Circumcision devices versus standard surgical techniques in adolescent and adult male circumcisions.

BACKGROUND: Medical circumcisions are among the most common surgical procedures performed in males. The usual indications are phimosis (inability to completely retract the foreskin and expose the glans due to a congenital or acquired constriction of the prepuce), paraphimosis (when the foreskin is not pulled back over the glans after retraction resulting in a tight constricting band which causes swelling of the distal penis and acute discomfort), balanoposthitis (erythema and edema of the prepuce and glans) and balanitis (inflammation is confined to the glans; the foreskin is usually non-retractile). Circumcision devices have been developed to shorten the operative time, simplify techniques, and improve safety and cosmetic outcomes. The devices generally aim to crush the foreskin while simultaneously creating hemostasis, the foreskin is then excised or allowed to slough off. Their use is supposedly safer and easier to replicate than the standard dissection techniques. There are at least 20 devices for male circumcision on the market, yet their effectiveness has not been reviewed to date. OBJECTIVES: To assess the effects of device-based circumcisions compared with standard surgical techniques in adolescent and adult males (10 years old and above). SEARCH METHODS: We performed a comprehensive search with no restrictions to the language of publication or publication status. We searched the Cochrane Library, MEDLINE (PubMed), Embase, Web of Science, trials registries, grey literature sources and conference proceedings up to 16 April 2020. SELECTION CRITERIA: We included randomized controlled trials of device-based circumcisions (crush or ligature circumcision devices) compared to standard surgical dissection-based circumcision conducted by health professionals in a medical setting. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed study eligibility and extracted data from the included studies. We classified adverse events into serious, moderate or mild. We reported study results as risk ratios (RR) or mean differences (MD) using 95% confidence intervals (CI) and a random-effects model. We used the GRADE approach to evaluate the overall certainty of the evidence for each outcome. MAIN RESULTS: Eighteen trials met the inclusion criteria. Trials were conducted in China, South Africa, Kenya and Zambia, Mozambique, Rwanda, Uganda and Zimbabwe. Primary outcomes Serious adverse events: there were no serious adverse events in either treatment arm (11 trials, 3472 participants). Moderate adverse events: there may be a slight increase in moderate adverse events when devices are used compared to standard surgical techniques (RR 1.31, 95% CI 0.55 to 3.10; I²= 68%; 10 trials, 3370 participants; low-certainty evidence); this corresponds to 8 more (ranging from 15 fewer to 84 more) moderate adverse events per 1000 participants. We downgraded the certainty of the evidence for study limitations and imprecision. Secondary outcomes Mild adverse events: we are uncertain about the difference in mild adverse events between groups when devices are used compared to standard surgical techniques (RR 1.09, 95% CI 0.44 to 2.72; I² = 91%; 10 trials, 3370 participants; very low-certainty evidence). We downgraded the certainty of the evidence for study limitations, imprecision and unexplained inconsistency. Operative time: operative time is probably about 17 minutes shorter when using a device rather than standard surgical techniques, which constitutes a clinically meaningful decrease in a procedure (MD -17.26 minutes, 95% CI -19.96 to -14.57; I² = 99%; 14 trials, 4812 participants; moderate-certainty evidence). We downgraded the certainty of the evidence for serious study limitations. The standard surgical technique generally takes about 24 minutes. There may be less postoperative pain during the first 24 hours when circumcision devices are used compared to standard surgical techniques (measured using a visual analog scale [VAS]; MD 1.30 cm lower, 95% CI 2.37 lower to 0.22 lower; I² = 99%; 9 trials, 3022 participants; low-certainty evidence). We downgraded the certainty of the evidence for study limitations and unexplained heterogeneity. There may be little or no difference in postoperative pain experienced during the first seven days when compared with standard surgical techniques (measured using a VAS; MD 0.11 cm higher, 95% CI 0.89 lower to 1.11 higher; I² = 94%; 4 trials, 1430 participants; low-certainty evidence). We downgraded the certainty of the evidence for study limitations and unexplained inconsistency. A higher score on the VAS indicates greater pain. Participants may slightly prefer circumcision devices compared to standard surgical techniques (RR 1.19, 95% CI 1.04 to 1.37; I² = 97%; 15 trials, 4501 participants; low-certainty evidence). We downgraded the certainty of the evidence for study limitations and unexplained inconsistency. We recorded satisfaction as a dichotomous outcome. Higher rates reflected greater satisfaction. AUTHORS' CONCLUSIONS: We found that there were no serious adverse events reported when using a circumcision device compared to standard surgical techniques, but they may slightly increase moderate adverse effects, and it is unclear whether there is a difference in mild adverse effects. Use of circumcision devices probably reduces the time of the procedure by about 17 minutes, a clinically meaningful time saving. For patients, use of the circumcision device may result in lower pain scores during the first 24 hours and patients may be slightly more satisfied with it compared with standard surgical techniques. Clinicians, patients and policymakers can use these results in conjunction with their own contextual factors to inform the approach that best suits their healthcare settings. High-quality trials evaluating this intervention are needed to provide further certainty regarding the rates of adverse effects and postoperative pain of using devices compared to standard approaches.

