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Surgical Outcomes of Newly Trained ShangRing Circumcision Providers.

ABSTRACT: BACKGROUND:Devices can potentially accelerate scale-up of voluntary medical male circumcision in sub-Saharan Africa. Studies have demonstrated advantages of the ShangRing device over conventional circumcision. With the need to train providers rapidly for scale-up, concerns arise about the transferability of techniques and the expertise of new trainees. METHODS:We compared outcomes of ShangRing circumcisions conducted in Kenya by experienced providers (experience with more than 100 ShangRing circumcisions) and newly trained providers (trained in Kenya by the experienced providers before the study began). During training, trainees performed at least 7 ShangRing circumcisions and 3 removals. Newly trained providers received intermittent clinical mentoring initially during the study but otherwise conducted circumcisions on their own. RESULTS:Four hundred six and 115 ShangRing procedures were performed by the new trainees and the experienced providers, respectively. The mean duration of circumcisions was 6.2 minutes for both trained and experienced provider groups (P = 0.45), whereas the mean pain score (on an 11-point scale) was 2.5 and 3.2, respectively (P = 0.65). There was no difference in the proportion of participants healed by the day 42 visit (P = 0.13) nor in the incidence of moderate and severe adverse events observed (P = 0.16). Participants in both groups were equally satisfied with final wound cosmesis. DISCUSSION:Results demonstrate that the ShangRing circumcision technique is easy to learn and master. Newly trained providers can safely conduct ShangRing circumcisions in routine service settings. The ShangRing can facilitate rapid rollout of voluntary medical male circumcision for HIV prevention in sub-Saharan Africa.

SUBMITTER: Awori QD

PROVIDER: S-EPMC4936420 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

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Surgical Outcomes of Newly Trained ShangRing Circumcision Providers.

Awori Quentin D QD Lee Richard K RK Li Philip S PS Zulu Robert R Agot Kawango K Combes Stephanie S Simba Raymond O RO Hart Catherine C Lai Jaim Jou JJ Zyambo Zude Z Goldstein Marc M Feldblum Paul J PJ Barone Mark A MA

Journal of acquired immune deficiency syndromes (1999) 20160601

<h4>Background</h4>Devices can potentially accelerate scale-up of voluntary medical male circumcision in sub-Saharan Africa. Studies have demonstrated advantages of the ShangRing device over conventional circumcision. With the need to train providers rapidly for scale-up, concerns arise about the transferability of techniques and the expertise of new trainees.<h4>Methods</h4>We compared outcomes of ShangRing circumcisions conducted in Kenya by experienced providers (experience with more than 100 ...[more]

PMID: 27331584

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Project description:INTRODUCTION:Since 2011, Kenya has been evaluating ShangRing device for use in its voluntary medical male circumcision (VMMC) program according to World Health Organization (WHO) guidelines. Compared to conventional surgical circumcision, the ShangRing procedure is shorter, does not require suturing and gives better cosmetic outcomes. After a pilot evaluation of ShangRing in 2011, Kenya conducted an active surveillance for adverse events associated with its use from 2016-2018 to further assess its safety, uptake and to identify any operational bottlenecks to its widespread use based on data from a larger pool of procedures in routine health care settings. METHODS:From December 2017 to August 2018, HIV-negative VMMC clients aged 13 years or older seeking VMMC at six sites across five counties in Kenya were offered ShangRing under injectable local anesthetic as an alternative to conventional surgical circumcision. Providers described both procedures to clients before letting them make a choice. Outcome measures recorded for clients who chose ShangRing included the proportions who were clinically eligible, had successful device placement, experienced adverse events (AEs), or failed to return for device removal. Clients failing to return for follow up were sought through phone calls, text messages or home visits to ensure removal and complete information on adverse events. RESULTS:Out of 3,692 eligible clients 1,079 (29.2%) chose ShangRing; of these, 11 (1.0%) were excluded due to ongoing clinical conditions, 17 (1.6%) underwent conventional surgery due to lack of appropriate device size at the time of the procedure, 97.3% (1051/1079) had ShangRing placement. Uptake of ShangRing varied from 11% to 97% across different sites. There was one severe AE, a failed ShangRing placement (0.1%) managed by conventional wound suturing, plus two moderate AEs (0.2%), post removal wound dehiscence and bleeding, that resolved without sequelae. The overall AE rate was 0.3%. All clients returned for device removal from fifth to eleventh day after placement. CONCLUSION:ShangRing circumcision is effective and safe in the Kenyan context but its uptake varies widely in different settings. It should be rolled out under programmatic implementation for eligible males to take advantage of its unique benefits and the freedom of choice beyond conventional surgical MMC. Public education on its availability and unique advantages is necessary to optimize its uptake and to actualize the benefit of its inclusion in VMMC programs.

