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We were unable to meet our enrollment goal necessary to analyze the outcome measures.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral steroids | Active Comparator | 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. |
|
| placebo-controlled | Placebo Comparator | Simple Syrup will be used as the placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Rate After Hypospadias Repair | 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. | 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 | The overall cosmetic appearance of the phallus (i.e. location of the urethral meatus) post-operatively. | 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 | Improvement of Chordee post-operatively after Hypospadias repair. | 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 | 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. | after stent removal at 4-12 weeks |
| Meatus Location After Hypospadias Repair | 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). | after stent removal at 4-12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Complications After Hypospadias Repair | 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. | 6 months after surgery |
| Meatus Location After Hypospadias Repair |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis Schneck, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complication Rate After Hypospadias Repair | 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. | Posted | Count of Participants | Participants | postoperative follow up 7-12 days after the surgery following completion of the 5-day course of prednisolone vs. placebo. |
|
6 months post-op.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Kenyon, research coordinator | UPMC Children's Hospital of Pittsburgh | 4126923058 | kenyonkl@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 6, 2019 | Oct 23, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007021 | Hypospadias |
| ID | Term |
|---|---|
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D000072473 | Fused-Ring Compounds |
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|
| placebo-controlled | Drug | 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. |
|
|
The overall cosmetic appearance of the phallus (i.e. location of the urethral meatus) 6 months post-operatively. |
| 6-months after surgery |
| Healing Outcomes After Hypospadias Repair, Follow up After Toilet Training | 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. | Approximately at 4 years of age |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| NICU Stay | Count of Participants | Participants |
|
| Incidence of Comorbidities | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| Primary | Meatus Location After Hypospadias Repair | The overall cosmetic appearance of the phallus (i.e. location of the urethral meatus) post-operatively. | Posted | Count of Participants | Participants | postoperative follow up 7-12 days after the surgery following completion of the 5-day course of prednisolone vs. placebo. |
|
|
|
|
| Primary | Improvement of Chordee After Hypospadias Repair | Improvement of Chordee post-operatively after Hypospadias repair. | Posted | Count of Participants | Participants | postoperative follow up 7-12 days after the surgery following completion of the 5-day course of prednisolone vs. placebo. |
|
|
|
|
| Primary | Complication Rate After Hypospadias Repair | 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. | Further statistical analyses were not conducted on the data due to insufficient enrollment and follow-up participation, resulting in study termination. | Posted | Count of Participants | Participants | after stent removal at 4-12 weeks |
|
|
|
| Primary | Meatus Location After Hypospadias Repair | 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). | Further statistical analyses were not conducted on the data due to insufficient enrollment and follow-up participation, resulting in study termination. | Posted | Count of Participants | Participants | after stent removal at 4-12 weeks |
|
|
|
| Secondary | Complications After Hypospadias Repair | 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. | Further statistical analyses were not conducted on the data due to insufficient enrollment and follow-up participation, resulting in study termination. | Posted | Count of Participants | Participants | 6 months after surgery |
|
|
|
| Secondary | Meatus Location After Hypospadias Repair | The overall cosmetic appearance of the phallus (i.e. location of the urethral meatus) 6 months post-operatively. | Further statistical analyses were not conducted on the data due to insufficient enrollment and follow-up participation, resulting in study termination. | Posted | Count of Participants | Participants | 6-months after surgery |
|
|
|
| Secondary | Healing Outcomes After Hypospadias Repair, Follow up After Toilet Training | 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. | 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. | Posted | Approximately at 4 years of age |
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | 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. | 0 | 11 | 0 | 11 | 0 | 11 |
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| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011083 |
| Polycyclic Compounds |
| subcoronal |
|
| distal shaft |
|
| proximal shaft |
|
| penoscrotal |
|
| other |
|
| improvement described but not documented |
|
| no improvement |
|
| not described |
|
| improvement in ventral chordee |
|
| improvement of chordee with plication |
|
| <.64 |
| Other |
| Improvement category: Chordee with Plication | Fisher Exact | <.85 | Other |
| glans dehiscence |
|
| skin breakdown along suture lines, urethra intact |
|
| urethra breakdown proximal to glans |
|
| urethrocutaneous fistula |
|
| suspected stricture |
|
| suspected urethral diverticulum |
|
| subcoronal |
|
| distal shaft |
|
| proximal shaft |
|
| penoscrotal |
|
| other |
|
| glans dehiscence |
|
| skin breakdown along suture lines, urethra intact |
|
| urethra breakdown proximal to glans |
|
| urethrocutaneous fistula |
|
| suspected stricture |
|
| suspected urethral diverticulum |
|
| subcoronal |
|
| distal shaft |
|
| proximal shaft |
|
| penoscrotal |
|
| other |
|