TerminatedNot Applicable

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

Stopped: We were unable to meet our enrollment goal necessary to analyze the outcome measures.

United States28 participantsStarted 2014-05

Plain-language 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).

Who can participate

Age range

3 Months – 22 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

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.

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.

Complication Rate After Hypospadias Repair

Timeframe: after stent removal at 4-12 weeks

Meatus Location After Hypospadias Repair

Timeframe: after stent removal at 4-12 weeks

Trial details

NCT IDNCT02162810

SponsorFrancis Schneck

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05

Results submitted2023-11-03

View on ClinicalTrials.gov More Hypospadias trials

Plain-language summary

Who can participate

Age range

3 Months – 22 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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.

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.

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.

Complication Rate After Hypospadias Repair

Timeframe: after stent removal at 4-12 weeks

Meatus Location After Hypospadias Repair

Timeframe: after stent removal at 4-12 weeks