Project description:BACKGROUND:Attention has recently turned toward the use of device-assisted male circumcision to help scale up male circumcision services in sub-Saharan Africa, with increasing emphasis on younger age groups. We assessed the use of the ShangRing for circumcising the subset of boys aged 10 to 12 years who were enrolled in two randomized clinical trials in Kenya. METHODS:We performed a sub-analysis of outcomes in 197 boys aged 10 to 12 years; a subset who were enrolled in two randomized clinical trials to assess the use of the no-flip ShangRing circumcision technique in men and boys. One trial assessed spontaneous detachment vs. planned removal of the ShangRing 7 days post-circumcision. The second trial compared the use of topical vs. injectable anesthesia with ShangRing circumcision. Aside from baseline characteristics, data was collected and analyzed for each trial separately. RESULTS:All participants were successfully circumcised. Duration of circumcision, participants requiring a dorsal slit, rate of adverse events, time to complete wound healing, and participant satisfaction were similar between the two groups in each trial. Mean time required for spontaneous ShangRing detachment was 14.82±3.76 days. Topical anesthesia showed a significantly lower mean pain score at the time of application (0.64±1.71 vs. 1.55± 2.21, p = 0.03) as well as postoperatively (0.54±0.88 vs. 1.72±1.56, p<0.0001). Median dwell time of the topical anesthetic was 43 (IQR: 35.5-60) minutes, while the median time it took the injectable anesthetic to take effect was 2.04 (IQR: 1.72-3.09) minutes. CONCLUSION:No-flip ShangRing circumcision had a positive safety profile among young adolescent boys, specifically ages 10-12 years. The use of spontaneous device detachment and topical anesthesia with the procedure have shown promising outcomes in this age group. This may have the potential to further increase the acceptability of ShangRing circumcision, and therefore accelerate the scle up of male circumcision services in sub-Saharan Africa. TRIAL REGISTRATION:ClinicalTrials.gov registration # NCT02390310.

Project description:Male circumcision is a proven prevention strategy against the spread of HIV. The World Health Organization's new 2016-2021 strategic framework on voluntary medical male circumcision (VMMC) targets 90% of males aged 10-29 years to receive circumcision by 2021 in 14 priority sub-Saharan countries while anticipating an increase in the demand for infant circumcision. It also states that the use of circumcision devices is a safe and efficient innovation to accelerate attainment of these goals. The primary objective of this pilot study was to evaluate the safety and acceptability of the ShangRing, a novel circumcision device, in boys below 18 years of age.A total of 80 boys, 3 months to 17 years old, were circumcised using the no-flip ShangRing technique. All rings were removed 5-7 days later. Participants were evaluated weekly until the wound was completely healed. Data on procedure times, adverse events (AEs), time to clinical wound healing and satisfaction were recorded and analysed.Nearly all (79/80, 98.8%) circumcisions were successfully completed using the no-flip ShangRing technique without complications. In one (1.2%) case, the outer ring slipped off after the foreskin was removed and the procedure was completed by stitching. The mean circumcision and ring removal times were 7.4 ± 3.2 and 4.4 ± 4.2 min, respectively. There were four (5%) moderate AEs, which were managed conservatively. No severe AEs occurred. The mean time to complete clinical healing was 29.8 ± 7.3 days. Participants or their parents liked ShangRing circumcision because it improved hygiene, was quick and possessed an excellent cosmetic appearance. Most (72/80, 94.7%) were very satisfied with the appearance of the circumcised penis, and all (100%) said they would recommend circumcision to others.Our results suggest that no-flip ShangRing VMMC is safe and acceptable in boys below 18 years of age. Our results are to be compared those seen following ShangRing VMMC in African men. Further study with larger sample sizes are needed to explore the scalability of the ShangRing in larger paediatric cohorts in Africa. We believe that the ShangRing has great potential for use in all age groups from neonates to adults, which would simplify device implementation.

