An easy-to-use device for infant circumcision has been shown to be safe in an international randomized controlled clinical trial conducted by physician-researchers at Weill Cornell Medicine. The findings suggest that the device could boost efforts to increase circumcision rates and prevent HIV in low-resource settings where early infant circumcision is not widespread.
The trial, whose results were published Sept. 13 in Lancet Global Health, compared a device called the ShangRing with the current gold standard circumcision device called the Mogen clamp in infants. The trial took place in Kenya, Tanzania and Uganda and found the ShangRing to be as safe as the old tool.
“Voluntary medical male circumcision reduces the risk of HIV transmission by half to two thirds. It also reduces the risk of transmission of other sexually transmitted diseases,” said lead author Dr. Richard Lee, associate professor of urology and clinical researcher Nanette Laitman in population health sciences/community health at Weill Cornell. Medicine and urologist at NewYork-Presbyterian/Weill. Cornell Medical Center. “Early infant circumcision is simpler and has several other advantages over circumcision of adolescents or adult males, such as faster wound healing, no need to miss work, and less risk and complications.”
Study co-investigator and corresponding author of this report, Dr. Philip Li, research professor of urology and reproductive medicine at Weill Cornell Medicine, discovered the ShangRing device, invented by Jian-Zhong Shang, during a a trip to China more than ten years ago. It uses two concentric plastic rings to sandwich the foreskin allowing a practitioner to cut away excess skin with minimal bleeding and without stitches. The procedure can be performed under local anesthesia and takes less than 5 minutes.
“We were looking for a device that would speed up task shifting from physicians to non-physicians and reduce the need for extensive surgical training,” Dr. Li explained. nurses and doctors to perform voluntary medical male circumcisions (VMMC) in Africa.”
It was immediately apparent that the ShangRing was a “game changer,” said study co-author Dr. Marc Goldstein, Matthew P. Hardy, Ph.D. Professor Emeritus of Reproductive Medicine and urology at Weill Cornell Medicine and director of the Center for Male Reproductive Medicine and Microsurgery at NewYork-Presbyterian/Weill Cornell Medical Center. He said that in addition to having minimal training requirements, the ShangRing disposable device is pre-sterilized, reducing the time, cost and resources needed to sterilize reusable circumcision devices, such as the Mogen clamp. .
With seed funding from Weill Cornell Medicine and grants from the Bill & Melinda Gates Foundation and the National Institutes of Health, Weill Cornell Medicine researchers initiated a series of clinical trials of the ShangRing device in sub-Saharan Africa, in starting with men, then teenagers. , and now infants.
In the latest study, 1420 healthy infants in Kenya, Tanzania and Uganda were randomized to be circumcised with the ShangRing or the Mogen forceps. Nurses or medical advisors, who went through a training protocol with both devices before the study, performed almost all of the procedures. All infants received a rectal acetaminophen suppository, a topical anesthetic, and a sugary liquid for pain relief. Infants in both groups had similar rates of adverse events and post-surgical pain. Ninety-seven percent of parents or guardians of infants said they were satisfied with the procedure and its results.
“The safety profile combined with high parental satisfaction makes ShangRing a device that could be used by health systems and international organizations to scale up early male circumcision services in sub-Saharan Africa,” said lead author, Dr. Spyridon Basourakos, Senior Clinical Associate in Urology at Weill Cornell Medicine and Chief Urology Resident at NewYork-Presbyterian/Weill Cornell Medical Center.
The next steps for the team will be to expand the implementation of the use of the ShangRing for VMMC in Africa. The ShangRing is currently the only World Health Organization prequalified male circumcision device used in VMMC in Africa for men aged ten years and older. Dr. Li said around 2 million adult and adolescent men have safely undergone the ShangRing procedure worldwide.
“This is a major step forward in our fight against sexually transmitted diseases,” said Dr. Goldstein.
Many physicians and scientists at Weill Cornell Medicine maintain relationships and collaborate with external organizations to foster scientific innovation and provide expert advice. The institution makes this information public for the sake of transparency. For this information, see the profiles for Dr. Marc Goldstein and Dr Richard. Lee.