Postoperative aesthetic and healing features of postectomy using three different surgical techniques: a randomized, prospective, and interdisciplinary analysis.

OBJECTIVE: to compare the postoperative esthetic and healing aspects of postectomy performed by different surgical techniques, based on the evaluation of different specialty expert professionals. METHODS: prospective and randomized clinical trial enrolling 149 preschool children with a medical indication for circumcision, divided into three groups: postectomy with the hemostatic device Plastibell® (PB group), conventional technique (CV group) and conventional with subcuticular stitches (SC group). Pictures were taken from patients at pre-defined angles on the 30th and 60th postoperative days. Photos were evaluated by three specialists (dermatologist, pediatrician and plastic surgeon), who assigned scores from 1 to 5 regarding the esthetic and healing features at each moment. Grades 4 or 5 from all specialists characterized "best result". Data were analysed to compare the used surgical techniques, the judgments from specialties and postoperative complications. RESULTS: most of the patients obtained the "best result" regarding healing (70%) and esthetics (56%). The final overall result showed the PB group as the best for healing (p=0.028) and the SC group as the best for esthetics (p=0.002). For the dermatologist, on the 60th postoperative day, the CV group presented the worst aesthetic result, whereas for the pediatrician and the plastic surgeon, the PB group presented the best healing result and the SC group had the best esthetic result. There was no difference between the groups regarding the presence of complications. CONCLUSION: the most common surgical techniques used to perform postectomy in children were differently assessed regarding healing and esthetic features by distinct medical professionals. The analysis of these two parameters among experts from related areas diverged among them and over time.

Modified Circumcision Using the Disposable Circumcision Suture Device in Children: A Randomized Controlled Trial.

OBJECTIVE: To evaluate and compare the surgical outcomes and complications of the modified circumcision using disposable circumcision suture device (device group) and the conventional dorsal slit circumcision (conventional group) in children. METHODS: A total of 284 patients were randomized to either device group or conventional group. All patients were preoperatively assessed and evaluated at 4 weeks after surgery. The perioperative data and postoperative outcomes were compared between the 2 groups. RESULTS: No statistical differences were observed in the average age and indications between the 2 groups preoperatively (P > .05). Compared with the conventional group, patients in the device group were shorter mean operative time, less blood loss, lower intraoperative and postoperative pain score, faster incision healing time and a higher satisfaction rate of penile cosmetic appearance (P < .01). Similarly, the incidences of complication were significantly lower in the device group than in the conventional group (4.3% vs 12.3%, P < .05). CONCLUSIONS: The modified circumcision using disposable circumcision suture device is a simple, safe, faster, and effective procedure and may become the attractive alternative to the conventional technique for the children, with a relatively lower complication rate and better cosmetic results. With the improvement of disposable circumcision suture device, the modified circumcision using disposable circumcision suture device has the potential to be widely used in the world.

Newborn Circumcision Techniques.

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.

Preputial circumcision performed with a new mechanical stapling tool. The "langhe disposable circumcision suture device". Preliminary experiences.

The Authors present their preliminary clinical experiences in performing preputial circumcision utilizing a new stapling tool.

