NCT03275519

Antibiotic Use in Distal Hypospadias Repair

Randomized Trial of Antibiotic Prophylaxis for Prevention of Symptomatic UTI in Stented, Distal Hypospadias Repair

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Arkansas Children's Hospital Research Institute · Academic / Other
• Sex: Male
• Age: 3 Months – 6 Years
• Healthy volunteers: Accepted

Summary

Hypospadias is a common condition where the opening of the penis is not located at the tip, but along the underside of the penis. It is estimated to occur in 1/300 live male births, making it one of the most common birth defects. Degrees of hypospadias ranged from minor to severe depending on the location of the opening. Surgical repair is often required and involves placement of a catheter for the urine to drain with known urinary colonization found on prior retrospective studies. The current practice of using preventative antibiotics as long as the catheter is in place is conflicting with resent studies that show antibiotics may not be necessary to prevent urinary tract infections (UTIs). The purpose of this study was to see how common symptomatic UTIs were after hypospadias repair surgery; and to see whether routine antibiotic use after surgery affected the rate of UTIs. Subjects were randomized to either receive antibiotics or no antibiotics after distal hypospadias repair. The research coordinator made follow-up phone calls with the family and the primary care provider (PCP) after stent removal, 30 days post surgery and after the 3 month post surgical visit.

Detailed description

Males undergoing distal hypospadias repair involving stent placement were randomized to either receive or not to receive antibiotics post-operative. All subjects did not receive intra-operative antibiotics. Routine follow-up included having the stent removed one week post-op and a return visit at 3 months. The research nurse made follow-up phone calls to the family or the (PCP) one week after the stent was removed and at one month post-op to see how things were going with the child and again after teh 3 month post surgical visit, if the subject did not return after multiple rescheduling attempts.

Conditions

• Hypospadias

Interventions

Type	Name	Description
OTHER	Randomization to not receive prophylactic antibiotics after surgery.	No antibiotics were ordered after surgery.
OTHER	Randomization to receive prophylactic antibiotics after surgery	In general, the antibiotic given is a combination sulfamethoxazole/ trimethoprim oral suspension (2-3 mg trimethoprim/kg by mouth once a day); or if indicated, nitrofurantoin (1mg/kg by mouth once daily). All subjects did not receive intraoperative antibiotics.

Timeline

• Start date: 2015-01-19
• Primary completion: 2017-02-17
• Completion: 2017-04-19
• First posted: 2017-09-07
• Last updated: 2017-09-07

Locations

1 site across 1 country: United States