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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Hypospadias

Intervention / Treatment
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* Drug: Prednisolone
* Drug: placebo-controlled


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing proximal hypospadias repair Exclusion Criteria: All patients currently taking steroids at the time of surgery or during the six-week recovery period as well as patients with betamethasone hypersensitivity will be excluded from the study. Selection will be based on parent willingness to allow the child to participate in the study.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 22 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oral steroids<br>Systemic high-dose steroids (30 mg/kg methylprednisolone) have been shown in a randomized, double-blind, placebo-controlled trial in humans not to negatively impact wound infection or dehiscence rates, instead benefitting patients in the postoperative period in ways such as decreasing pain. An acute course of oral systemic steroids has been routinely used in patients under the age of 12 with asthma exacerbations (liquid prednisolone at 1-2 mg/kg/day in 1-2 divided doses for up to 10 days, although usually given for 5 days, which is at least 19 times less than the dose proven to be safe in the randomized controlled trial mentioned above) and proven to be safe without adverse effects. Effect of prednisolone on the systemic response and wound healing after colonic surgery. | Drug: Prednisolone<br>* 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.<br>* Other names: Steroid;|
| Placebo Comparator: placebo-controlled<br>Simple Syrup will be used as the placebo | Drug: placebo-controlled<br>* 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.<br>* Other names: Unknowen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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). | after stent removal at 4-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Approximately at 4 years of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypospadias