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

NCT02162810 | Terminated Results

• 1 other identifier: PRO14010275
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypospadias

Keywords

hypospadias

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (3)

• Complications After Hypospadias Repair

  6 months after surgery

• Meatus Location After Hypospadias Repair

  6-months after surgery

• Healing Outcomes After Hypospadias Repair, Follow up After Toilet Training

  Approximately at 4 years of age

Study Arms (2)

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.

Drug: Prednisolone

placebo-controlled

PLACEBO COMPARATOR

Simple Syrup will be used as the placebo

Drug: placebo-controlled

Interventions

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.

Also known as: Steroid

oral steroids

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.

Also known as: Unknowen

placebo-controlled

Eligibility Criteria

• Age: 3 Months - 22 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients undergoing proximal hypospadias repair

You may not qualify if:

• 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.

Sponsors & Collaborators

• Francis Schneck: lead

Study Sites (1)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Hypospadias

Interventions

Prednisolone; Steroids

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Karen Kenyon, research coordinator
• Organization: UPMC Children's Hospital of Pittsburgh

kenyonkl@upmc.edu

4126923058

Study Officials

• Francis Schneck, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 11, 2014
• First Posted: June 13, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: December 22, 2023
• Results First Posted: December 22, 2023

Record last verified: 2023-12

Locations

US (1)