HypospadiasNCT03275519
Antibiotic Use in Distal Hypospadias Repair
A study testing Randomization to not receive prophylactic antibiotics after surgery. and Randomization to receive prophylactic antibiotics after surgery in people with Hypospadias, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 months to 6 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypospadias
- What is being tested?
- Randomization to not receive prophylactic antibiotics after surgery. and Randomization to receive prophylactic antibiotics after surgery
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2015to 19 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 6 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Males undergoing primary distal hypospadias repair with open urethral stent drainage.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
Official title: Randomized Trial of Antibiotic Prophylaxis for Prevention of Symptomatic UTI in Stented, Distal Hypospadias Repair
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.
Read the 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
- Being tested
- Randomization to not receive prophylactic antibiotics after surgery., Randomization to receive prophylactic antibiotics after surgery
- Keywords
- distal hypospadias repair, urinary tract infection, prophylactic antibiotic use
- Medical subject headings
- Hypospadias, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomization to not receive prophylactic antibiotics after surgery.Other
No antibiotics were ordered after surgery.
Randomization to receive prophylactic antibiotics after surgeryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics prophylaxis cohort | Active comparator | Subjects were prescribed prophylactic antibiotics after the hypospadias surgery. Receives: Other: Randomization to receive prophylactic antibiotics after surgery |
| Antibiotic-sparing cohort | Active comparator | Subjects were not prescribed prophylactic antibiotics after the hypospadias surgery. Receives: Other: Randomization to not receive prophylactic antibiotics after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days post surgery
Secondary outcomes (1)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start19 Jan 2015
- Primary completion17 Feb 2017
- Study completion19 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Canon, Principal investigator, Arkansas Children's Hospital, Pediatric Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275519
- Sponsor's protocol ID
- IRB# 203532
- Status last verified
- Sep 2017
- First submitted
- 11 Aug 2017
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Antibiotic Prophylaxis for Prevention of Symptomatic UTI in Stented, Distal Hypospadias Repair
- ClinicalTrials.gov ID
- NCT03275519
- Acronym / sponsor ID
- IRB# 203532
- Conditions
- Hypospadias
- Keywords
- distal hypospadias repair, urinary tract infection, prophylactic antibiotic use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 19 Jan 2015 (actual)
- Primary completion
- 17 Feb 2017 (actual)
- Study completion
- 19 Apr 2017 (actual)
- First posted
- 7 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Antibiotics prophylaxis cohort | Active comparator | Other: Randomization to receive prophylactic antibiotics after surgerySubjects were prescribed prophylactic antibiotics after the hypospadias surgery. |
| Antibiotic-sparing cohort | Active comparator | Other: Randomization to not receive prophylactic antibiotics after surgery.Subjects were not prescribed prophylactic antibiotics after the hypospadias surgery. |
Who may qualify
- Ages
- 3 months to 6 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Males undergoing primary distal hypospadias repair with open urethral stent drainage.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Randomization to not receive prophylactic antibiotics after surgery.No antibiotics were ordered after surgery. | Other | Antibiotic-sparing cohort |
| Randomization to receive prophylactic antibiotics after surgeryIn 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. | Other | Antibiotics prophylaxis cohort |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Canon principal investigator
Arkansas Children's Hospital, Pediatric Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Randomization to not receive prophylactic antibiotics after surgery. and Randomization to receive prophylactic antibiotics after surgery in people with Hypospadias, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of symptomatic UTI within 30 days post-surgery (time frame: 30 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2017.