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Multi-stage Urethroplasty with Augmentation Using a Dorsal Graft Inlay Technique Comparing Graft Use in First or Second Stage
Sponsor: University Hospital, Ghent
Summary
The principal aim of this pilot study is to directly compare both approaches and analyze the failure rate after one year of follow-up. These data will serve as the basis to design a larger phase II or III trial in the future with failure rate as the primary end-point. Other study objectives are thoroughly described underneath.
Official title: MAGIC I TRIAL - Multi-stage Urethroplasty with Augmentation Using a Dorsal Graft Inlay Technique Comparing Graft Use in First or Second Stage: a Randomized Controlled Pilot Study
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2020-11-11
Completion Date
2025-03-01
Last Updated
2024-09-19
Healthy Volunteers
No
Conditions
Interventions
Multi-stage urethroplasty with graft inlay in first stage
Herein, the graft will be used in the first stage and the second stage will solely consist of retubularizing the urethra.
Multi-stage urethroplasty with graft inlay in second stage
Herein, the graft will be used in the second stage and the first stage will solely consist of opening the urethra longitudinally.
Locations (1)
Ghent University Hospital
Ghent, Belgium