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Minimally invasive, sutureless, adolescent male circumcision with topical anesthetic: a field trial of Unicirc, a single-use surgical instrument.

ABSTRACT: Background:Circumcision has been shown to reduce the rate of HIV transmission in Africa. It is most cost effective if performed in younger men. Surgical assist devices can increase the efficiency and potentially reduce the cost of performing circumcisions. Methods:We used the Unicirc disposable instrument to perform circumcisions in an outpatient primary care clinic. The trial was non-blinded. Circumcisions were performed under topical anaesthetic and the wound was sealed with cyanoacrylate tissue adhesive. The primary outcome was intraoperative duration; secondary outcomes were intraoperative and postoperative pain; adverse events (AEs); time to healing and patient satisfaction; and, cosmetic result. Results:A total of 82 adolescent boys (aged 10-15 years) were circumcised. The median intraoperative time was 10 minutes and the median blood loss was 1 mL. All wounds were healed by 4 weeks and cosmetic results were excellent. There were no AEs. Conclusions:Adolescent circumcision with Unicirc under topical anesthetic and wound sealing with cyanoacrylate tissue adhesive is safe, rapid, and heals by primary intention with excellent cosmetic results. It is cost effective and can be used for large scale programs.

SUBMITTER: Millard PS

PROVIDER: S-EPMC7214996 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Minimally invasive, sutureless, adolescent male circumcision with topical anesthetic: a field trial of Unicirc, a single-use surgical instrument.

Millard Peter S PS Goldstuck Norman N

Translational andrology and urology 20200401 2

<h4>Background</h4>Circumcision has been shown to reduce the rate of HIV transmission in Africa. It is most cost effective if performed in younger men. Surgical assist devices can increase the efficiency and potentially reduce the cost of performing circumcisions.<h4>Methods</h4>We used the Unicirc disposable instrument to perform circumcisions in an outpatient primary care clinic. The trial was non-blinded. Circumcisions were performed under topical anaesthetic and the wound was sealed with cya ...[more]

PMID: 32420158

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Project description:As countries scale up adult voluntary medical male circumcision (VMMC) for HIV prevention, they are looking ahead to long term sustainable strategies, including introduction of early infant male circumcision (EIMC). Although a number of devices for EIMC are prequalified by the World Health Organization, evaluation of additional devices can provide policy-makers and clinicians the information required to make informed decisions. We undertook a field evaluation of the safety and acceptability of the AccuCirc device in Kisumu County, Kenya.Procedures were performed by four trained clinicians in two public facilities. Participants were recruited from surrounding public health facilities through informational talks at antenatal clinics, maternity wards, and maternal neonatal child health clinics. Healthy infants ages 0-60 days, with no penile abnormality, without a family history of bleeding disorder, with current weight-for-age within -2 Z-scores of WHO growth standards, and whose mother was at least 16 years of age were eligible for EIMC. The procedure was performed after administration of a penile dorsal nerve block using 2% lidocaine and administration of Vitamin K. The mother was given post-operative instructions on wound care and asked to remain in the clinic with the baby for an observational period of one hour, during which a face-to-face questionnaire was administered.Of 1259 babies screened, 704 were enrolled and circumcised. Median age of the infants was 16 days (IQR: 7-32.5) and of the mothers was 26 years (IQR: 22-30). Median time for the procedure was 19 minutes (IQR: 15-23). There were no serious adverse events (AE), and 20 (2.8%) moderate AEs, all of which were due to bleeding that required application of one to three sutures. There were 22 (3.8%) procedures in which the device did not fully incise the entire circumference of the foreskin and had to be completed using sterile scissors. 89.9% of mothers had knowledge of EIMC, but few (8.1%) had any knowledge of devices used for EIMC. Protection against HIV/AIDS was the most cited reason to circumcise a baby (65.3%), while the baby being ill (38.1%) and pain (34.4%) were the most cited barriers to uptake. 99% of mothers were "very satisfied" or "completely satisfied" with the procedure.This evaluation of the AccuCirc device is the largest to date and indicates that the device is safe and acceptable, achieving high levels of parental satisfaction. The AccuCirc device should be considered for WHO prequalification to increase options for safe and sustainable provision of EIMC.

