Randomised trial of early infant circumcision performed by clinical officers and registered nurse midwives using the Mogen clamp in Rakai, Uganda

Kankaka, Edward Nelson; Murungi, Teddy; Kigozi, Godfrey; Makumbi, Frederick; Nabukalu, Dorean; Watya, Stephen; Kighoma, Nehemiah; Resty, Nampijja; Kayiwa, Daniel; Nalugoda, Fred; Serwadda, David; Wawer, Maria J.; Gray, Ronald H.

doi:10.1111/bju.13589

Cited by 12 publications

(15 citation statements)

References 13 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The authors expressed preference for the Mogen clamp due to the risk of migration and retention of the Plastibell, which could result in necrosis of the glans in the absence of the kind of follow-up inherent to a research study [ 25 ]. The Mogen is the device currently approved by the Kenya Ministry of Health for EIMC [ 8 ], and several studies and demonstration projects have chosen to employ the Mogen clamp [ 12 – 14 , 17 , 18 ], including two studies conducted by our group [ 12 , 19 , 26 , 27 ]. Adverse event rates when employing the Mogen are relatively low.…”

Section: Discussionmentioning

confidence: 99%

“…In 2010, the WHO published the “Manual for Early Infant Male Circumcision under Local Anaesthesia [ 11 ],” which included pre-qualification of the Mogen, Gomco and Plastibell devices for EIMC. Since that time, several studies and demonstration projects have employed the Mogen clamp [ 9 , 10 , 12 – 14 ], and the Mogen is the device currently approved by the Kenyan Ministry of Health for EIMC [ 15 ]. However, other devices are being field tested and are under consideration for adoption in several African countries.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

What device would be best for early infant male circumcision in east and southern Africa? Provider experiences and opinions with three different devices in Kenya

2017

View full text Add to dashboard Cite

Voluntary medical male circumcision (VMMC) reduces risk of HIV acquisition in heterosexual men by approximately 60%. As some countries approach targets for proportions of adolescents and adults circumcised, some are considering early infant male circumcision (EIMC) as a means to achieve sustainability of VMMC for long term reduction of HIV incidence. Evaluations of specialized devices for EIMC are important to provide programs with information required to make informed decisions about how to design safe, effective EIMC programs. We provide assessments by 11 providers with experience in Kenya employing all three of the devices most likely to be considered by various EIMC programs in east and Southern Africa. There was no one device that was seen to be clearly superior to the others. Each had its own advantages and disadvantages. Provider preferences were situation-specific. Most preferred the Mogen Clamp if they themselves were performing the procedure. However, most were concerned that not everyone will have the skills necessary for optimal safety. If someone else were circumcising their son, most would opt for the AccuCirc because of the risk of severing the glans when using the Mogen. A minority preferred the PrePex, but only if the baby received local anesthesia, not EMLA cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%), as presently prescribed by the manufacturer. In the context of a national EIMC program, all participants agreed that AccuCirc would be the device they would recommend due to protection of the glans from laceration and to the provision of a pre-assembled sterile kit that overcomes the need for additional supplies or autoclaving. All agreed that scaling up EIMC, integrating it with existing maternal child health services, will face significant challenges, not least of which is persuading already over-burdened providers to take on additional workload. These results will be useful to programmers considering introduction of EIMC services in sub-Saharan African settings.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

What device would be best for early infant male circumcision in east and southern Africa? Provider experiences and opinions with three different devices in Kenya

2017

View full text Add to dashboard Cite

show abstract

“…Because of the applicability of this device to large populations and the recommendation of circumcision as the main strategy for HIV prevention in some African countries, the United Nations has recently introduced randomized trials using hemostatic devices such as the Mogen in areas of difficult access by non-medical professionals, such as midwife nurses. 83,89 Other less-used devices can be cited: Zhenxi Rings ( Figure 11); Tara Klamp ( Figure 12); Smart Klamp ( Figure 13); and Shang Ring (Figure 14). The PrePex (Figure 15) is notable for its use in mass circumcision, without the need for anesthesia, for the prevention of HIV infection.…”

Section: Contraindicationsmentioning

confidence: 99%

Phimosis and Circumcision: Concepts, History, and Evolution

2018

View full text Add to dashboard Cite

Phimosis is classically characterized by the impossibility of completely withdrawing the foreskin and exposing the glans. A distal preputial narrowing occurs, which may be congenital or acquired. Excess foreskin and the presence of balanopreputial adhesions may be components of this spectrum. Circumcision corresponds to foreskin excision, one of the most commonly performed surgeries in boys, whether for medical or religious reasons. Such a procedure is considered sacred by many peoples around the world as a symbol of faith or even as a ritual of tribal emancipation. The appearance of the procedure in several places and times allowed the development of the surgical technique, today adapted to minimize complications and provide evident medical benefits. We present fundamental physiological and histological concepts, classically described, knowing the natural history of a potential disease. We discuss the emergence and development of surgical techniques still used today and identify factors that interfere with the disease and influence the treatment.

show abstract

“…In 2010, the WHO published the “Manual for Early Infant Male Circumcision under Local Anaesthesia [ 11 ],” which included pre-qualification of the Mogen clamp, Gomco clamp and Plastibell devices for EIMC. Since that time, several studies and demonstration projects have employed the Mogen clamp [ 9 , 10 , 12 – 14 ], which is the only device currently approved by the Kenyan Ministry of Health for EIMC [ 15 ]. However, other devices are being field tested and are under consideration for adoption in several African countries.…”

Section: Introductionmentioning

confidence: 99%

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

Bailey¹,

Nyaboke²,

Mackesy‐Amiti³

et al. 2018

PLoS ONE

View full text Add to dashboard Cite

BackgroundAs 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.MethodsProcedures 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.ResultsOf 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.ConclusionsThis 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.

show abstract

Randomised trial of early infant circumcision performed by clinical officers and registered nurse midwives using the Mogen clamp in Rakai, Uganda

Cited by 12 publications

References 13 publications

What device would be best for early infant male circumcision in east and southern Africa? Provider experiences and opinions with three different devices in Kenya

What device would be best for early infant male circumcision in east and southern Africa? Provider experiences and opinions with three different devices in Kenya

Phimosis and Circumcision: Concepts, History, and Evolution

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

Contact Info

Product

Resources

About