Prophylactic Antibiotics Following Distal/Mid-shaft Hypospadias Repair: Are They Necessary?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Number of Participants With Urinary Tract Infection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 6 Months 至 2 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Septra (Drug)
结局指标
主要结局
Number of Participants With Urinary Tract Infection
时间窗: 4-8 days post-operation
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.
次要结局
未报告次要终点
研究者
Travis Groth
Assistant Professor, MD
Medical College of Wisconsin