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IntroductionMale circumcision (MC) has been shown to decrease transmission of HIV and is a critical strategy to decrease its incidence in countries with high rates of heterosexually transmitted HIV. Early infant MC (EIMC), with single-use MC devices, could increase rates of MC in Sub-Saharan Africa. Our objective was to determine the safety, efficacy and satisfaction of ShangRing EIMC in resource-constrained environments.MethodsHealthy male infants aged 1–60 days underwent ShangRing EIMC performed by non-physician clinicians in 14 sites in Kenya, Tanzania and Uganda. The primary outcomes were the safety and efficacy of ShangRing EIMC. Secondary outcomes were pain related to the procedure, wound healing and parental satisfaction. Male infants were assessed at discharge and on postoperative days 7 and 28 for wound healing and complications. This trial is registered with Clinical.Trials.gov, NCT03338699, and is complete.ResultsFrom the 1697 participants enrolled from February to November 2020, 1691 (99.6%) underwent ShangRing EIMC. Median duration of the procedure was 10 min (IQR 6–13). The mean Neonatal Infant Pain Scale 20 min postprocedure was 0.3 (SD 0.8), indicating no pain. At the time of discharge, 1679 (99.0%) participants had a normal-appearing wound and 1574 (93.1%) demonstrated complete wound healing at 28 days. A total of 17 (1.0%) AEs were reported, most related to bleeding. A total of 1635 (99.1%) of parents were satisfied with the appearance of the circumcised penis at 28 days.ConclusionShangRing EIMC is a simple and successful MC method that non-physician clinicians can perform safely, with low AE rate, satisfactory wound healing and high satisfaction rate among parents. This indicates that the ShangRing EIMC can be considered a long-term strategic approach to accelerate the scale-up of MC in Sub-Saharan Africa.Trial registration numberNCT03338699.

In our experience patients undergoing circumcision are mostly concerned about pain and penile appearances. We conducted a prospective randomized trial to assess the benefits of a new disposable circumcision suture device （DCSD）. A total of 942 patients were equally divided into three groups （conventional circumcision, Shang ring and disposable suture device group）. Patients in the DCSD group were anesthetized with compound 5% lidocaine cream, the others with a 2% lidocaine penile block. Operation time, intra-operative blood loss, incision healing time, intra-operative and post-operative pain, the penile appearance and overall satisfaction degree were measured. Operation time and intra-operative blood loss were significantly lower in the Shang ring and suture device groups compared to the conventional group （P 〈 0.001）. Intra-operative pain was less in the suture device group compared With the other two groups （P 〈 0.001）; whereas post-operative pain was higher in the conventional group compared to the other two groups （P 〈 0.001）. Patients in the suture device （80.57%） and Shang ring （73,57%） groups were more satisfied with penile appearances compared with the conventional circumcision group （20.06%, P 〈 0.05）. Patients in suture device group also healed markedly faster than the conventional group （P 〈 0.01）. The overall satisfaction rate was better in the suture device group （78.66%） compared with the conventional （47.13%） and Shang ring （50.00%） groups （P 〈 0.05）. The combination of DCSD and lidocaine cream resulted in shorter operation and incision healing times, reduced intra-operative and post-operative pain and improved patient satisfaction with the cosmetic appearances.