Project description:BackgroundTo investigate the changing circumcision rate in South Korea in the last decade and to propose underlying causes for this change, in the context of the present fluctuating world-wide trends in circumcision.MethodsFrom 2009 to 2011, 3,296 South Korean males (or their parents) aged 0-64 years were asked about their circumcision status, their age at circumcision, and their information level regarding circumcision. We employed non-probability sampling considering the sensitive questions on the study theme.ResultsCurrently the age-standardized circumcision rate for South Korean males aged 14-29 is found to be 75.8%. In an earlier study performed in 2002, the rate for the same age group was 86.3%. Of particular interest, males aged 14-16 show a circumcision rate of 56.4%, while the same age group 10 years ago displayed a much higher percentage, at 88.4%. In addition, the extraordinarily high circumcision rate of 95.2% found 10 years ago for the 17-19 age group is now reduced to 74.4%. Interestingly, of the circumcised males, the percentage circumcised in the last decade was only 25.2%; i.e., the majority of the currently circumcised males had undergone the operation prior to 2002, indicating that the actual change in the last decade is far greater. Consistent with this conjecture, the 2002 survey showed that the majority of circumcised males (75.7%) had undergone the operation in the decade prior to that point. Focusing on the flagship age group of 14-16, this drop suggests that, considering the population structure of Korean males, approximately one million fewer circumcision operations have been performed in the last decade relative to the case of non-decline. This decline is strongly correlated with the information available through internet, newspapers, lectures, books, and television: within the circumcised population, both the patients and their parents had less prior knowledge regarding circumcision, other than information obtained from person to person by oral communication. Within the uncircumcised population, the prior knowledge was far greater, suggesting that information discouraging circumcision played an important role.ConclusionSouth Korean male circumcision is likely to be undergoing a steep decline. The cause for this decline seems to be the increase in information available on the pros and cons of circumcision.

Project description:IntroductionMonitoring clinical safety of voluntary medical male circumcision (VMMC) is critical to minimize risk as VMMC programs for HIV prevention are scaled. This cross-sectional analysis describes the adverse event (AE) profile of a large-scale, routine VMMC program and identifies factors associated with the development, severity, and timing of AEs to provide recommendations for program quality improvement.Materials and methodsFrom 2015-2018 there were 28,990 circumcisions performed in International Training and Education Center for Health (I-TECH) supported regions of Namibia in collaboration with the Ministry of Health and Social Services. Two routine follow-up visits after VMMC were scheduled to identify clients with AEs. Summary statistics were used to describe characteristics of all VMMC clients and the subset who experienced an AE. We used chi-square tests to evaluate associations between AE timing, patient age, and other patient and AE characteristics. We used a logistic regression model to explore associations between patient characteristics and AE severity.ResultsOf the 498 clients with AEs (AE rate of 1.7%), 40 (8%) occurred ≤2 days, 262 (53%) occurred 3-7 days, 161 (32%) between day 8 and 14, and 35 (7%) were ≥15 days post-VMMC. Early AEs (on or before day 2) tended to be severe and categorized as bleeding, while infections were the most common AEs occurring later (p<0.001). Younger clients (aged 10-14 years) experienced more infections, whereas older clients experienced more bleeding (p<0.001).ConclusionsAlmost 40% of AEs occurred after the second follow-up visit, of which 179 (91%) were infections. Improvements in pre-surgical and post-surgical counselling and post-operative educational materials encouraging clients to seek care at any time, adoption of alternative follow-up methods, and the addition of a third follow-up visit may improve outcomes for patients. Enhancing post-surgical counselling and emphasizing wound care for younger VMMC clients and their caregivers could help mitigate elevated risk of infection.

Dataset Information

Minimally invasive, sutureless, adolescent male circumcision with topical anesthetic: a field trial of Unicirc, a single-use surgical instrument.

Publications

Minimally invasive, sutureless, adolescent male circumcision with topical anesthetic: a field trial of Unicirc, a single-use surgical instrument.

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