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

December 21, 2023 updated by: Francis Schneck
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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Children's Hospital of Pittsburgh of UPMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Unknowen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication Rate 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: after stent removal at 4-12 weeks
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
Time Frame: after stent removal at 4-12 weeks
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications After Hypospadias Repair
Time Frame: 6 months after surgery
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
Time Frame: 6-months after surgery
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
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 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Francis Schneck

Investigators

  • Principal Investigator: Francis Schneck, MD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

March 11, 2014

First Submitted That Met QC Criteria

June 10, 2014

First Posted (Estimated)

June 13, 2014

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO14010275

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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