drugset / Trial / NCT02162810
Effect of Steroids on Post-Operative Complications Following Proximal Hypospadias Repair
RandomizedFactorialDouble-blindHealth-services research
Summary
The primary objective of this study is to determine the efficacy of administering a course of postoperative oral steroids in pediatric patients undergoing proximal hypospadias repair as prevention against complications. Specifically, the study aims to assess if the steroids i) decrease the incidence of wound breakdown, fistula formation, stenosis or stricture formation, and the need for subsequent redo-hypospadias surgeries and/or fistula repairs and ii) improve the quality of wound healing including the overall cosmetic appearance of the phallus (i.e. location of the urethral meatus).
Timeline
- Start
- 2014-05
- Primary completion
- 2022-05
- Completion
- 2022-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Prednisolone | Other / unclassified | 1 mg/kg | Oral |
| Comparator | Prednisolone | Other / unclassified | 2 mg/kg | Oral |