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Antibiotic Use in Distal Hypospadias Repair

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ClinicalTrials.gov Identifier: NCT03275519
Recruitment Status : Completed
First Posted : September 7, 2017
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

Brief 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.


Condition or disease Intervention/treatment Phase
Hypospadias Other: Randomization to not receive prophylactic antibiotics after surgery. Other: Randomization to receive prophylactic antibiotics after surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Antibiotic Prophylaxis for Prevention of Symptomatic UTI in Stented, Distal Hypospadias Repair
Actual Study Start Date : January 19, 2015
Actual Primary Completion Date : February 17, 2017
Actual Study Completion Date : April 19, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Antibiotics prophylaxis cohort
Subjects were prescribed prophylactic antibiotics after the hypospadias 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.

Active Comparator: Antibiotic-sparing cohort
Subjects were not prescribed prophylactic antibiotics after the hypospadias surgery.
Other: Randomization to not receive prophylactic antibiotics after surgery.
No antibiotics were ordered after surgery.




Primary Outcome Measures :
  1. Prevalence of symptomatic UTI within 30 days post-surgery [ Time Frame: 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.


Secondary Outcome Measures :
  1. Evaluation of surgical site infections (SSIs) and complications of hypospadias repair [ Time Frame: 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 ]
    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.



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Ages Eligible for Study:   3 Months to 6 Years   (Child)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males undergoing hypospadias repair on their penis.
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275519


Locations
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United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Investigators
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Principal Investigator: Stephen Canon Arkansas Children's Hospital, Pediatric Urology

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Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03275519     History of Changes
Other Study ID Numbers: IRB# 203532
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arkansas Children's Hospital Research Institute:
distal hypospadias repair
urinary tract infection
prophylactic antibiotic use
Additional relevant MeSH terms:
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Hypospadias
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents