What is this research study about?
This is a multi-institutional study to find out if children benefit from taking prophylactic (preventive) antibiotics after hypospadias repair. We’re calling it the PROPHY Study. Centers currently participating in the study are Lurie Children’s (Chicago) and The Hospital for Sick Children (SickKids) in Toronto, Canada.
This study is a randomized trial – the highest quality of research study available. It compares the outcomes of children who receive preventive antibiotics for 10 days after hypospadias surgery with those who receive a placebo.
Why is the study important?
Recent research suggests that preventive antibiotics do not reduce the already low risk of infection or other problems after hypospadias surgery. Older studies, however, found antibiotics to be beneficial. Unfortunately, none of these studies was of sufficient quality to provide a definite answer.
Antibiotics may cause allergic reactions, diarrhea and other side effects like bacterial resistance, which makes future infections difficult to treat. Therefore, if antibiotics don’t improve the outcomes of hypospadias surgery, it would be best to avoid using them.
What is a randomized trial?
Randomization means that a computer chooses the study medication for each patient in a way similar to flipping a coin. There is an equal chance of receiving either the antibiotic or the placebo.
Enrollment in the study does not change the type of surgery or other care each child receives. If any child involved in the study does develop an infection, he will be switched from the study medication to a different antibiotic.
What is the placebo?
The placebo does not contain active ingredients but otherwise looks and tastes exactly like the antibiotic. This way, patients, parents and physicians are unaware of which one the participant is taking until after the study is complete.
How much does it cost?
There is no cost to participate. The study medication (antibiotic or placebo) is paid for by the study. Participants and/or their insurance are still responsible for all other costs of medical care (surgery, clinic visits, etc.).
What do we need to do to participate?
Families who are interested in participating need to have a 10-15 minute telephone conversation with a study coordinator prior to the day of surgery.
After surgery, participants take the study medication for 10 days. There are no extra appointments. Follow up visits are scheduled at 5-10 days, one month and six months post-operatively. There is also a brief survey of each family five years after the procedure.
When will the study be complete?
We hope to finish enrolling patients in 2017. The results will be published twice – when all participants have completed six months and five years of follow-up.
Who is eligible?
To participate in this research study, boys who have hypospadias surgery must:
- Be younger than 6 years old
- Not have had previous hypospadias surgery
- Not have medical conditions that can increase risk of infection
- Not be allergic to trimethoprim-sulfamethoxazole (Bactrim) or other sulfa drugs
- Not receive antibiotics within seven days prior to surgery
Study Personnel & Contact Information
Study Coordinator - Lurie Children's
Primary & Co-Investigators
Earl Y. Cheng, MD - Primary Investigator, Lurie Children’s
Dr. Cheng is the Head of the Division of Urology. He is board-certified in pediatric urology. Dr. Cheng completed his urology residency at Northwestern University and his pediatric urology fellowship at Children’s Memorial Hospital. He is currently Professor of Urology at Northwestern University’s Feinberg School of Medicine. He is a national expert in complex reconstructive urology and has a special interest in the medical and surgical management of individuals with sex development conditions. He also co-directs a basic science laboratory with Arun Sharma, PhD, that focuses on tissue engineering techniques for the urinary tract.
Mark A. Faasse, MD - Co-Investigator, Advocate Children's
Dr. Faasse is a urologist at Advocate Children’s Medical Group in Chicago. He completed his fellowship in Pediatric Urology at Lurie Children’s. He graduated from the University of Michigan Medical School and completed residency training in Urology at the University of Illinois at Chicago. His interests include antibiotic stewardship, increasing operating room efficiency, hypospadias repair and robotic surgery.
Walid A. Farhat, MD - Co-Investigator, SickKids
Dr. Farhat is a urologist at The Hospital for Sick Kids. He completed his medical degree at the American University of Beirut and completed his fellowship in clinical research at The Hospital for Sick Children, where he is now an associate professor. His interests include hypospadias-related research, minimally invasive surgery, pediatric voiding dysfunction and vesicoureteral reflux.
Dennis B. Liu, MD - Co-Investigator, Lurie Children’s
Dr. Liu is an attending physician in the Division of Urology. He graduated from the Feinberg School and completed his fellowship in pediatric urology at Children's Memorial Hospital. He is board-certified in pediatric urology. His interests include hypospadias, undescended testicles, genital/urinary tract reconstruction and renal and ureteral anomalies.
This study is supported by a grant from the Children’s Hospital of Chicago Faculty Practice Plan, as well as the Divisions of Urology at Lurie Children’s and SickKids.