Postoperative aesthetic and healing features of postectomy using three different surgical techniques: a randomized, prospective, and interdisciplinary analysis / Aspectos estético e cicatricial pós-operatórios da postectomia por três diferentes técnicas cirúrgicas: análise randomizada, prospectiva e interdisciplinar

ABSTRACT Objective: to compare the postoperative esthetic and healing aspects of postectomy performed by different surgical techniques, based on the evaluation of different specialty expert professionals. Methods: prospective and randomized clinical trial enrolling 149 preschool children with a medical indication for circumcision, divided into three groups: postectomy with the hemostatic device Plastibell® (PB group), conventional technique (CV group) and conventional with subcuticular stitches (SC group). Pictures were taken from patients at pre-defined angles on the 30th and 60th postoperative days. Photos were evaluated by three specialists (dermatologist, pediatrician and plastic surgeon), who assigned scores from 1 to 5 regarding the esthetic and healing features at each moment. Grades 4 or 5 from all specialists characterized "best result". Data were analysed to compare the used surgical techniques, the judgments from specialties and postoperative complications. Results: most of the patients obtained the "best result" regarding healing (70%) and esthetics (56%). The final overall result showed the PB group as the best for healing (p=0.028) and the SC group as the best for esthetics (p=0.002). For the dermatologist, on the 60th postoperative day, the CV group presented the worst aesthetic result, whereas for the pediatrician and the plastic surgeon, the PB group presented the best healing result and the SC group had the best esthetic result. There was no difference between the groups regarding the presence of complications. Conclusion: the most common surgical techniques used to perform postectomy in children were differently assessed regarding healing and esthetic features by distinct medical professionals. The analysis of these two parameters among experts from related areas diverged among them and over time.

RESUMO Objetivo: analisar os aspectos estético e cicatricial pós-operatórios (PO) de pacientes submetidos a postectomia por diferentes técnicas cirúrgicas a partir da avaliação de profissionais experientes de áreas afins. Método: ensaio clínico prospectivo e randomizado, incluindo 149 meninos em idade pré-escolar com indicação médica de postectomia, divididos em três grupos: postectomia com dispositivo hemostático Plastibell® (grupo PB), técnica convencional (grupo CV) e convencional com pontos subcuticulares (grupo SC). Os pacientes foram fotografados em ângulos predefinidos no 30º e 60º dias de PO e as fotos avaliadas por três especialistas (dermatologista, pediatra e cirurgião plástico) que atribuíram notas entre 1 e 5, quanto aos aspectos estético e cicatricial em cada momento. Notas 4 ou 5 de todos os especialistas caracterizaram o "melhor resultado". Os dados foram submetidos à análise estatística para comparar as técnicas cirúrgicas, as avaliações dos especialistas e as complicações pós-operatórias. Resultados: a maioria dos pacientes obteve "melhor resultado" cicatricial (70%) e estético (56%). O resultado geral final apontou o grupo PB como superior quanto à cicatrização (p=0,028) e o grupo SC quanto ao aspecto estético (p=0,002). Para o dermatologista, na segunda avaliação, o grupo CV apresentou o pior resultado estético, enquanto para o pediatra e o cirurgião plástico, o grupo PB apresentou o melhor resultado cicatricial e o grupo SC o melhor resultado estético. Não houve diferença entre os grupos quanto à presença de complicações. Conclusão: as técnicas cirúrgicas mais empregadas para realizar postectomia em crianças foram avaliadas quanto aos resultados cicatricial e estético de distintas maneiras. A análise desses dois parâmetros entre especialistas de áreas afins divergiu entre eles e ao longo do tempo.

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

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.

Neonatal plastibell circumcision: does the thread type matter? a prospective randomized study.

INTRODUCTION: Plastibell is one of the most common disposable devices used for circumcision. The study aims to determine whether changing the thread type from cotton to polypropylene to tie around the Plastibell in neonatal circumcision would result in faster separation of the ring. PATIENTS AND METHODS: Prospective, randomized, clinical and biomechanical studies were performed. All circumcisions were performed by a single surgeon. Data collected included anthropometric measures, demographic data, procedure time, complications, parent satisfaction, follow-up, and outcomes. The biomechanical study measured the tensile properties of both threads using a universal testing machine (4465; Instron, Norwood, MA). RESULTS: Two hundred full-term, male neonates aged between 24 and 48 h were circumcised using Plastibell. Both groups were similar in gestational age, age at circumcision, body weight, height, head circumference, Apgar score at 1 and 5 min, procedure time, Plastibell size, and parent satisfaction. The subjects were randomized into two groups of 100 neonates each: group I where Plastibell was tied by a cotton thread supplied by the manufacturer and group II where Plastibell was tied by Polypropylene 0. The mean duration for Plastibell fall-off was 8.98 days and 7.74 days in cotton thread and Polypropylene 0, respectively (P-value < 0.001). There was no difference regarding the complications for both groups. The diameters of the cotton and Polypropylene 0 threads were 0.68 mm and 0.35 mm, respectively. The measured tensile strengths of cotton and Polypropylene thread were 180 MPa and 457 MPa, respectively. CONCLUSION: Plastibell tied by Polypropylene 0 fell off faster than that tied by cotton thread, with no significant differences in adverse effects or complications. This finding might be relevant for anxious parents and caregivers. Further studies are needed to examine other types and sizes of threads to investigate whether this separation period can be reduced further.

