Clinical trial

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

Name

PRO14010275

Description

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).

Trial arms

Trial start

2014-05-01

Estimated PCD

2022-05-01

Trial end

2022-05-01

Status

Terminated

Treatment

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.

Arms:

oral steroids

Other names:

Steroid

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.

Arms:

placebo-controlled

Other names:

Unknowen

Size

Primary endpoint

Complication Rate 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

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

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

after stent removal at 4-12 weeks

Meatus Location After Hypospadias Repair

after stent removal at 4-12 weeks

Eligibility 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 28, 'type': 'ACTUAL'}}

Updated at

2023-12-22

1 organization

2 products

1 indication

Organization

Product

Indication

Product