Shang Ring Circumcision Research Articles

Comparative analysis on the outcomes in circumcising children using modified Chinese ShangRing and conventional surgical circumcision

To compare the differences and outcomes of surgical procedures, clinical effect, complications and patients' satisfaction between disposable oval-shaped circumcision device (Modified Chinese ShangRing series, Kiddie love®) and conventional circumcision in the treatment of children with phimosis or redundant prepuce. The clinical data were retrospectively analyzed in 114 children with phimosis or redundant foreskin undergone circumcision using a disposable oval-shaped circumcision device, a modified Chinese ShangRing series, Kiddie Love® (Kiddie Love group) in our hospital between January 2018 and February 2020, and another 114 children with similar conditions circumcised by conventional surgical procedure before January 2018 (conventional group). The two groups were compared regarding the operative time, intraoperative blood loss, postoperative pain scores, healing time, the incidence of complications and guardian's satisfaction. Circumcision was successfully completed in children in both groups. The operative time, intraoperative blood loss, postoperative pain scoring in 24h by VAS, pain at the removal of the device or stitches and wound healing were (6.4 ± 1.6) min, (34.1 ± 6.4) min; (0.7 ± 0.2) ml, (2.6 ± 0.6) ml; (2.2 ± 1.0) points, (1.3 ± 0.5) points; (23.7 ± 3.9)day, (15.9 ± 2.8)day, respectively for Kiddie Love group and conventional group(either P < 0.05 or P > 0.05). The two groups were significantly different in the incidence of hematoma, edema and incision dehiscenceyet were insignificant in incision infection. Children in both groups were followed up from 6 to 31months (mean: 23months), and the satisfaction rate was 94.7% (108/114) in parents of the children circumcised by the ShangRing and 83.3% (95/114) in those of children treated by conventional circumcision (P < 0.05). Modified Chinese ShangRing, Kiddie Love®, has superiorities, including simpler procedure, shorter operative time, less blood loss, fewer complications, better cosmetic results and higher satisfaction of patients over conventional circumcision in the treatment of children with phimosis or redundant foreskin, and worthy of wider clinical recommendation.

Acceptability of male circumcision for HIV prevention among men who have sex with men in China: a short report

ABSTRACT Recent evidence shows that circumcision is associated with lower HIV prevalence among MSM. We assessed the acceptability of circumcision for preventing HIV and that of Shang Ring circumcision (SRC) among men who have sex with men (MSM) in China. 538 adult MSM were recruited from six cities in China between January and March 2019. Participants were surveyed by an online, self-administered questionnaire. The acceptability of circumcision was assessed before and after the potential protective effect of circumcision against HIV was informed, and subsequently men’s willingness to undergo SRC was assessed. The level of circumcision was 16.4%. Of 450 uncircumcised MSM, their willingness to be circumcised in the following six months increased significantly from 32.2% to 55.6% after the information session. Three quarters of men who were willing to undergo circumcision accepted SRC. MSM who perceived that circumcision could maintain genital hygiene were more likely to accept circumcision after the information session, whereas those who regarded circumcision as an embarrassing surgery were disinclined to be circumcised. The low circumcision rate, along with its high acceptability in Chinese MSM, suggests a great potential benefit of circumcision intervention if proved effective. SRC might be a popular circumcision procedure in this population.

Rollout of ShangRing circumcision with active surveillance for adverse events and monitoring for uptake in Kenya.

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. 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. 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. 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.

Clinical curative effect analysis of disposable circumcision suture device Versus Shang Ring circumcision and Traditional circumcision

Objective To compare the efficacy and safety of disposable circumcision suture device (DCSD), ShangRing circumcision and traditional circumcision in the treatment of patients with redundant prepuce or phimosis. Methods All the 620 patients with redundant prepuce or phimosis were randomly divided into three groups: the DCSD group(n=280) and the ShangRing group(n=210) and the traditional circumcision group(n=130). Factors concerning efficacy and safety were compared. Results DCSD showed obvious advantages of the ShangRing and the traditional circumcision in operating time(6.1±0.8), (8.5±1.7), (30.1±0.5)min, intraoperatve blood soss (1.0±0.0), (1.0±0.0), (5.0±1.0)mL, wound healing time (14.5±1.5), (18.5±2.0), (13.5±1.5)d, postoperative pain score (1.94±1.08), (3.89±0.98), (4.20±0.58). The incidence of postoperative hematoma was 2.29%, 2.25%, 1.52%, and post operation edema rate was 8.04%, 25.89%, 30.89%.There was significant difference in above results (P<0.05). Conclusions DCSD has advantages of shorter operation and incision healing time, reduced postoperative pain score, and high appearance satisfaction.It should be widely used in clinical practice. Key words: Foreskin; Phimosis; Circumcision, Male

Simplifying the ShangRing technique for circumcision in boys and men: use of the no-flip technique with randomization to removal at 7 days versus spontaneous detachment.

