An easy-to-use infant circumcision device was proven safe in an international randomized controlled clinical trial led by Weill Cornell Medicine physician-scientists. The results suggest that the device could enhance efforts to increase circumcision rates and prevent HIV in under-resourced settings where early infant circumcision is not common.
The trial, the results of which were published Sept. 13 in the Lancet Global Health, compared a device called the ShangRing to the current gold-standard circumcision device called the Mogen clamp in infants. The experiment was conducted 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 the senior author Dr. Richard LeeNanette Lightman, associate professor of urology and clinical researcher in population health sciences/community health at Weill Cornell Medicine and a urologist at NewYork-Presbyterian/Weill Cornell Medical Center. “Early infant circumcision is simpler and has many other benefits over circumcision of adolescents or adult men, such as faster wound healing, no need to take time off from work, and reduced risks and complications.”
Study co-author and corresponding author of this report, Dr. Philip LeeThe ShangRing device, invented by Jian-Zhong Shang, was discovered by a research professor of urology and reproductive medicine at Weill Cornell Medicine during a trip to China more than a decade ago. Two concentric plastic rings are used to cut the foreskin allowing the practitioner to cut away the excess skin with minimal bleeding and without stitches. The operation can be performed under local anesthesia and takes less than 5 minutes.
“We were looking for a device that would speed up the shift of tasks from physicians to non-physicians and reduce the need for extensive surgical training,” explained Dr. Lee. “Countries with limited numbers of urologists and surgeons rely heavily on nurses and medical staff to perform voluntary medical male circumcision (VMMC) in Africa.”
A study co-author said it was immediately clear that ShangRing was a “game changer.” Dr. Mark Goldstein, Matthew B. Hardy, Ph.D. Distinguished Professor of Reproductive Medicine and Urology at Weill Cornell Medicine and Director of the Center for Male Reproductive Medicine and Microsurgery at New York Presbyterian/Weill Cornell Medical Center. In addition to the minimum training requirements, he said, the disposable ShangRing device comes pre-sterilized, reducing the time, costs and resources needed to sterilize reusable excision devices, such as the Mogen clip.
With initial funding from Weill Cornell Medicine and grants from the Bill & Melinda Gates Foundation and the National Institutes of Health, Weill Cornell Medicine investigators have launched a series of clinical trials of the ShangRing device in sub-Saharan Africa, starting with men, then adolescents and now infants.
In the latest study, 1,420 healthy infants in Kenya, Tanzania and Uganda were randomly selected to be circumcised with either the ShangRing or Mogen clamp. Nurses or medical officials, who underwent a training protocol with both devices prior to the study, performed nearly all of the procedures. All children received an acetaminophen rectal suppository, a local anesthetic, and a diabetic liquid for pain relief. Infants in both groups had similarly low rates of adverse events and postoperative pain. Ninety-seven percent of children’s parents or legal representatives reported that they were happy with the procedure and its results.
“The safety profile combined with high parental satisfaction makes the ShangRing a device that health care systems and international organizations can use to expand early infant male circumcision services in sub-Saharan Africa,” said the lead author. Dr.. Spyridon Basurcusa senior clinical assistant in urology at Weill Cornell Medicine and chief of urology at NewYork-Presbyterian/Weill Cornell Medical Center.
The team’s next steps will expand the implementation of ShangRing’s use of VMMC in Africa. The ShangRing is currently the only WHO pre-qualified male circumcision device used in VMMC in Africa for males of ten years of age and older. Dr. Li said that around two million adult and teenage men have safely undergone Shang Ring operation worldwide.
“This is a huge advance in our fight against sexually transmitted diseases,” Dr. Goldstein said.
Many physicians and scientists at Weill Cornell Medicine maintain relationships and collaborate with outside organizations to advance scientific innovation and provide expert guidance. The Corporation publishes these disclosures to ensure transparency. For this information, see the profiles of Dr. Mark Goldstein And the Dr. Richard. Mine.