Glandular amputation by strangulating tied suture: a case report of late-onset complication in the Plastibell circumcision technique.

BACKGROUND: Circumcision is considered to be a procedure with minimal morbidity but may be associated with catastrophic complications in inexpert hands. CASE PRESENTATION: We presented a 9-year-old boy with a past medical history of circumcision at the age of one year with Plastibell clamp who was referred with severe chronic penile injury due to neglected plastibell string. After string removal under a loupe magnification (4×), we saw a deep circular injury at distal penile shaft which led to painless glandular autoamputation 45 days later. The patient was managed conservatively with daily urethral self-dilation until future reconstructive surgery. CONCLUSION: This complication emphasized the importance of the follow-up visit by a physician for any probable string remnant.

Is the PrePex device an alternative for surgical male circumcision in adolescents ages 13-17 years? Findings from routine service delivery during active surveillance in Zimbabwe.

BACKGROUND: Male circumcision devices have the potential to accelerate adolescent voluntary medical male circumcision roll-out. Here, we present findings on safety, acceptability and satisfaction from active surveillance of PrePex implementation among 618 adolescent males (13-17 years) circumcised in Zimbabwe. METHODS: The first 618 adolescents consecutively circumcised from October 2015 to October 2016 using PrePex during routine service delivery were actively followed up. Outcome measures included PrePex uptake, attendance for post-circumcision visits and adverse events (AEs). A survey was conducted amongst 500 consecutive active surveillance clients to assess acceptability and satisfaction with PrePex. RESULTS: A total of 1,811 adolescent males were circumcised across the three PrePex active surveillance sites. Of these, 870 (48%) opted for PrePex but only 618/870 (71%) were eligible. Among the 618, two (0.3%) self-removals requiring surgery (severe AEs), were observed. Four (0.6%) removals by providers (moderate AEs) did not require surgery. Another 6 (1%) mild AEs were due to: bleeding (n = 2), swelling (n = 2), and infection (n = 2). All AEs resolved without sequelae. Adherence to follow-up appointments was high (97.7% attended 7 day visit). A high proportion (71.6%) of survey respondents said they heard about PrePex from a mobilizer; 49.8% said they chose PrePex because they wanted to avoid the pain associated with the surgical procedure/surgery on their penis. Acceptability and satisfaction with PrePex was high; 95.4% indicated willingness to recommend PrePex to peers. A majority (92%) reported experiencing pain when PrePex was being removed. CONCLUSIONS: Active surveillance of the first 618 adolescent males circumcised using PrePex suggests that the device is both safe and acceptable when used in routine service delivery among 13-17 year-olds. There is need to intensify specific demand generation activities for PrePex male circumcision among this group of males.

Avoidance of general anesthesia for circumcision in infants under 6 months of age using a modified Plastibell technique.

PURPOSE: There is currently no gold standard for the type of analgesia or preferred circumcision technique in infants requiring circumcision after 1 month of age. Our study presents a modified Plastibell circumcision technique, which offers excellent surgical outcomes, and can be performed under local anesthesia until 6 months of age, thereby avoiding the risks of general anesthesia in delayed circumcision. METHODS: This is a retrospective case series of 508 consecutive male infants between 1 and 6 months of age, from one institution, who all underwent circumcision under local anesthesia, performed by the same pediatric surgeon, from 2013 to 2018. The study parameters included postoperative complications such as re-operation for control of hemorrhage, wound infection, circumcision revision, and urethral meatotomy. RESULTS: There were no re-operations for control of hemorrhage, no wound infections, and no circumcision revisions. One patient developed urethral meatal stenosis requiring urethral meatotomy. CONCLUSION: Our modified Plastibell circumcision technique under local anesthesia is a safe and reproducible alternative for infants between 1 and 6 months of age, whose parents desire circumcision and wish to avoid general anesthesia.