To assess safety of the no-flip ShangRing male circumcision technique and to determine clinical course and safety of spontaneous detachment (i.e., allowing the device to fall off), we conducted a case series of no-flip ShangRing circumcision combined with a randomized controlled trial of removal 7 days postcircumcision versus spontaneous detachment at two health facilities in Kenya. The primary outcome was the safety of the no-flip technique based on moderate and severe adverse events (AEs) during the procedure and through 42-day follow-up. A main secondary outcome was clinical course and safety of spontaneous detachment. Two hundred and thirty males 10 years and older underwent no-flip circumcision; 114 randomized to 7-day removal and 116 to spontaneous detachment. All circumcisions were successfully completed. Overall 5.3% (6/114) of participants in the 7-day group and 1.7% (2/116) in the spontaneous group had an AE; with no differences when compared to the 3% AE rate in historical data from African studies using the original flip technique (P = 0.07 and P = 0.79, respectively). Overall 72.4% (84/116) of participants in the spontaneous group wore the ShangRing until it detached. Among the remaining (27.6%; 32/116), the ring was removed, primarily at the participants' request, due to pain or discomfort. There was no difference in AE rates (P = 0.169), visit day declared healed (P = 0.324), or satisfaction (P = 0.371) between randomization groups. The median time to detachment was 14.0 (IQR: 7–21, range: 5–35) days. The no-flip technique and spontaneous detachment are safe, effective, and acceptable to boys and men 10 years and older. Phimosis and penile adhesions do not limit successful ShangRing circumcision with the no-flip technique.

Disposable circumcision suture devices versus Shang ring circumcision for management of redundant prepuce or phimosis: A systematic review and meta-analysis

ObjectiveTo evaluate the clinic efficacy and safety of the disposable circumcision suture device (DCSD) and Shang ring circumcision (SRC) in the treatment of redundant prepuce or phimosis with a meta-analysis. Material and methodsElectronic databases including PubMed, Embase, Wan Fang, VIP, CNKI and CBM database were researched from inception to August 30, 2016 for relevant RCTs and prospective studies, the reference lists of the included studies were also searched manually. The risk ratios (RR) or mean difference (MD) with 95% confidence intervals (CI) as the effect sizes were calculated by the Revman 5.3 and stata12.0 software. ResultsTwelve RCTs or prospective studies were included with 3345 patients among which 1661 cases received DCSD treatment and 1684 SRC. Compared to the Shang ring circumcision treatment, the disposable circumcision suture device provided a significantly shorter operation time [MD=−0.94, 95%CI (−1.76, −0.12), P=0.02], lower pain scores [MD=−1.89, 95%CI (−2.72, −1.07), P<0.001], no stitch removal pain, better postoperative penile appearance [RR=1.10, 95%CI (1.04, 1.17), P=0.001], fewer complications [RR=0.42, 95%CI (0.32, 0.56), P<0.001] and shorter wound healing time [MD=−8.92, 95%CI (−10.79, −7.05), P<0.001]. Meanwhile, there is more intraoperative blood loss [MD=0.12, 95%CI (0.02, 0.22), P=0.02], and more treatment cost [MD=877.57, 95%CI (737.94, 1017.20); P<0.001]. ConclusionsBased on the results of our meta-analysis, DCSD is more effective and safer than SRC. Thus, it has the advantages of shorter operation time, lower pain scores, better postoperative penile appearance, fewer complication and shorter wound healing time. However, the results need additional high-quality multicenter RCTs to evaluate in the future.

Prospective Observational Study of the ShangRing Device for Adult Medical Male Circumcision in a Routine Clinical Setting in Malawi.

We evaluated the safety and acceptability of the ShangRing device for male circumcision during routine clinical service delivery in Namitete, Malawi. We conducted a prospective observational study enrolling 500 HIV-negative men ages 18 to 49 years at St. Gabriel's Hospital. Participants returned for two follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement). We assessed pain, adverse events (AEs), acceptability, and healing. 500 men were screened; 498 were circumcised using the ShangRing and comprised the analysis population. Seven participants (1.4%) experienced moderate AEs related to circumcision. 93% were judged to be completely healed at or before the day 42 visit; 6% were judged to be healed later than the day 42 visit; 5 participants (1.0%) were lost to follow-up. 98% of men stated they were very satisfied with the appearance of their circumcised penis, and 99.6% would recommend ShangRing circumcision to family/friends. Adult male circumcision using the ShangRing was safe with a low AE rate at this service delivery site. Acceptability factors were also favorable. Addition of the ShangRing device could be beneficial to achieving the goals of the circumcision program in Malawi.

Clinical application of disposable circumcision suture device (DCSD) versus ShangRing circumcision in male circumcision

Objectives To compare the efficacy and safety of disposable circumcision suture device (DCSD) and ShangRing circumcision in the tratment of patients with redundant prepuce or phimosis. Methods 180 patients with redundant prepuce or phimosis were randomly divided into two groups: the DCSD group (n=93) and the ShangRing group (n=87). Factors concerning efficacy and safety were compared. Results DCSD showed obvious advantages over the ShangRing in operating time [(6.36±1.09)min vs. (7.23±1.10) min], postoperative 24h pain score (1.94±1.08) vs.(2.89±0.98), postoperative 7d pain score (2.08±0.89) vs. (3.74±1.01), wound healing time [(18.44±3.58)d vs. (21.66±3.65)d], the incidence of wound dehiscence (2.2% vs. 11.5%), and overall satisfactory rate (86.0% vs. 73.6%). There was significant difference in above results (P 0.05). Conclusions DCSD has advantages of shorter operation and incision healing time, reduced postoperative pain score, and high appearance satisfaction. It should be widely used in clinical practice. Key words: Circumcision, Male; Surgical Staplers

Surgical Outcomes of Newly Trained ShangRing Circumcision Providers.

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.

Men's Understanding of and Experiences During the Postcircumcision Abstinence Period: Results From a Field Study of ShangRing Circumcision During Routine Clinical Services in Kenya and Zambia

Background:Men's understanding of counseling messages after voluntary medical male circumcision (VMMC) plays an important role in whether they follow them. Data on triggers for early resumption of sex may be useful as scale-up of VMMC for HIV prevention continues in sub-Saharan Africa.Methods:Data on understanding of post-VMMC abstinence recommendations, resumption of sex, condom use, and triggers for resuming sex were collected from participants during a follow-up interview 35–42 days after ShangRing circumcision in Kenya and Zambia.Results:Of 1149 men who had ShangRing circumcision, 1096 (95.4%) completed follow-up. Nearly all (99.2%) reported being counseled to abstain from sex post-VMMC; among those, most (92.2%) recalled the recommended abstinence period was 6 weeks. Most men (94.1%) reported that the counselor gave reasons for post-VMMC abstinence and recalled appropriate reasons. Few (13.4%) men reported resuming sex at 35–42 days' follow-up. Among those, 54.8% reported never using a condom post-VMMC. Younger participants (odds ratio 0.3, 95% confidence interval: 0.2 to 0.5, P < 0.0001) and those reporting at least some condom use at baseline (odds ratio 0.5, 95% confidence interval: 0.3 to 0.7, P = 0.0003) were less likely to report resuming sex. Among men who reported some condom use, most (71.5%) said condoms were much easier or easier to use after circumcision. Men reported various reasons for early resumption of sex, primarily strong sexual desire (76.4%).Conclusions:Most men reported awareness of and adherence to the counseling recommendations for post-VMMC abstinence. A minority reported early resumption of sex, and, among those, condom use was low. Results could be used to improve post-VMMC counseling.

Randomized Controlled Trial of the ShangRing for Adult Medical Male Circumcision: Safety, Effectiveness, and Acceptability of Using 7 Versus 14 Device Sizes.

Objectives:To 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.Methods:We 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.Results:Four 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.Conclusions:The 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.

Longer-Term Follow-Up of Kenyan Men Circumcised Using the ShangRing Device.

ObjectivesTo ascertain clinical sequelae, client satisfaction and sexual behavior 2+ years after male circumcision using the ShangRing device.MethodsWe enrolled 199 men from the Kenya sites (Homa Bay district) participating in a 2012 study of the ShangRing device used in routine male circumcision services (N = 552). We enrolled men who had had the ShangRing placed successfully, and over-sampled men who had had an adverse event and/or were HIV-positive during the field study. In the present study, each participant was examined and interviewed by a study clinician, and penile photographs were taken to document longer-term cosmetic results and any abnormal findings.Results194 men were included in the analysis. The mean and median times between circumcision and the longer-term follow-up visit in this study were 31.8 and 32 months, respectively. Four men (2.1%) had signs/symptoms of a sexually transmitted infection (STI). Virtually all (99.5%) of the men were very satisfied with the appearance of their circumcised penis, and all would recommend a ShangRing circumcision to friends or family members. The most prevalent reported advantage of the circumcision was the ease of bathing and enhanced cleanliness of the penis (75.8%). 94.3% of the men did not cite a single negative feature of their circumcision. 87.5% of men reported more sexual pleasure post-MC, the most common reason being more prolonged intercourse. The majority of men (52.6%) reported one sexual partner post-MC, but more than a quarter of the men (28.1%) reported an increased number of partners post-MC. Less than half of the men (44.3%) reported using condoms half of the time or more, but the great majority of condom users stated that condom use was much easier post-MC, and 76.9% of users said they used condoms more after circumcision than before.ConclusionsThis study supports the safety and acceptability of ShangRing male circumcision during 2–3 years of follow-up. It should allay worries that the ShangRing procedure could lead to delayed complications later than the observation period of most clinical studies.Trial RegistrationClinicalTrials.gov NCT01567436

Comparative study of the circumcision techniques curative effect between circumcision suture device and Shang Ring

Objective To compare the clinical effectiveness among disposable circumcisionsuture device and Shang Ring in treating redundant prepuce and phimosis. Methods The clinical data of 224 cases of circumcisions done by disposable circumcision suture device(n= 112)and Shang Ring(n= 112) were retrospective1y analyzed.Operation time,intra-operational bleeding and postoperative complications among two techniques were compared. Results Disposable circumcision suture operation and Shang ring circumcision without significant difference in the operation time and intra-operational bleeding.There result was(6.1±0.8)min vs(6.5±1.7)min and(2.0±0.0)mL vs(1.8±0.0)m L(P> 0.05).The incidence of postoperative complications with incision pain rate was 21.43% vs 50.89%,infection rate was 14.29% vs 6.25%,frenum area incision edema rate was 8.04% vs 25.89%,and the postoperative hematoma and healing time was(8.0±1.7)d vs(14.0±1.2)d,the differences were statistically significant(P<0.05). Conclusion Each of two techniques has its own advantages and disadvantages.The treatment decision making should be a detailed description to the patients,we propose that school -age children should choose Shang Ring built-in method and the others should use disposable circumcision suture device depending on the situation. Key words: Circumcision; Shang Ring; Circumcision suture device

Effect of different wound coping method on circumcision healing for patients with Chinese Shang ring circumcision

Objective To compare different nursing methods impacting on the wound healing effects of circumcision for patients with Chinese Shang ring circumcision. Methods A total of 144 male patients with Chinese Shang ring circumcision were randomly divided into A and B group by coin tossing. The patients of A group received circumcised dressing to wrap wound with dressing change 3 times/week; the patients of B group had no dressing for wound to exposure wound and keep wound dry. Followed interviewed 2 months after operation, we compared the incision edema, the infection, rate of incision rupture, postoperative pain, wound healing time, satisfaction of incision appearance and so other indexes between two groups. Results The patients in the group B suffered less pain when erected in 2 weeks after operation (P 0.05). Conclusions To exposure the incision and keep it dry after Chinese Shang ring circumcision can minimize the level of pain and length of wound healing, and is worthy to promote. Key words: Circumcision, male; Incision healing; Incision dressing

