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

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ClinicalTrials.gov Identifier: NCT02162810
Recruitment Status : Recruiting
First Posted : June 13, 2014
Last Update Posted : November 11, 2019
Sponsor:
Information provided by (Responsible Party):
Francis Schneck, University of Pittsburgh

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).

Condition or disease Intervention/treatment Phase
Hypospadias Drug: Prednisolone Drug: placebo-controlled Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Effect of Steroids on Post-Operative Complications Following Proximal Hypospadias Repair
Study Start Date : May 2014
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Drug: 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.
Other Name: Steroid

Placebo Comparator: placebo-controlled
Simple Syrup will be used as the placebo
Drug: 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.
Other Name: Unknowen




Primary Outcome Measures :
  1. Healing Outcomes after Hypospadias Repair [ Time Frame: postoperative follow up 7-12 days after the surgery following completion of the 5-day course of prednisolone vs. placebo. ]
    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 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.

  2. Healing Outcomes after Hypospadias Repair postoperatively after stent removal [ Time Frame: 4 to 12 weeks ]
    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 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.


Secondary Outcome Measures :
  1. Healing Outcomes after Hypospadias Repair 6 months after surgery [ Time Frame: 6-months ]
    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 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.

  2. Healing Outcomes after Hypospadias Repair Follow up after toilet training [ Time Frame: Approximately at 4 years of age ]
    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 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.



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Ages Eligible for Study:   3 Months to 22 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162810


Contacts
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Contact: Jennifer Szczepaniak, BS 412-692-6203 jennifer.szczepaniak@chp.edu
Contact: Dawn McBride, RN,BSN 412-623-2764 mcbridedl@upmc.edu

Locations
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United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Francis Schneck, MD    412-692-3042    francis.schneck@chp.edu   
Contact: Jennifer Szczepaniak, BS    412-692-6203    jennifer.szczepaniak@chp.edu   
Sponsors and Collaborators
Francis Schneck
Investigators
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Principal Investigator: Francis Schneck, MD University of Pittsburgh

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Responsible Party: Francis Schneck, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02162810     History of Changes
Other Study ID Numbers: PRO14010275
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: November 11, 2019
Last Verified: November 2019
Keywords provided by Francis Schneck, University of Pittsburgh:
hypospadias
Additional relevant MeSH terms:
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Hypospadias
Autonomic Agents
Postoperative Complications
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Pathologic Processes
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents