Clinical trial NCT02162810: Effect of Steroids on Post-Operative Complications Following Proximal Hypospadias Repair
Official title: Effect of Steroids on Post-Operative Complications Following Proximal Hypospadias Repair
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypospadias
Keywords: hypospadias
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2014-06-13
Enrollment: 28
Sex: MALE
Minimum age (years): 3
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complication Rate After Hypospadias Repair
timeFrame: postoperative follow up 7-12 days after the surgery following completion of the 5-day course of prednisolone vs. placebo.
measure: Meatus Location After Hypospadias Repair
timeFrame: postoperative follow up 7-12 days after the surgery following completion of the 5-day course of prednisolone vs. placebo.
measure: Improvement of Chordee After Hypospadias Repair
timeFrame: postoperative follow up 7-12 days after the surgery following completion of the 5-day course of prednisolone vs. placebo.
measure: Complication Rate After Hypospadias Repair
timeFrame: after stent removal at 4-12 weeks
measure: Meatus Location After Hypospadias Repair
timeFrame: after stent removal at 4-12 weeks
Secondary outcomes:
measure: Complications After Hypospadias Repair
timeFrame: 6 months after surgery
measure: Meatus Location After Hypospadias Repair
timeFrame: 6-months after surgery
measure: Healing Outcomes After Hypospadias Repair, Follow up After Toilet Training
timeFrame: Approximately at 4 years of age
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Francis Schneck, MD
role: PRINCIPAL_INVESTIGATOR
References: