PMID- 28715157
OWN - NLM
STAT- MEDLINE
DCOM- 20171122
LR  - 20221207
IS  - 1758-2652 (Electronic)
IS  - 1758-2652 (Linking)
VI  - 20
IP  - 1
DP  - 2017 Jul 12
TI  - Use of the ShangRing circumcision device in boys below 18 years old in Kenya: 
      results from a pilot study.
PG  - 21588
LID - 10.7448/IAS.20.1.21588 [doi]
LID - 21588
AB  - INTRODUCTION: Male circumcision is a proven prevention strategy against the 
      spread of HIV. The World Health Organization's new 2016-2021 strategic framework 
      on voluntary medical male circumcision (VMMC) targets 90% of males aged 
      10-29 years to receive circumcision by 2021 in 14 priority sub-Saharan countries 
      while anticipating an increase in the demand for infant circumcision. It also 
      states that the use of circumcision devices is a safe and efficient innovation to 
      accelerate attainment of these goals. The primary objective of this pilot study 
      was to evaluate the safety and acceptability of the ShangRing, a novel 
      circumcision device, in boys below 18 years of age. METHODS: A total of 80 boys, 
      3 months to 17 years old, were circumcised using the no-flip ShangRing technique. 
      All rings were removed 5-7 days later. Participants were evaluated weekly until 
      the wound was completely healed. Data on procedure times, adverse events (AEs), 
      time to clinical wound healing and satisfaction were recorded and analysed. 
      RESULTS: Nearly all (79/80, 98.8%) circumcisions were successfully completed 
      using the no-flip ShangRing technique without complications. In one (1.2%) case, 
      the outer ring slipped off after the foreskin was removed and the procedure was 
      completed by stitching. The mean circumcision and ring removal times were 
      7.4 +/- 3.2 and 4.4 +/- 4.2 min, respectively. There were four (5%) moderate AEs, 
      which were managed conservatively. No severe AEs occurred. The mean time to 
      complete clinical healing was 29.8 +/- 7.3 days. Participants or their parents 
      liked ShangRing circumcision because it improved hygiene, was quick and possessed 
      an excellent cosmetic appearance. Most (72/80, 94.7%) were very satisfied with 
      the appearance of the circumcised penis, and all (100%) said they would recommend 
      circumcision to others. CONCLUSIONS: Our results suggest that no-flip ShangRing 
      VMMC is safe and acceptable in boys below 18 years of age. Our results are to be 
      compared those seen following ShangRing VMMC in African men. Further study with 
      larger sample sizes are needed to explore the scalability of the ShangRing in 
      larger paediatric cohorts in Africa. We believe that the ShangRing has great 
      potential for use in all age groups from neonates to adults, which would simplify 
      device implementation.
FAU - Awori, Quentin D
AU  - Awori QD
AD  - Clinical Research Department, EngenderHealth, Nairobi, Kenya.
FAU - Lee, Richard K
AU  - Lee RK
AD  - Center for Male Reproductive Medicine and Microsurgery, Department of Urology, 
      Weill Cornell Medical College, New York, NY, USA.
FAU - Li, Phillip S
AU  - Li PS
AD  - Center for Male Reproductive Medicine and Microsurgery, Department of Urology, 
      Weill Cornell Medical College, New York, NY, USA.
FAU - Moguche, Jared N
AU  - Moguche JN
AD  - Clinical Research Department, EngenderHealth, Nairobi, Kenya.
FAU - Ouma, Dan
AU  - Ouma D
AD  - Clinical Research Department, EngenderHealth, Nairobi, Kenya.
FAU - Sambai, Betsy
AU  - Sambai B
AD  - Biostatistics Department, Bon Sante Consulting, Nairobi, Kenya.
FAU - Goldstein, Marc
AU  - Goldstein M
AD  - Center for Male Reproductive Medicine and Microsurgery, Department of Urology, 
      Weill Cornell Medical College, New York, NY, USA.
FAU - Barone, Mark A
AU  - Barone MA
AD  - Clinical Research Department, EngenderHealth, New York, NY, USA.
LA  - eng
GR  - 0139-01/Grand Challenges Canada/International
PT  - Clinical Trial
PT  - Journal Article
PL  - Switzerland
TA  - J Int AIDS Soc
JT  - Journal of the International AIDS Society
JID - 101478566
SB  - IM
MH  - Adolescent
MH  - Black People
MH  - Child
MH  - Child, Preschool
MH  - *Circumcision, Male/adverse effects/methods
MH  - HIV Infections/prevention & control
MH  - Humans
MH  - Infant
MH  - Kenya
MH  - Male
MH  - Pilot Projects
MH  - Safety
MH  - World Health Organization
PMC - PMC5515026
OTO - NOTNLM
OT  - Male circumcision
OT  - ShangRing
OT  - adolescents
OT  - circumcision device
OT  - infants
COIS- The authors declare no potential conflicts of interest with respect to the 
      research, authorship and/or publication of this article.
EDAT- 2017/07/18 06:00
MHDA- 2017/11/29 06:00
PMCR- 2017/07/12
CRDT- 2017/07/18 06:00
PHST- 2017/07/18 06:00 [entrez]
PHST- 2017/07/18 06:00 [pubmed]
PHST- 2017/11/29 06:00 [medline]
PHST- 2017/07/12 00:00 [pmc-release]
AID - 1348093 [pii]
AID - 10.7448/IAS.20.1.21588 [doi]
PST - ppublish
SO  - J Int AIDS Soc. 2017 Jul 12;20(1):21588. doi: 10.7448/IAS.20.1.21588.