Antibiotic Use Following Distal and Mid-shaft Hypospadias Repair

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Prophylactic Antibiotics Following Distal/Mid-shaft Hypospadias Repair: Are They Necessary?

Conditions
-----------------
Hypospadias

Intervention / Treatment
-----------------
* Drug: Septra


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 2 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antibiotics Group<br>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. | Drug: Septra<br> <br> * Other names: Sulfamethoxazole/trimethoprim;|
| No Intervention: No Antibiotics Group<br>Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Urinary Tract Infection | Urinary tract infection (UTI) will be diagnosed based on urine culture positive at 50,000CFUs per mL with one or both of the following: fever >38 Celsius, or significant fussiness and irritability with voiding per parent report. Asymptomatic bacteriuria is known and expected in this population; therefore culture positive results alone will not be sufficient to meet the definition of UTI. | 4-8 days post-operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibiotic Prophylaxis