HypospadiasNCT02593903

Antibiotic Use Following Distal and Mid-shaft Hypospadias Repair

A study testing Septra in people with Hypospadias, run by Medical College of Wisconsin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the efficacy of prophylactic antibiotics following distal or mid-shaft hypospadias repair in influencing the rate of postoperative urinary tract infection and complications. Read more about this study

Who is it for?: Ages 6 months to 2 years, men only
Conditions the study is for: Hypospadias
What is being tested?: Septra
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 1 siteUnited States
Study dates: 4 Mar 2014to Apr 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 6 months to 2 years
Men only
No healthy volunteers
Child

Who may be able to join

all children between ages 6 months to 2 years under going distal or mid shaft hypospadias repair
children of parents who give informed consent
English speaking
participant must be available for follow-up 3 and 12 months post-surgery

Who cannot join

all proximal hypospadias and redo hypospadias repairs
children who are allergic to sulfa medications
patients who have UTI at time of surgery (proven by culture)

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

Official title: Prophylactic Antibiotics Following Distal/Mid-shaft Hypospadias Repair: Are They Necessary?

Read the detailed description

The rationale for using prophylactic antibiotics after hypospadias surgery is to decrease the occurrence of urinary tract infections (UTIs) and complications. However, even though prophylactic antibiotics are used by some pediatric urologists, to date there has been no evidence supporting the role of prophylactic antibiotics in decreasing UTIs or complications. This is a prospective, randomized trial involving children undergoing distal or mid-shaft hypospadias repair. Subjects randomized into a group taking prophylactic dosages of antibiotics and a group not receiving post-operative antibiotics.

Conditions: Hypospadias
Being tested: Septra
Keywords: Antibiotic Prophylaxis
Medical subject headings: Hypospadias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SeptraDrug
Also called Bactrim, Sulfamethoxazole/trimethoprim

Study groups in NCT02593903
Study group	Role	What they receive
Antibiotics Group	Experimental	Patients randomized to this arm will receive prophylactic oral antibiotics following the surgery and catheter placement (Septra, 3 mg/kg/dose once daily), and will continue the medication for until the day before catheter removal 4-8 days post-operation. Receives: Drug: Septra
No Antibiotics Group	No intervention	Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal.

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Urinary Tract Infection
Urinary tract infection (UTI) will be diagnosed based on urine culture positive at 50,000CFUs per mL with one or both of the following: fever >38 Celsius, or significant fussiness and irritability with voiding per parent report. Asymptomatic bacteriuria is known and expected in this population; therefore culture positive results alone will not be sufficient to meet the definition of UTI.
Measured: 4-8 days post-operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Mar 2014Apr 2018

First posted2 Nov 2015 (estimated)
Study start4 Mar 2014
Primary completion30 Jun 2017
Study completionApr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HypospadiasStudies of the same condition, open and under way.
More trials run by Medical College of WisconsinThe sponsor's other registered studies.
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
Masking: Single blind
Who is masked: Investigator
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02593903
Sponsor's protocol ID: CHW 13/140
Status last verified: Nov 2018
First submitted: 30 Oct 2015
Last updated: 5 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Meir DB, Livne PM. Is prophylactic antimicrobial treatment necessary after hypospadias repair? J Urol. 2004 Jun;171(6 Pt 2):2621-2. doi: 10.1097/01.ju.0000124007.55430.d3.
PubMed 15118434
Roth EB, Kryger JV, Durkee CT, Lingongo MA, Swedler RM, Groth TW. Antibiotic Prophylaxis with Trimethoprim-Sulfamethoxazole versus No Treatment after Mid-to-Distal Hypospadias Repair: A Prospective, Randomized Study. Adv Urol. 2018 Mar 26;2018:7031906. doi: 10.1155/2018/7031906. eCollection 2018.
PubMed 29780414

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 4
Effect of Oxybutynin on Opioid Use After Urologic Surgery in Children
Ureteropelvic Junction Obstruction, Hypospadias
Recruiting
Worldwide Yearly Screening for Hypospadias
Hypospadias
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Active, not recruiting
Evaluating the Efficacy and Safety of Tranexamic Acid in Reducing Perioperative Bleeding During Recurrent Hypospadias Repair.
Perioperative Bleeding During Recurrent Hypospadias Repair
Not yet recruiting
Efficacy of PRF in Hypospadias Repair
Hypospadias

