drugset / Trial / NCT02162810

Effect of Steroids on Post-Operative Complications Following Proximal Hypospadias Repair

NCT02162810

Terminated 28 enrolled Francis Schneck
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

EvaluationDrugModalityDoseRoute
Comparator Prednisolone Other / unclassified 1 mg/kg Oral
Comparator Prednisolone Other / unclassified 2 mg/kg Oral

Indications