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

Not Applicable

Terminated

Conditions: Hypospadias

Interventions: Drug: placebo-controlled
Drug: Prednisolone

Registration Number: NCT02162810

Lead Sponsor: Francis Schneck

Brief 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).

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Male

Target Recruitment: 28

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
placebo-controlled	placebo-controlled	Simple Syrup will be used as the placebo
oral steroids	Prednisolone	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.

Primary Outcome Measures

Name	Time	Method
Meatus Location After Hypospadias Repair	after stent removal at 4-12 weeks	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).
Improvement of Chordee After Hypospadias Repair	postoperative follow up 7-12 days after the surgery following completion of the 5-day course of prednisolone vs. placebo.	Improvement of Chordee post-operatively after Hypospadias repair.
Complication Rate After Hypospadias Repair	after stent removal at 4-12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Complications After Hypospadias Repair	6 months after surgery	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.
Meatus Location After Hypospadias Repair	6-months after surgery	The overall cosmetic appearance of the phallus (i.e. location of the urethral meatus) 6 months post-operatively.
Healing Outcomes After Hypospadias Repair, Follow up After Toilet Training	Approximately at 4 years of age	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.