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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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).

Detailed Summary: 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.
Sponsor: Children's Hospital of Pittsburgh

Current Primary Outcome:

• 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.
• 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.

Original Primary Outcome:

• 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.
• Healing Outcomes after Hypospadias Repair postoperatively after stent removel [ 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. Therfore, 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.

Current Secondary Outcome:

• 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.
• 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.

Original Secondary Outcome: Same as current

Information By: Children's Hospital of Pittsburgh

Dates:
Date Received: March 11, 2014
Date Started: May 2014
Date Completion: February 2020
Last Updated: August 30, 2016
Last Verified: August 2016