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

Hypospadias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02162810
• Other study ID #: PRO14010275
• Status: Terminated
• Phase: N/A
• Start date: May 2014
• Est. completion date: May 2022

Study information

• Verified date: December 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 3 Months to 22 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypospadias
• Postoperative Complications

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Francis Schneck

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	postoperative follow up 7-12 days after the surgery following completion of the 5-day course of prednisolone vs. placebo.
Primary	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.
Primary	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.
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.	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).	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.	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.	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.	Approximately at 4 years of age