V3-08 A SIMPLIFIED NO-FLIP SHANG RING CIRCUMCISION TECHNIQUE WITH TOPICAL (EMLA) ANESTHESIA IN ADOLESCENTS AND ADULTS

You have accessJournal of UrologyMale Voiding/Sexual Dysfunction/BPH/ Incontinence/Infection/Infertility1 Apr 2015V3-08 A SIMPLIFIED NO-FLIP SHANG RING CIRCUMCISION TECHNIQUE WITH TOPICAL (EMLA) ANESTHESIA IN ADOLESCENTS AND ADULTS Aaron Bernie, Yifeng Peng, Philip Li, Richard Lee, Chao Jia, Benhai Yang, Quentin Awori, Nian Qing Lu, Mark Barone, and Marc Goldstein Aaron BernieAaron Bernie More articles by this author , Yifeng PengYifeng Peng More articles by this author , Philip LiPhilip Li More articles by this author , Richard LeeRichard Lee More articles by this author , Chao JiaChao Jia More articles by this author , Benhai YangBenhai Yang More articles by this author , Quentin AworiQuentin Awori More articles by this author , Nian Qing LuNian Qing Lu More articles by this author , Mark BaroneMark Barone More articles by this author , and Marc GoldsteinMarc Goldstein More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.1349AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Numerous clinical and randomized controlled trials have confirmed that the Shang Ring is a safe, simple, and rapid method for performing adult and adolescent male circumcision. It has the potential to play an important role for reducing human immunodeficiency virus (HIV), human papillomavirus (HPV), and herpes simplex virus 2 (HSV-2) transmission in Africa. The advent of the no-flip Shang Ring circumcision procedure provides several advantages over the standard Shang Ring technique, such as eliminating the need to evert the foreskin over the inner ring and thus simplifying the overall technique. We now introduce the use of topical anesthesia will also eliminate the pain and morbidity associated with injectable anesthesia. METHODS No-flip Shang Ring circumcision was performed on 183 males (142 adults, 41 adolescents) with topical EMLA anesthesia. Topical anesthesia was applied inside and around the foreskin and with a dwell time of 25 to 30 minutes prior to circumcision. After circumcision, patients were asked to assess their pain both during the procedure as well as 24 hours after the procedure using the visual analog scale (VAS). RESULTS Mean no-flip Shang Ring circumcision procedural time was less than 4 minutes. Adolescents reported low pain scores during the Shang Ring circumcision with a mean VAS score of 2.3, despite 51% (n=21) of patients having a tight phimosis. 24 hour post-procedural pain remained low in these patients with a mean score of 2.7. Adult patients also reported low pain scores, with a mean VAS of 1.6 during circumcision and 2.2 24 hours post-procedure. CONCLUSIONS The no-flip Shang Ring circumcision can be successfully performed in a rapid fashion with topical EMLA anesthesia in adults and adolescents. Men undergoing this procedure experienced little pain during the procedure and minimal post-procedural pain. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e337 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Aaron Bernie More articles by this author Yifeng Peng More articles by this author Philip Li More articles by this author Richard Lee More articles by this author Chao Jia More articles by this author Benhai Yang More articles by this author Quentin Awori More articles by this author Nian Qing Lu More articles by this author Mark Barone More articles by this author Marc Goldstein More articles by this author Expand All Advertisement Advertisement PDF DownloadLoading ...

Clinical trials using the Shang Ring device for male circumcision in Africa: a review.

Male circumcision (MC) reduces the risk of HIV and other sexually transmitted infections (STIs), including human papillomavirus (HPV) and herpes simplex virus type 2 (HSV-2), and is recommended as an important component of a comprehensive package of HIV prevention interventions. While computer modeling has demonstrated that substantial reductions in HIV could be achieved with rapid scale-up of MC services in sub-Saharan Africa, scale-up has lagged due to scarcity of trained providers coupled with relative technical difficulty of recommended surgical MC techniques. Simplified techniques, such as devices, have the potential to allow for a more rapid roll-out of MC. One such device is the Shang Ring, a novel disposable MC device that eliminates the need for suturing and has been on the Chinese market since 2005. Results from Chinese studies have demonstrated that the Shang Ring is both safe and easy to use. Since 2008, a series of studies using the Shang Ring for adult MC have been carried out in Kenya, Uganda and Zambia, according to guidelines established by World Health Organization (WHO) for clinical evaluation of new devices for adult MC. These include a proof of concept study, a study of delayed removal of the Shang Ring, two studies comparing Shang Ring circumcision to conventional surgical approaches, and a large field trial to evaluate safety of Shang Ring circumcision during routine service delivery. Results from these studies demonstrate that the Shang Ring has an excellent safety profile and that Shang Ring circumcision is relatively easy to teach and learn, making Shang Ring MC an appealing technique for use in sub-Saharan Africa where doctors are in short supply and non-physician providers such as nurses and clinical officers are playing a major role in providing MC through task shifting. Shang Ring MC and device removals were uneventfully performed by trained nurses and clinical officers, who preferred the Shang Ring to conventional surgical techniques. Adverse event rates were similar to those observed with conventional surgical circumcision and were managed with, at most, minor interventions, resolving with no long-term sequale. Perhaps one of the biggest advantages of the Shang Ring is the relatively short 3-6 minutes procedure time. Importantly, men also preferred the Shang Ring compared to conventional circumcision and satisfaction with cosmetic appearance of their circumcised penis was very high. The vast majority of participants in studies in Africa as well as China have reported few problems and little disruption to daily life while wearing the device. The Shang Ring holds great promise as an innovative technology that has the potential to facilitate the safe and effective scale-up of circumcision services in settings where MC is not widely used and where the burden of HIV-disease is high.

