Shang Ring facilitates widespread circumcision in Africa
An African study has shown that a male circumcision device has several advantages over conventional surgical circumcision.
August 3, 2012 (Washington, DC) — An African study has shown that a male circumcision (MC) device has several advantages over conventional surgical circumcision.
The results were presented here at the AIDS 2012: XIX International AIDS Conference by one of the researchers, Quentin Awori, MBChB, from EngenderHealth in Kisumu, Kenya. Dr. Awori reported that the Shang Ring is easier and faster to use, and could make MC more widespread in Africa, thereby reducing the risk for HIV infection. Previous studies have shown that MC can reduce the risk for heterosexual transmission by about 60%.
The device, which consists of 2 concentric rings, is easier to use than conventional MC surgery, which requires a high level of technical skill. The field is prepared with surgical scrub solution, an inner ring is slipped over the shaft of the penis, the foreskin is everted over it, and local anesthetic is injected around the circumference of the base of the penis. Then the outer ring is attached over the inner ring and the foreskin, and the foreskin is cut away. The area is bandaged; no sutures are required. Most health professionals, not only surgeons, can be trained to use the device, which makes it attractive for use in low-resource settings.
After 7 days, the outer ring is removed, the inner ring is separated from the scab and removed, and the area is bandaged. The entire procedure takes less time than conventional surgical MC.
Dr. Awori conducted a randomized clinical trial to compare the Shang Ring with conventional MC at a site in Kenya (Shang Ring, n = 97; conventional MC, n = 103) and a site in Zambia (Shang Ring, n = 100; conventional MC, n = 98). The mean age of the Kenyan patients was 20.9 years and of the Zambian patients 24.1 years. In Kenya, 84.5% of the patients were single and in Zambia, 80.3% were.
There were no statistically significant differences in pain, measured on a visual analogue scale, between the 2 techniques. The 1-hour postoperative mean pain scores with the ring were 4.1 in Kenya and 3.6 in Zambia, compared with 3.6 and 3.1, respectively, for conventional MC. On day 2, the highest mean pain score was 1.1.
The estimated mean time to healing from the initial procedure was 44.1 days with the ring and 38.9 days with conventional MC (difference, 5.2 days; 95% confidence interval, 2.7 to 7.8 days; P < .001). But Dr. Awori explained that these figures are rough estimates. The last 4 study visits took place on days 21, 28, 32, and 60. If there had been a study visit around day 44, the mean time to healing with the ring procedure, the average length of time to healing reported might have been shorter, he said.
On day 42, 76.3% of patients who underwent the ring procedure were healed, as were 85.3% of patients who underwent conventional MC.
Adverse events rates for the ring and conventional procedures were similar (3.6% vs 3.5%). The most common adverse event in both procedures was wound dehiscence; however, because no sutures are used with the Shang Ring, a modified definition of dehiscence was used.
The total time for the 2 ring procedure visits was about half the time for the conventional MC procedure.
The first ring procedure takes about 7 minutes and removal of the ring takes about 3 minutes; the conventional procedure takes about 20 minutes (P < .001 at both trial sites).
Of the 2 physicians and 4 nonphysicians performing the procedures, 5 considered the ring procedure "much easier" and 1 considered it "easier" to use. Similarly, 5 had a "strong preference" for the ring and 1 had a "slight preference" for it.
In Kenya, 95.7% of ring patients and 85.9% of conventional MC patients were "very satisfied" with the cosmetic results of their procedure (P < .02). In Zambia, 96.8% and 71.3%, respectively, were "very satisfied" (P < .001). A slightly different technique for conventional MC was used in Zambia.
Given the low pain scores, low adverse-effect rates, time advantage, provider preference, and patient satisfaction with the ring procedure, Dr. Awori believes that the Shang Ring could facilitate a scale-up of voluntary MC in Africa.
Session moderator Jason Reed, MD, MPH, senior technical advisor for male circumcision programming at the Office of the Global AIDS Coordinator, US Department of State, in Washington, DC, told Medscape Medical News that "with the Shang Ring, the most significant findings are the time savings," which is important when offering widespread voluntary medical MC to a population. "We're trying to save...minutes so that we can enable a single provider...to do more," Dr. Reed explained.
Still, HIV testing and counseling, information about the benefits and risks of MC, and informed consent are required. "We don't have a tremendous shortage of lay counselors who can provide the HIV testing and counseling component, and where we do, we can fairly easily train them," Dr. Reed said. "The real human resource constraint is in credentialed nurses and physicians.... If device-based services were available and many, many more people could receive the device in a given day by a given provider team, then we would obviously need to increase the number of lay counselors or credentialed HIV testing and counseling staff to take care of that extra volume."
The study received no commercial funding. Dr. Awori and Dr. Reed have disclosed no relevant financial relationships.
By Daniel M. Keller, PhD
AIDS 2012: XIX International AIDS Conference: Abstract TUAC0404. Presented July 24, 2012.