Trials / Completed
CompletedNCT03572348
VeSpAR: Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Strictures.
VeSpAR: A Randomized Controlled Trial Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Urethral Strictures
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- University Hospital, Ghent · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The investigators want to verify whether the surgical outcome of vessel-sparing anastomotic repair in isolated short bulbar urethral strictures is not inferior to the surgical outcome of transecting anastomotic repair. Furthermore, the investigators compare the functional outcome of both techniques verifying if there is less erectile dysfunction after vessel-sparing anastomotic repair than after transecting anastomotic repair.
Detailed description
A randomized controlled trial comparing vessel-sparing anastomotic repair (vsAR) and transecting anastomotic repair (tAR) in isolated short bulbar urethral strictures (maximum 3 centimeter) for both surgical and functional outcome, to demonstrate that vsAR is not inferior to tAR regarding the surgical outcome, and to demonstrate a benefit for vsAR over tAR regarding postoperative erectile function.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Transecting anastomotic repair (tAR) | Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply. |
| PROCEDURE | Vessel-sparing anastomotic repair (vsAR) | Alternative technique, leaving the bulbar arteries intact, only transecting and excising the narrow segment of the urethra and the surrounding spongiofibrosis. |
Timeline
- Start date
- 2018-09-26
- Primary completion
- 2023-12-14
- Completion
- 2023-12-14
- First posted
- 2018-06-28
- Last updated
- 2024-01-08
Locations
13 sites across 8 countries: United States, Argentina, Belgium, China, Mexico, Portugal, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT03572348. Inclusion in this directory is not an endorsement.