Project description:BackgroundUse of medical devices represents a unique opportunity to facilitate scale-up of early infant male circumcision (EIMC) across sub-Saharan Africa. The ShangRing, a circumcision device prequalified by WHO, is approved for use in adults and adolescents and requires topical anaesthesia only. We aimed to investigate the safety and efficacy of the ShangRing versus the Mogen clamp for EIMC in infants across eastern sub-Saharan Africa.MethodsIn this multicentre, non-inferiority, open-label, randomised controlled trial, we enrolled healthy male infants (aged <60 days), with a gestational age of at least 37 weeks and a birthweight of at least 2·5 kg, from 11 community and referral centres in Kenya, Tanzania, and Uganda. Infants were randomly assigned (1:1) by a computer-generated text message service to undergo EIMC by either the ShangRing or the Mogen clamp. The primary endpoint was safety, defined as the number and severity of adverse events (AEs), analysed in the intention-to-treat population (all infants who underwent an EIMC procedure) with a non-inferiority margin of 2% for the difference in moderate and severe AEs. This trial is registered with Clinical.Trialsgov, NCT03338699, and is complete.FindingsBetween Sept 17, 2018, and Dec 20, 2019, a total of 1420 infants were assessed for eligibility, of whom 1378 (97·0%) were enrolled. 689 (50·0%) infants were randomly assigned to undergo EIMC by ShangRing and 689 (50·0%) by Mogen clamp. 43 (6·2%) adverse events were observed in the ShangRing group and 61 (8·9%) in the Mogen clamp group (p=0·078). The most common treatment-related AE was intraoperative pain (Neonatal Infant Pain Scale score ≥5), with 19 (2·8%) events in the ShangRing and 23 (3·3%) in the Mogel clamp group. Rates of moderate and severe AEs were similar between both groups (29 [4·2%] in the ShangRing group vs 30 [4·4%] in the Mogen clamp group; difference -0·1%; one-sided 95% CI upper limit of 1·7%; p=0·89). No treatment-related deaths were reported.InterpretationUse of the ShangRing device for EIMC showed safety, achieved high caregiver satisfaction, and did not differ from the Mogen clamp in other key measures. The ShangRing could be used by health systems and international organisations to further scale up EIMC across sub-Saharan Africa.FundingBill & Melinda Gates Foundation.

Project description:ObjectivesTo assess the safety, effectiveness, and acceptability of providing a reduced number of ShangRing sizes for adult voluntary medical male circumcision (VMMC) within routine service delivery in Lusaka, Zambia.MethodsWe conducted a randomized controlled trial and enrolled 500 HIV-negative men aged 18-49 years at 3 clinics. Participants were randomized to 1 of 2 study arms (Standard Sizing arm vs Modified Sizing arm) in a 1:1 ratio. All 14 adult ShangRing sizes (40-26 mm inner diameter, each varying by 1 mm) were available in the Standard Sizing arm; the Modified Sizing arm used every other size (40, 38, 36, 34, 32, 30, 28 mm inner diameter). Each participant was scheduled for 2 follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement), when they were evaluated for adverse events (AEs), pain, and healing.ResultsFour hundred and ninety-six men comprised the analysis population, with 255 in the Standard Sizing arm and 241 in the Modified Sizing arm. Three men experienced a moderate or severe AEs (0.6%), including 2 in the Standard Sizing arm (0.8%) and 1 in the Modified Sizing arm (0.4%). 73.2% of participants were completely healed at the scheduled day 42 healing check visit, with similar percentages across study arms. Virtually all (99.6%) men, regardless of study arm, stated that they were very satisfied or satisfied with the appearance of their circumcised penis, and 98.6% stated that they would recommend ShangRing circumcision to family/friends.ConclusionsThe moderate/severe AE rate was low and similar in the 2 study arms, suggesting that provision of one-half the number of adult device sizes is sufficient for safe service delivery. Effectiveness, time to healing, and acceptability were similar in the study arms. The simplicity of the ShangRing technique, and its relative speed, could facilitate VMMC program goals. In addition, sufficiency of fewer device sizes would simplify logistics and inventory.

Dataset Information

Surgical Outcomes of Newly Trained ShangRing Circumcision Providers.

Publications

Surgical Outcomes of Newly Trained ShangRing Circumcision Providers.

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