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



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:Any - 22
Updated:11/11/2018
Start Date:May 2014
End Date:February 2020
Contact:Jennifer Szczepaniak, BS
Email:jennifer.szczepaniak@chp.edu
Phone:412-692-6203

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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).

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.

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.
We found this trial at
1
site
4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Phone: 412-692-3042
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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