All Hypospadias trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prophylactic Antibiotics Following Distal/Mid-shaft Hypospadias Repair: Are They Necessary?
ClinicalTrials.gov ID: NCT02593903
Acronym / sponsor ID: CHW 13/140
Conditions: Hypospadias
Keywords: Antibiotic Prophylaxis
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Medical College of WisconsinUniversity, hospital or other
Collaborators: Children's Hospital and Health System Foundation, Wisconsin
Study start: 4 Mar 2014 (actual)
Primary completion: 30 Jun 2017 (actual)
Study completion: Apr 2018 (actual)
First posted: 2 Nov 2015 (estimated)
Results: Posted 5 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Antibiotics Group	Experimental	Drug: SeptraPatients randomized to this arm will receive prophylactic oral antibiotics following the surgery and catheter placement (Septra, 3 mg/kg/dose once daily), and will continue the medication for until the day before catheter removal 4-8 days post-operation.
No Antibiotics Group	No intervention	–Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal.

Who may qualify

Ages: 6 months to 2 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

all children between ages 6 months to 2 years under going distal or mid shaft hypospadias repair
children of parents who give informed consent
English speaking
participant must be available for follow-up 3 and 12 months post-surgery

Key exclusion criteria (3 listed)

all proximal hypospadias and redo hypospadias repairs
children who are allergic to sulfa medications
patients who have UTI at time of surgery (proven by culture)

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
SeptraAlso: Bactrim, Sulfamethoxazole/trimethoprim	Drug	Antibiotics Group

Primary outcome

Number of Participants With Urinary Tract Infection
Time frame: 4-8 days post-operation
Urinary tract infection (UTI) will be diagnosed based on urine culture positive at 50,000CFUs per mL with one or both of the following: fever >38 Celsius, or significant fussiness and irritability with voiding per parent report. Asymptomatic bacteriuria is known and expected in this population; therefore culture positive results alone will not be sufficient to meet the definition of UTI.

Results and safety

Results posted to the registry on 5 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Antibiotics Group	35	35
No Antibiotics Group	32	31

Primary outcome: Number of Participants With Urinary Tract Infection

Time frame: 4-8 days post-operation. Count of participants. Unit: Participants

Measure	Antibiotics Group n = 30	No Antibiotics Group n = 22
Post Op Urine Sample obtained	30	22
clinical UTI	0	0

Population analysed: Out of the consented and randomized participants these were the patients that we were able to obtain a post Op Urine sample

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Antibiotics Group	0 of 35 (0%)	0 of 35 (0%)	0 of 35
No Antibiotics Group	0 of 32 (0%)	0 of 32 (0%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15118434Meir DB, Livne PM. Is prophylactic antimicrobial treatment necessary after hypospadias repair? J Urol. 2004 Jun;171(6 Pt 2):2621-2. doi: 10.1097/01.ju.0000124007.55430.d3.
Derived from this study: PubMed 29780414Roth EB, Kryger JV, Durkee CT, Lingongo MA, Swedler RM, Groth TW. Antibiotic Prophylaxis with Trimethoprim-Sulfamethoxazole versus No Treatment after Mid-to-Distal Hypospadias Repair: A Prospective, Randomized Study. Adv Urol. 2018 Mar 26;2018:7031906. doi: 10.1155/2018/7031906. eCollection 2018.

Related trials for Hypospadias

Not yet recruitingPhase 4
Effect of Oxybutynin on Opioid Use After Urologic Surgery in Children
Ureteropelvic Junction Obstruction, Hypospadias
Recruiting
Worldwide Yearly Screening for Hypospadias
Hypospadias
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Active, not recruiting
Evaluating the Efficacy and Safety of Tranexamic Acid in Reducing Perioperative Bleeding During Recurrent Hypospadias Repair.
Perioperative Bleeding During Recurrent Hypospadias Repair
Not yet recruiting
Efficacy of PRF in Hypospadias Repair
Hypospadias

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.

Travis W Groth, MD principal investigator

Medical College of Wisconsin

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Septra in people with Hypospadias, run by Medical College of Wisconsin 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 4 inclusion and 3 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 5 Nov 2018. 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?

Yes. Results are posted in the registry (first posted 5 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Urinary Tract Infection (time frame: 4-8 days post-operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02593903, which also lists 2 linked publications.

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 5 Nov 2018.