The World Health Organization (WHO) and the Joint United Nations Program on HIV/AIDS promote MC (male circumcision) as a key HIV prevention strategy where HIV prevalence and incidence are high and MC prevalence is low. In Zimbabwe, to achieve the 1.26 million circumcisions needed to be performed by 2015 to achieve optimal MC coverage, a new approach was needed. The primary objective of the current trial was to assess the performance (safety, procedure time, and cost) of the PrePex device compared to forceps-guided surgical circumcision. This Phase II, randomized, open-label trial in Zimbabwe involved healthy, non-circumcised adult male volunteers who were randomly assigned to the PrePex device (n = 160) or surgical arm (n = 80). Three doctors and 4 nurses, all certified on both circumcision methods, performed the procedures. The PrePex device procedure involves a plastic ring with a rubber O-ring that necrotizes the foreskin to facilitate easy and minimally invasive removal. Total procedure time was the primary endpoint. Adverse event (AE) data were also gathered for 90 days post-procedure. All 80 participants in the surgical arm and 158 participants in the PrePex arm achieved complete circumcision. The total procedure time for the PrePex device was approximately one-third of the total surgical procedure (4.8 minutes, Standard Deviation [SD]: 1.2 versus 14.6 minutes; SD: 4.2; p<0.00001). There were 2 AEs for 2 participants (rate of 1.3%, 95% Confidence Interval: 0.0025-4.53%), which were resolved with simple intervention. The AEs were device related, including 1 case of pain leading to device removal and 1 case of removal of the device. The trial supports previous studies' conclusions that the PrePex procedure is safe, quick, easy to apply, and effective in terms of procedure time as an alternative to traditional surgical circumcision. The PrePex device has great potential for use in overburdened health systems and in resource-limited settings and is recommended for use in rapid scale-up of adult MC in Zimbabwe. ClinicalTrials.gov NCT01956370.

This paper was aimed to compare the clinical effectiveness and safety of adult male circumcision using the Shang RingTM （SR） with the no-flip technique compared with Dorsal Slit （DS） surgical method, A single-centered, prospective study was conducted at the West China Hospital, where patients were circumcised using the no-flip SR （n = 408） or the DS （n = 94） procedure. The adverse events （AEs） and satisfaction were recorded for both groups, and ring-removal time and percentage of delayed removals were recorded for the SR group. Finally, complete follow-up data were collected for 76.1% of patients （SR： n = 306; DS： n = 76）. The average ring-removal time for the SR group was 17.62 ± 6.30 days. The operation time （P 〈 0.001）, pain scores during the procedure （P 〈 0.001） and at 24 h postoperatively （P 〈 0.001）, bleeding （P = 0.001）, infection （P = 0.034）, and satisfaction with penile appearance （P 〈 0.001） in the SR group were superior to those in the DS group. After two postoperative weeks, the percentage of patients with edema in the SR group （P = 0.029） was higher but no differences were found at 4 weeks （P = 0, 185） between the two groups. In conclusions, the no-flip SR method was found to be superior to the DS method for its short operation time （〈5 min）, involving less pain, bleeding, infection, and resulting in a satisfactory appearance. However, the time for recovery from edema took longer, and patients may wear device for 2-3 weeks after the procedure.

The PrePex is a WHO--prequalified medical device for adult male circumcision for HIV prevention. The Government of Rwanda was the first country to implement the PrePex device and acts as the leading center of excellence providing training and formal guidelines. As part of the Government's efforts to improve PrePex implementation, it made efforts to improve the psychological acceptability of device by men, thus increasing uptake with VMMC in sub-Saharan Africa. Some men who underwent the PrePex procedure complained of foreskin odor while wearing the PrePex 3-7 days after it was placed. This complaint was identified as potential risk for uptake of the device. Researchers from Rwanda assumed there is a possible relation between the level of foreskin odor and patient foreskin hygiene technique. The Government of Rwanda decided to investigate those assumptions in a scientific way and conduct a trial to test different hygiene-cleaning methods in order to increase the acceptability of PrePex and mitigate the odor concern. The main objective of the trial was to compare odor levels between three arms, having identical personal hygiene but different foreskin hygiene techniques using either clear water with soap during a daily shower, soapy water using a syringe, or chlorhexidine using a syringe. One hundred and one subjects were enrolled to the trial and randomly allocated into three trial arms. Using chlorhexidine solution daily almost completely eliminated odor, and was statistically significant more effective that the other two arms. The trial results suggest that odor from the foreskin, while wearing the PrePex device, could be related to the growth of anaerobic bacteria, which can be prevented by a chlorhexidine cleaning method. This finding can be used to increase acceptability by men when considering PrePex as one of the leading methods for HIV prevention in VMMC programs.

