Clinical application of a new device for minimally invasive circumcision.

Department of Sexual Medicine, Yijishan Hospital, Wannan Medical College, Wuhu 241001, China.
Asian Journal of Andrology (Impact Factor: 2.53). 06/2008; 10(3):447-54. DOI: 10.1111/j.1745-7262.2008.00411.x
Source: PubMed

ABSTRACT To study the clinical effects of a disposable circumcision device in treatment of male patients of different ages with either phimosis or excess foreskin.
One thousand two hundred patients between the age of 5 and 95 years underwent circumcision using this procedure in the 2-year period between October 2005 and September 2007. Of these cases, 904 had excess foreskin and 296 were cases of phimosis.
In 96.33% of the cases the incision healed, leaving a minimal amount of the inner foreskin with no scarring and producing good cosmetic results. There were no incidents of device dislocation or damage to the frenulum. The average operative time was 2.5 min for excess foreskin, and 3.5 min for phimosis. During the 7 days of wearing the device, mild to moderate edema occurred in 10.08% of cases with excess foreskin and in 2.58% of those with phimosis. Edema in the frenulum was seen in 1.67% of patients, and only 0.67% had an infection of the incision. A total of 86.25% of patients reported pain due to penile erection. After removal of the device, 0.58% of the cases had minimal bleeding around the incision, and 2.42% had wound dehiscence.
The new device can be applied to an overwhelming majority of patients with phimosis and excess foreskin. This technique is relatively simple to perform, and patients who underwent this surgery had very few complications. Antibiotics were not required and patients reported less pain than those who were circumcised using conventional methods. Circumcision with this device requires minimal tissue manipulation, and is quicker and safer than circumcision using conventional techniques.

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    ABSTRACT: Background We evaluated the safety and efficacy of a novel disposable male circumcision (MC) device developed by Jiangxi-Yuansheng-Langhe Medical Instrument Co., Ltd. Material/Methods Adult male patients (n=120; mean age, 26.6 years) with redundant foreskin and/or phimosis were included in a randomized, multicenter pilot clinical trial from October 2011 to February 2012. Patients were divided into 2 groups and subjected to MC with a novel disposable device (Device Group) (n=60) or to conventional dissection technique (CDT) (Control Group) (n=60). Intraoperative bleeding, surgery duration, pain, healing, and satisfaction with penis appearance were assessed. Adverse events (AEs) were noted. Results Intraoperative bleeding volume [3.5±2.7 (15–35) ml vs. 13.1±6.1 (4–25) ml] and mean surgical time [7.6±4.5 (2–23) min vs. 23.6±4.4 (15–35) min] in the Device Group were significantly less than in the Control Group (P<0.01). No AEs were observed in either group. There were no significant differences in postoperative pain, healing, or satisfaction with penis appearance between groups (P>0.05). Conclusions This novel disposable circumcision device produced satisfactory preliminary adult MC results compared with CDT treatments. This device may be broadly used in men, such as those with phimosis, who are ineligible for CDT.
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    ABSTRACT: Most circumcisions in our environment are carried out in children for religious and cultural reasons. The PlastiBell device has been used for several decades, though some complications have been associated with its use. This study examines the safety and acceptability of the PlastiBell device, which was used in circumcision in the majority of patients studied. Fifty consecutive patients, who had circumcision at a private medical facility in Jos, Nigeria, over a 2 year period, were reported. Their ages, method of circumcision, size of PlastiBell device used, incidence of complications and acceptability of procedure to parents were documented. In this study, all patients below 42 days old had their circumcision done with the PlastiBell device. Complications seen with this device included hemorrhage in one patient following a slipped out device. In 49 (98%) of the patients, the mothers were satisfied with the outcome of the procedures. The PlastiBell device can be safely used for circumcisions in children below 42 days old.
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    ABSTRACT: To compare clinical profiles of Shang Ring versus conventional circumcisions. Parallel group open-label randomized controlled trial with one-to-one allocations in 2 sites. We enrolled HIV-negative men aged 18-54 years in Homa Bay, Kenya, and Lusaka, Zambia and followed them at 2, 7, 14, 21, 28, 42, and 60 days after Shang Ring versus conventional circumcision. We compared the duration of surgery, postoperative pain using a visual analog scale, adverse events rates, time to complete wound healing by clinical assessment, participant acceptability, and provider preferences between circumcision groups. We randomized 200 men to each group; 197 and 201 contributed to the Shang Ring and conventional surgery analyses, respectively. Adverse event rates were similar between groups. Pain scores at most time points were similar, however, the Shang Ring group reported higher scores for worst pain during erections (3.5 ± 1.9 vs. 2.3 ± 1.7; P < 0.001). Significantly more men were satisfied with the cosmetic appearance following Shang Ring male circumcision (MC), 95.7% versus 85.9% (P = 0.02) in Kenya, and 96.8% versus 71.3% (P < 0.01) in Zambia. Although median time to complete wound healing was 43 days in both groups, conventional circumcisions healed on average 5.2 days sooner (P < 0.001). Shang Ring procedures took one-third the time of conventional MC, 7 versus 20 minutes. All circumcision providers preferred the Shang Ring. Safety profiles of the 2 techniques were similar, all MC providers preferred the Shang Ring technique, and study participants preferred the Shang Ring's cosmetic results. The Shang Ring should be considered for adult MC as programs scale-up.
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