Antibiotic Use in Distal Hypospadias Repair

Hypospadias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03275519
• Other study ID #: IRB# 203532
• Status: Completed
• Phase: N/A
• First received: August 11, 2017
• Last updated: September 6, 2017
• Start date: January 19, 2015
• Est. completion date: April 19, 2017

Study information

• Verified date: September 2017
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 19, 2017
• Est. primary completion date: February 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 3 Months to 6 Years

Eligibility

Inclusion Criteria:

• Males undergoing primary distal hypospadias repair with open urethral stent drainage.

Exclusion Criteria:

• Males undergoing fistula repair or glandular hypospadias repair without incontinent urethral stent drainage and hypospadias repair of mid or more proximal degrees of hypospadias were excluded from this study.

Related Conditions & MeSH terms

• Hypospadias

Intervention

Other:
• Randomization to not receive prophylactic antibiotics after surgery.
No antibiotics were ordered after surgery.
• 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.

Locations

Country	Name	City	State
United States	Arkansas Children's Hospital	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of symptomatic UTI within 30 days post-surgery	Assess the prevalence of symptomatic UTI in subjects receiving standard of care dispensation of prophylaxis versus subjects selected to an antibiotic-sparing cohort.	30 days post surgery
Secondary	Evaluation of surgical site infections (SSIs) and complications of hypospadias repair	Surgical site infections (SSIs) are measured using physical assessments at the stent removal visit. Complications of hypospadias repair (urethral fistula, meatal stenosis, dehiscence, and diverticulum) are measured using physical assessments at the stent removal visit and/or contact with the family or the PCP office 1 week after the stent removal; at the 30 day post operative time point; and at the 3 month follow-op visit.	Approximately post surgery: 2 weeks (stent is in approximately 1 week and then 1 week after the stent is removed); 30 days; and 3 months