Timing of adverse events among voluntary medical male circumcision clients: Implications from routine service delivery in Zimbabwe.

BACKGROUND: Timing of routine follow-up visits after adult male circumcision (MC) differs by country and method. Most men do not attend all routine follow-up visits. This cross-sectional study aimed to further understanding of AE timing within a large-scale, routine, MC program to improve patient safety. METHODS: From 2013-2017, ZAZIC consortium performed 192,575 MCs in Zimbabwe; the reported adverse event (AE) rate was 0.3%. Three scheduled, routine, follow-up visits intend to identify AEs. For surgical MC, visits were days 2, 7 and 42 post-procedure. For PrePex (device-based), visits were days 7, 14 and 49. Descriptive statistics explored characteristics of those patients with AEs. For each MC method, chi-square tests were used to evaluate associations between AE timing (days from MC to AE diagnosis) and factors of interest (age, AE type, severity). RESULTS: Of 421 AEs, 290 (69%) were surgical clients: 55 (19%) AEs were ≤2 days post-MC; 169 (58%) between 3-7 days; 47 (16%) between days 8-14; and 19 (7%) were ≥15 post-MC. Among surgical clients, bleeding was most common AE on/before Day 2 while infections predominated in other follow-up periods (p<0.001). Younger surgical MC patients with AEs experienced AEs later than older clients (p<0.001). Among 131 (31%) PrePex clients with AEs, 46 (35%) were ≤2 days post-MC; 59 (45%) between 3-7 days; 16 (12%) between days 8-14; and 10 (7%) ≥15 post-MC. For PrePex clients, device displacements were more likely to occur early while late AEs were most commonly infections (p<0.001). CONCLUSION: Almost 23% of surgical and 8% of PrePex AEs occurred after Visit 2. Later AEs were likely infections. Clinicians, clients, and caregivers should be more effectively counseled that complications may arise after initial visits. Messages emphasizing attention to wound care until complete healing could help ensure client safety. Younger boys, ages 10-14, and their caregivers would benefit from improved, targeted, post-operative counseling.

[Surgical plane positioning with a disposable circumcision suture device for the treatment of phimosis and redundant prepuce].

OBJECTIVE: To investigate the clinical effects of circumcision by surgical plane positioning with a disposable circumcision suture device in the treatment of phimosis and redundant prepuce. METHODS: From September 2016 to June 2017, we treated 250 patients with phimosis or redundant prepuce, 127 by conventional circumcision (the control group) and the other 123 by surgical plane positioning with a disposable circumcision suture device (the observation group). We compared the operation time, intra-operative bleeding, preputial frenulum alignment, postoperative ecchymosis, and postoperative penile appearance between the two groups of patients. RESULTS: Compared with the controls, the patients in the observation group showed significantly longer operation time (ï¼»4.48 ± 1.18ï¼½ vs ï¼»7.17 ± 1.42ï¼½ min, P<0.05), lower rates of intra-operative frenulum bleeding (15.0% ï¼»19/127ï¼½ vs 4.1% ï¼»5/123ï¼½, P<0.05) and frenulum misalignment (26.8% ï¼»34/127ï¼½ vs 0.8% ï¼»1/123ï¼½, P<0.05), higher incidence of postoperative ecchymosis (41.7% ï¼»53/127ï¼½ vs 21.1% ï¼»26/123ï¼½, P<0.05), and higher satisfaction of the patients with the postoperative penile appearance (92.9% ï¼»18/127ï¼½ vs 98.4% ï¼»121/123ï¼½, P<0.05). However, no statistically significant difference was found between the control and observation groups in intra-operative non-frenulum bleeding (4.7% ï¼»6/127ï¼½ vs 1.6% ï¼»2/123ï¼½, P = 0.164). CONCLUSIONS: Circumcision by surgical plane positioning with a disposable circumcision suture device can effectively avoid preputial frenulum misalignment, reduce intra-operative bleeding, and improve postoperative penile appearance.

Circumcision: postoperative complications that required reoperation.