Shang Ring Versus Forceps-Guided Adult Male Circumcision

Adult male circumcision (AMC) reduces HIV transmission, but uptake is limited in part by current surgical methods. We randomized HIV-uninfected men (n = 138) to receive Shang Ring (SR)- or forceps-guided AMC from a locally trained surgeon. In as-treated analyses, more SR procedures were completed within 10 minutes (79% versus 0%, P < 0.01) and more subjects reported high satisfaction (77% versus 58%, P = 0.03). Healing time and pain scores were similar, though minor complication rates were higher in SR subjects (56% versus 24%, P < 0.01). SR circumcision is a rapid and acceptable method of AMC and should be further evaluated to increase uptake of AMC.

Proper Surgical Training and Grading of Complications for Shang Ring Circumcision Are Necessary

Proper Surgical Training and Grading of Complications for Shang Ring Circumcision Are Necessary

A Randomized Clinical Study of Circumcision with a Ring Device Versus Conventional Circumcision

We investigated the safety and efficacy of Shang Ring™ male circumcision and conventional sleeve resection circumcision in a randomized study. During the same period, 479 cases of Shang Ring circumcision and 354 of sleeve resection circumcision were performed. Complete followup data were evaluated on the 2 groups. Operative time, pain score, blood loss, postoperative complications, wound healing time and treatment costs were compared. There was no statistically significant difference in average age and foreskin status between the 2 groups preoperatively (p >0.05). Compared to the conventional group, there were shorter operative time, less blood loss and a lower intraoperative pain score in the ring group (p <0.05). In addition, ring male circumcision showed a lower complication rate than conventional circumcision (6.89% vs 13.28%, p = 0.002). However, wound healing time in the ring group was longer than in the conventional group (mean ± SD 19.86 ± 5.24 vs 13.42 ± 2.35 days, p <0.001). Shang Ring male circumcision is a safe, efficient procedure with a relatively low complication rate and high patient satisfaction. It may be worthwhile to popularize this method, especially in countries where the general population has low to limited resources.

Randomized Trial of the Shang Ring for Adult Male Circumcision With Removal at One to Three Weeks

To assess healing with Shang Ring removal at different prespecified times; whether spontaneous detachment occurs with delayed removal; problems, complaints, and acceptability of wearing the device; satisfaction among participants; and acceptability of the procedure among providers. Fifty HIV-negative men underwent a Shang Ring circumcision in Kenya. Men were randomly assigned for device removal at 7 (15 men), 14 (15 men), or 21 days (20 men). Follow-up visits were at 7, 14, 21, 28, and 42 days after circumcision and 2 days after removal. Circumcision and device removal were conducted without significant problems. Mean times for circumcision and device removal were 6.5 (SD = 2.4) and 2.5 (SD = 0.8) minutes, respectively. Complete detachment of the device occurred in 22 (66.7%) men who wore it more than 7 days. Seven men (14.0%) with partial detachments requested removal 8-14 days postcircumcision due to pain/discomfort. Healing progressed normally in all participants; cumulative probabilities of complete healing were similar across groups. No severe or serious adverse events occurred. Acceptability among participants was high. Providers reported that Shang Ring circumcision was "very easy" compared with the forceps-guided procedure. The Shang Ring is safe and easy to use according to label instructions (7 day removal). Detachments occurred without significant problems, although some men requested removal of partially detached rings. Removal time had little effect on healing. These data help allay concerns about men not returning for ring removal and expand the evidence base suggesting the Shang Ring could facilitate rapid male circumcision rollout in sub-Saharan Africa.