Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Children's Hospital and Health System Foundation, Wisconsin | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| No Antibiotics Group | No Intervention | Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Septra | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4-8 days post-operation |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Travis W Groth, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15118434 | Background | 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. | |
| 29780414 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Antibiotics Group | 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. |
| FG001 | No Antibiotics Group | Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Antibiotics Group | 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. |
| BG001 | No Antibiotics Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Out of the consented and randomized participants these were the patients that we were able to obtain a post Op Urine sample | Posted | Count of Participants | Participants | 4-8 days post-operation |
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Antibiotics Group | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator | Medical College of Wisconsin | 414-337-3441 | ebedjeti@mcw.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 16, 2013 | Oct 24, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D007021 | Hypospadias |
| ID | Term |
|---|---|
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| ID | Term |
|---|---|
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | No Antibiotics Group | Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal. |
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | No Antibiotics Group | Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal. | 0 | 32 | 0 | 32 | 0 | 32 |
Not provided
Not provided
Not provided
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009930 |
| Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |