Antibiotic Use in Distal Hypospadias Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-19

Study Completion Date

2017-04-19

Brief Summary

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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.

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Detailed Description

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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

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Hypospadias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Using the block randomization procedures, a subject was assigned to a study group by computer using the REDCap randomization module. Subjects were randomized to receive post operative antibiotics or to not receive any antibiotics postoperative.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antibiotics prophylaxis cohort

Subjects were prescribed prophylactic antibiotics after the hypospadias surgery.

Group Type ACTIVE_COMPARATOR

Randomization to receive prophylactic antibiotics after surgery

Intervention Type OTHER

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.

Antibiotic-sparing cohort

Subjects were not prescribed prophylactic antibiotics after the hypospadias surgery.

Group Type ACTIVE_COMPARATOR

Randomization to not receive prophylactic antibiotics after surgery.

Intervention Type OTHER

No antibiotics were ordered after surgery.

Interventions

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Randomization to not receive prophylactic antibiotics after surgery.

No antibiotics were ordered after surgery.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

3 Months

Maximum Eligible Age

6 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes