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).
Hypospadias repair is a surgery that is, unfortunately, fraught with a high complication rate with problems that include urethrocutaneous fistula formation, complete wound breakdown, glans dehiscence, urethral diverticulum formation, retraction of the urethral meatus, urethral stricture, and meatal stenosis . Failure of a proximal hypospadias repair (i.e. the development of a post-operative complication) is unpredictable, and few modifiable risk factors having been identified. Complications necessitate subsequent surgical intervention for pediatric patients, which must be carried out under general anesthesia. Evidence regarding the harms of multiple general anesthetics for children is increasing. Additionally, with each surgical revision comes the morbidity associated with another post-surgical convalescence. Thus, any measure that can be gained as a way to increase the rate of success of proximal hypospadias repair would be of help to all pediatric urologists and patients with hypospadias. The proposed intervention of administering a 5 day course of placebo versus oral steroids at a dose equivalent to what is given for outpatient treatment of asthma exacerbations, is expected to have very low risk. This would be the only variation from the current practice and one that has never been studied in the past. Thus, it would be worthwhile to perform use scientific methods to determine if the administration of a short course of oral steroids is of benefit to healing and minimization of post-operative complications for hypospadias patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
In order to analyze the data, we will establish a chart which will show the degree of cosmetic appearance, incidences and degree of complications. This we be assessed on a mild to severe scale.
In order to analyze the data, we will establish a chart which will show the degree of cosmetic appearance, incidences and degree of complications. This we be assessed on a mild to severe scale.
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Complication Rate After Hypospadias Repair
Post-operative incidence of wound breakdown, fistula formation, stenosis or stricture formation, and the need for subsequent redo-hypospadias surgeries and/or fistula repairs, after Hypospadias repair.
Time frame: postoperative follow up 7-12 days after the surgery following completion of the 5-day course of prednisolone vs. placebo.
Meatus Location After Hypospadias Repair
The overall cosmetic appearance of the phallus (i.e. location of the urethral meatus) post-operatively.
Time frame: postoperative follow up 7-12 days after the surgery following completion of the 5-day course of prednisolone vs. placebo.
Improvement of Chordee After Hypospadias Repair
Improvement of Chordee post-operatively after Hypospadias repair.
Time frame: postoperative follow up 7-12 days after the surgery following completion of the 5-day course of prednisolone vs. placebo.
Complication Rate After Hypospadias Repair
Post-operative incidence of wound breakdown, fistula formation, stenosis or stricture formation, and the need for subsequent redo-hypospadias surgeries and/or fistula repairs, after Hypospadias repair.
Time frame: after stent removal at 4-12 weeks
Meatus Location After Hypospadias Repair
Post operative follow-up after stent removal at 4-12 weeks of the overall cosmetic appearance of the phallus (i.e. location of the urethral meatus).
Time frame: after stent removal at 4-12 weeks
Complications After Hypospadias Repair
6-month follow-up incidence of wound breakdown, fistula formation, stenosis or stricture formation, and the need for subsequent redo-hypospadias surgeries and/or fistula repairs, after Hypospadias repair.
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Masking
DOUBLE
Enrollment
28
Time frame: 6 months after surgery
Meatus Location After Hypospadias Repair
The overall cosmetic appearance of the phallus (i.e. location of the urethral meatus) 6 months post-operatively.
Time frame: 6-months after surgery
Healing Outcomes After Hypospadias Repair, Follow up After Toilet Training
i) 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) the quality of wound healing including improvement of Chordee, and the overall cosmetic appearance of the phallus (i.e. location of the urethral meatus). Late complications can occur. Therefore, this needs to be evaluated at the specified interval. This is the standard of care at Children's Hospital of Pittsburgh of UPMC Pediatric Urology department.
Time frame: Approximately at 4 years of age