Trial Outcomes & Findings for Effect of Steroids on Post-Operative Complications Following Proximal Hypospadias Repair (NCT NCT02162810)

Last Updated: 2023-12-22

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

postoperative follow up 7-12 days after the surgery following completion of the 5-day course of prednisolone vs. placebo.

Results posted on

2023-12-22

Participant Flow

Participant milestones

Participant milestones
Measure	Oral Steroids 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. Prednisolone: 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.	Placebo-controlled Simple Syrup will be used as the placebo placebo-controlled: 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.
Overall Study STARTED	17	11
Overall Study COMPLETED	12	10
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Oral Steroids 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. Prednisolone: 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.	Placebo-controlled Simple Syrup will be used as the placebo placebo-controlled: 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.
Overall Study Protocol Violation	1	0
Overall Study patients did not report compliance	4	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Steroids n=17 Participants 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. Prednisolone: 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.	Placebo-controlled n=11 Participants Simple Syrup will be used as the placebo placebo-controlled: 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.	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	17 Participants n=17 Participants	11 Participants n=11 Participants	28 Participants n=28 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=17 Participants	0 Participants n=11 Participants	0 Participants n=28 Participants
Age, Categorical >=65 years	0 Participants n=17 Participants	0 Participants n=11 Participants	0 Participants n=28 Participants
Sex: Female, Male Female	0 Participants n=17 Participants	0 Participants n=11 Participants	0 Participants n=28 Participants
Sex: Female, Male Male	17 Participants n=17 Participants	11 Participants n=11 Participants	28 Participants n=28 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	17 participants n=17 Participants	11 participants n=11 Participants	28 participants n=28 Participants
NICU Stay	11 Participants n=17 Participants	5 Participants n=11 Participants	16 Participants n=28 Participants
Incidence of Comorbidities	6 Participants n=17 Participants	5 Participants n=11 Participants	11 Participants n=28 Participants

PRIMARY outcome

Timeframe: postoperative follow up 7-12 days after the surgery following completion of the 5-day course of prednisolone vs. placebo.

Outcome measures

Outcome measures
Measure	Oral Steroids n=17 Participants 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. Prednisolone: 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.	Placebo-controlled n=11 Participants Simple Syrup will be used as the placebo placebo-controlled: 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.
Complication Rate After Hypospadias Repair meatal retraction	1 Participants	0 Participants
Complication Rate After Hypospadias Repair meatal stenosis	0 Participants	0 Participants
Complication Rate After Hypospadias Repair glans dehiscence	0 Participants	1 Participants
Complication Rate After Hypospadias Repair skin breakdown along suture lines, urethra intact	0 Participants	0 Participants
Complication Rate After Hypospadias Repair urethra breakdown proximal to glans	0 Participants	0 Participants
Complication Rate After Hypospadias Repair urethrocutaneous fistula	2 Participants	0 Participants
Complication Rate After Hypospadias Repair suspected stricture	0 Participants	0 Participants
Complication Rate After Hypospadias Repair suspected urethral diverticulum	1 Participants	0 Participants

PRIMARY outcome

Timeframe: postoperative follow up 7-12 days after the surgery following completion of the 5-day course of prednisolone vs. placebo.

The overall cosmetic appearance of the phallus (i.e. location of the urethral meatus) post-operatively.

Outcome measures

Outcome measures
Measure	Oral Steroids n=17 Participants 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. Prednisolone: 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.	Placebo-controlled n=11 Participants Simple Syrup will be used as the placebo placebo-controlled: 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.
Meatus Location After Hypospadias Repair glanular	13 Participants	8 Participants
Meatus Location After Hypospadias Repair coronal	0 Participants	0 Participants
Meatus Location After Hypospadias Repair subcoronal	0 Participants	0 Participants
Meatus Location After Hypospadias Repair distal shaft	0 Participants	0 Participants
Meatus Location After Hypospadias Repair proximal shaft	0 Participants	0 Participants
Meatus Location After Hypospadias Repair penoscrotal	4 Participants	2 Participants
Meatus Location After Hypospadias Repair other	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Oral Steroids n=17 Participants 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. Prednisolone: 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.	Placebo-controlled n=11 Participants Simple Syrup will be used as the placebo placebo-controlled: 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.
Improvement of Chordee After Hypospadias Repair improvement of chordee with degloving · resolved	2 Participants	2 Participants
Improvement of Chordee After Hypospadias Repair improvement of chordee with degloving · improved	3 Participants	1 Participants
Improvement of Chordee After Hypospadias Repair improvement of chordee with degloving · improvement described but not documented	1 Participants	0 Participants
Improvement of Chordee After Hypospadias Repair improvement of chordee with degloving · no improvement	8 Participants	7 Participants
Improvement of Chordee After Hypospadias Repair improvement of chordee with degloving · not described	3 Participants	1 Participants
Improvement of Chordee After Hypospadias Repair improvement in ventral chordee · resolved	2 Participants	0 Participants
Improvement of Chordee After Hypospadias Repair improvement in ventral chordee · improved	2 Participants	2 Participants
Improvement of Chordee After Hypospadias Repair improvement in ventral chordee · improvement described but not documented	0 Participants	0 Participants
Improvement of Chordee After Hypospadias Repair improvement in ventral chordee · no improvement	5 Participants	2 Participants
Improvement of Chordee After Hypospadias Repair improvement in ventral chordee · not described	8 Participants	7 Participants
Improvement of Chordee After Hypospadias Repair improvement of chordee with plication · resolved	7 Participants	6 Participants
Improvement of Chordee After Hypospadias Repair improvement of chordee with plication · improved	1 Participants	1 Participants
Improvement of Chordee After Hypospadias Repair improvement of chordee with plication · improvement described but not documented	0 Participants	0 Participants
Improvement of Chordee After Hypospadias Repair improvement of chordee with plication · no improvement	0 Participants	0 Participants
Improvement of Chordee After Hypospadias Repair improvement of chordee with plication · not described	9 Participants	4 Participants