Objective To evaluate post-operative complications of circumcision requiring surgical reintervention. Methods Retrospective analysis of medical records of patients submitted to circumcision from May 1st, 2015 to May 31st, 2016. Results A total of 2,441 circumcisions were performed; in that, 1,940 using Plastibell and 501 by the classic technique. Complications requiring surgical reintervention were found in 3.27% of patients. When separated by surgical technique, 3.4% of circumcisions using Plastibell device required reoperation, as compared to 3% of conventional technique (p=0.79). Preputial stenosis was most frequently found in classic circumcision, with statistical significance (p<0.001). Bleeding was more frequent when using Plastibell device, but the difference was not statistically different (p=0.37). Patients' age was also evaluated to investigate if this variable influenced on the postoperative outcome, but no significant difference was found. Conclusion There was no statistically significant difference when comparing complications between the different techniques performed at this hospital. Preputial stenosis was most frequently found in the classic circumcision, while bleeding was more prevalent when using Plastibell device. Patients' age did not influence in complications.

Novel Devices for Adolescent and Adult Male Circumcision.

There is an abundance of devices for adolescent and adult male circumcision (MC). It has been shown that the safety and efficacy of device-assisted MC are equal to or better than those for MC via conventional surgery. MC devices have the potential to simplify the procedure and increase the acceptability of circumcision among patients.

PrePex circumcision surveillance: Adverse events and analgesia for device removal.

BACKGROUND: The PrePex medical male circumcision (MMC) device is relatively easy to place and remove with some training. PrePex has been evaluated in several countries to assess feasibility and acceptability. However, several studies have reported pain associated with removal. OBJECTIVE: To assess safety of PrePex and whether analgesia administered prior to removal reduces pain experienced by participants. METHODS: A multi-site non-randomized, prospective cohort study in which adult (18-45 years old) males requesting PrePex device male circumcision, were enrolled in six South African clinics from July 2014 to March 2015. Participants were routinely provided with analgesia shortly after the surveillance commenced following a protocol review. Analgesia regimen for device removal depended on medication availability at clinics. RESULTS: Of 1023 enrolled participants who had PrePex placed, 98% (1004) had the device removed at a study clinic. Their median age was 25 (IQR: 21-30) years. HIV sero-positivity was 3.6% (37/1023). Nurses placed and removed half of all devices. Adverse events were experienced by 2.4% (25/1023) of participants; 15 required surgical intervention: device displacement (5/14), early removals (3/14), self-removals (5/14) and insufficient skin removed (2/14). Majority (792: 79%) of participants received analgesia. Most received either paracetamol-codeine (33%), lidocaine (29%) or EMLA and Oral Combination (28%). A lower proportion of participants who received any analgesia (except for lidocaine) prior to PrePex removal experienced severe pain compared to those who received no analgesia (16.6% vs. 29%: p = 0.0001). CONCLUSION: Reported adverse events during this PrePex active surveillance were similar to previous reports and to those of surgical circumcision. Pain medication provided prior to removal is effective at decreasing severe pain during PrePex device removal.

Field evaluation of the safety, acceptability, and feasibility of early infant male circumcision using the AccuCirc device.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Choosing the appropriate ShangRing size for paediatric circumcision using the no-flip technique.

AIM: To determine the correct ShangRing size for paediatric circumcision using the no-flip technique. METHODS: A cohort of 104 boys (from 6 to 14 years) underwent ShangRing circumcision at Ningbo First Hospital, China. The patients were randomly divided into three groups according to the different methods used for choosing the ring size. For Group A, the ring size was chosen using the ShangRing measuring tape; for Group B, ring size was chosen based on the diameter of penis measured using a self-designed scale plate; and for Group C, ring size was chosen based on the diameter of the glans measured using the self-designed scale plate. The surgery duration, foreskin dorsal slit rate, intra-operative and post-surgery pain score, pain duration, post-surgery ring detachment duration, pain score for ring detachment, complication rate and satisfaction rate were compared. RESULTS: Group A had the highest dorsal slit rate and the longest surgical period. There were no significant differences in intra-/post-surgery pain or ring detachment duration among the three groups. The post-surgery oedema rate and foreskin asymmetry occurrence rate was the highest in Group A at 40.62 and 21.88%, respectively. Group C had the highest satisfaction rate (97.14%), with a significant difference from Group A (75.00%). Oedema and asymmetry of the foreskin increased, while the satisfaction rate simultaneously decreased when a larger ShangRing was chosen. CONCLUSIONS: The size of the ShangRing should be chosen in accordance with the diameter of the glans in paediatric ShangRing circumcision using the no-flip technique.