Antibiotic Use Following Distal and Mid-shaft Hypospadias Repair

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-04

Study Completion Date

2018-04-30

Brief Summary

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The purpose of this study is to evaluate the efficacy of prophylactic antibiotics following distal or mid-shaft hypospadias repair in influencing the rate of postoperative urinary tract infection and complications.

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Detailed Description

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The rationale for using prophylactic antibiotics after hypospadias surgery is to decrease the occurrence of urinary tract infections (UTIs) and complications. However, even though prophylactic antibiotics are used by some pediatric urologists, to date there has been no evidence supporting the role of prophylactic antibiotics in decreasing UTIs or complications. This is a prospective, randomized trial involving children undergoing distal or mid-shaft hypospadias repair. Subjects randomized into a group taking prophylactic dosages of antibiotics and a group not receiving post-operative antibiotics.

Conditions

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Hypospadias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Antibiotics Group

Patients randomized to this arm will receive prophylactic oral antibiotics following the surgery and catheter placement (Septra, 3 mg/kg/dose once daily), and will continue the medication for until the day before catheter removal 4-8 days post-operation.

Group Type EXPERIMENTAL

Septra

Intervention Type DRUG

No Antibiotics Group

Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Septra

Intervention Type DRUG

Other Intervention Names

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Bactrim Sulfamethoxazole/trimethoprim

Eligibility Criteria

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Inclusion Criteria

* all children between ages 6 months to 2 years under going distal or mid shaft hypospadias repair
* children of parents who give informed consent
* English speaking
* participant must be available for follow-up 3 and 12 months post-surgery

Exclusion Criteria

* all proximal hypospadias and redo hypospadias repairs
* children who are allergic to sulfa medications
* patients who have UTI at time of surgery (proven by culture)

Minimum Eligible Age

6 Months

Maximum Eligible Age

2 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No