY	the speed and feasibility of micturition measured by non invasive pressure flow study Q max more than 10ml/sec	three months after the operation
postmicturition residue	abdominal ultrasound done to evaluate PMR	three months after the operation
Retrograde Urethrogram RUG	contrast study to evaluate and delineate the urethera	three months after the operation

Eligibility Module

Name	Role	Phone	Extension	Email
Mena H Mahdy	Contact	01008413768		menaahosam1995@gmail.com

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University		Asyut			Egypt	Mohamed O Ali, MD

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23631324	Background	Durrant JJ, Ramasamy A, Salmon MS, Watkin N, Sargeant I. Pelvic fracture-related urethral and bladder injury. J R Army Med Corps. 2013 Mar;159 Suppl 1:i32-9. doi: 10.1136/jramc-2013-000025.
2005693	Background	Webster GD, Ramon J. Repair of pelvic fracture posterior urethral defects using an elaborated perineal approach: experience with 74 cases. J Urol. 1991 Apr;145(4):744-8. doi: 10.1016/s0022-5347(17)38442-2.

IPD Sharing Statement Module