PRIMARY outcome

Timeframe: after stent removal at 4-12 weeks

Population: Further statistical analyses were not conducted on the data due to insufficient enrollment and follow-up participation, resulting in study termination.

Outcome measures

Outcome measures
Measure	Oral Steroids n=14 Participants 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. Prednisolone: 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.	Placebo-controlled n=10 Participants Simple Syrup will be used as the placebo placebo-controlled: 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.
Complication Rate After Hypospadias Repair meatal retraction	1 Participants	0 Participants
Complication Rate After Hypospadias Repair meatal stenosis	0 Participants	0 Participants
Complication Rate After Hypospadias Repair glans dehiscence	0 Participants	1 Participants
Complication Rate After Hypospadias Repair skin breakdown along suture lines, urethra intact	0 Participants	0 Participants
Complication Rate After Hypospadias Repair urethra breakdown proximal to glans	0 Participants	0 Participants
Complication Rate After Hypospadias Repair urethrocutaneous fistula	2 Participants	0 Participants
Complication Rate After Hypospadias Repair suspected stricture	0 Participants	0 Participants
Complication Rate After Hypospadias Repair suspected urethral diverticulum	0 Participants	0 Participants

PRIMARY outcome

Timeframe: after stent removal at 4-12 weeks

Population: Further statistical analyses were not conducted on the data due to insufficient enrollment and follow-up participation, resulting in study termination.

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).

Outcome measures

Outcome measures
Measure	Oral Steroids n=14 Participants 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. Prednisolone: 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.	Placebo-controlled n=10 Participants Simple Syrup will be used as the placebo placebo-controlled: 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.
Meatus Location After Hypospadias Repair glanular	9 Participants	8 Participants
Meatus Location After Hypospadias Repair coronal	1 Participants	1 Participants
Meatus Location After Hypospadias Repair subcoronal	0 Participants	0 Participants
Meatus Location After Hypospadias Repair distal shaft	0 Participants	0 Participants
Meatus Location After Hypospadias Repair proximal shaft	0 Participants	0 Participants
Meatus Location After Hypospadias Repair penoscrotal	3 Participants	2 Participants
Meatus Location After Hypospadias Repair other	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months after surgery

Population: Further statistical analyses were not conducted on the data due to insufficient enrollment and follow-up participation, resulting in study termination.

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.

Outcome measures

Outcome measures
Measure	Oral Steroids n=7 Participants 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. Prednisolone: 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.	Placebo-controlled n=3 Participants Simple Syrup will be used as the placebo placebo-controlled: 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.
Complications After Hypospadias Repair meatal retraction	0 Participants	0 Participants
Complications After Hypospadias Repair meatal stenosis	0 Participants	0 Participants
Complications After Hypospadias Repair glans dehiscence	0 Participants	0 Participants
Complications After Hypospadias Repair skin breakdown along suture lines, urethra intact	0 Participants	0 Participants
Complications After Hypospadias Repair urethra breakdown proximal to glans	0 Participants	0 Participants
Complications After Hypospadias Repair urethrocutaneous fistula	2 Participants	1 Participants
Complications After Hypospadias Repair suspected stricture	0 Participants	0 Participants
Complications After Hypospadias Repair suspected urethral diverticulum	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 6-months after surgery

Population: Further statistical analyses were not conducted on the data due to insufficient enrollment and follow-up participation, resulting in study termination.

The overall cosmetic appearance of the phallus (i.e. location of the urethral meatus) 6 months post-operatively.

Outcome measures

Outcome measures
Measure	Oral Steroids n=7 Participants 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. Prednisolone: 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.	Placebo-controlled n=3 Participants Simple Syrup will be used as the placebo placebo-controlled: 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.
Meatus Location After Hypospadias Repair glanular	4 Participants	1 Participants
Meatus Location After Hypospadias Repair coronal	0 Participants	1 Participants
Meatus Location After Hypospadias Repair subcoronal	0 Participants	0 Participants
Meatus Location After Hypospadias Repair distal shaft	0 Participants	0 Participants
Meatus Location After Hypospadias Repair proximal shaft	0 Participants	0 Participants
Meatus Location After Hypospadias Repair penoscrotal	3 Participants	1 Participants
Meatus Location After Hypospadias Repair other	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Approximately at 4 years of age

Population: The study was terminated prior to the 4 year follow up due to lack of sufficient patient data to analyze; therefore, there was no post-toilet training follow up data collected.

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.

Outcome measures

Outcome data not reported

Adverse Events

Oral Steroids

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo-controlled

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karen Kenyon, research coordinator

UPMC Children's Hospital of Pittsburgh

Phone: 4126923058

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place