In this study from Rwanda, voluntary adult male circumcision costs 33% less with trained nurses using the PrePex device compared with physician-nurse teams performing dorsal-slit surgery. These cost savings and the documented safety, speed, and efficacy of the PrePex procedure, serve Rwanda's HIV prevention program.

Voluntary medical male circumcision (VMMC) is a priority human immunodeficiency virus (HIV) preventive intervention. Challenges in funding national VMMC programmes mandate us to adopt new methods to provide circumcisions in a primary care setting. This study aims to test the practicality of instrument-assisted circumcision in primary care in pre-school-age boys. The study setting was one primary care centre in Western Cape, South Africa. The methodology adopted is prospective case series of minimally invasive voluntary circumcision using the Unicirc instrument in boys less than 6 years of age. We circumcised 221 healthy boys using the Unicirc instrument, using a combination of topical anaesthetic, subcutaneous local anaesthetic and intramuscular ketamine. There were 5 (2.3%) mild complications and 48 (21.7%) had mucosal swelling as a result of lysis of physiological phimosis. All boys were fully healed at 2 weeks and all caregivers were highly satisfied. Using a circumcision instrument in primary care simplifies circumcision in pre-school-age boys and has a low rate of adverse events. This study demonstrates that a new model of circumcision in primary care may enhance national VMMC programmes.

Newborn male circumcision is a common elective surgical procedure for the removal of foreskin covering the glans penis. The American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the Centers for Disease Control and Prevention, and the American Academy of Family Physicians recognize that there are health benefits of newborn male circumcision but do not universally recommend the procedure. Performing male circumcision during the neonatal period has several advantages, including a lower risk of complications, faster healing, and lower cost. The three most common techniques for newborn male circumcision utilize the Mogen clamp, the Gomco clamp, or the Plastibell device. Complications are uncommon and can include bleeding, injury to the penis, adhesions, excessive skin removal, phimosis, and meatal stenosis. Anatomic and medical contraindications may require that the procedure be deferred beyond the neonatal period. Infants with anatomic abnormalities should be referred to a pediatric urologist. Physicians should present information about potential benefits and risks rather than withholding or recommending circumcision. Parents should weigh the health benefits and risks and consider their own religious, cultural, and personal preferences when making the decision.

Purpose Circumcision is the most common surgical procedures performed in males. Medical circumcision is recommended for diseases such as phimosis, paraphimosis, balanoposthitis and common urinary tract infections, although there is no exact indication. Conversely, Jewish and Muslim individuals commonly undergo circumcision regardless of medical necessity. Circumcision devices are designed to shorten surgery time, achieve an aesthetic appearance and ensure safe surgery. The aim of this study is to evaluate the effectiveness of the NeoAlis clamp, a disposable circumcision device, by comparing it with the sleeve technique in children. Materials and methods Between 2017 and 2023, retrospective evaluation of 2626 patients who underwent circumcision using either the NeoAlis clamp (group 1) or the sleeve technique (group 2) was conducted. Operation time, results, cost, complications were compared between the two groups. Results The study encompassed 2626 patients who fulfilled the inclusion criteria. Group 1 comprised 2403 patients, whereas Group 2 consisted of 223 patients. The overall complication rate, as denoted by n  = 47, was 1.7%. Group 1 operation time was shorter than group 2. Bleeding, the most feared complication in the early period, was higher in the second group. No statistically significant difference was observed between the two groups regarding cost comparison. Conclusion The primary concern during circumcision is to avoid complications related to general anesthesia in newborns and infants. The use of disposable ring devices has been facilitated by the shorter operation time and the absence of the need for sutures when performing circumcision under local anesthesia. However, knowledge of advanced surgical circumcision techniques is necessary in cases of bleeding and inappropriate ring placement.

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.