PMID- 36113534
OWN - NLM
STAT- MEDLINE
DCOM- 20220920
LR  - 20221109
IS  - 2214-109X (Electronic)
IS  - 2214-109X (Linking)
VI  - 10
IP  - 10
DP  - 2022 Oct
TI  - ShangRing versus Mogen clamp for early infant male circumcision in eastern 
      sub-Saharan Africa: a multicentre, non-inferiority, adaptive, randomised 
      controlled trial.
PG  - e1514-e1522
LID - S2214-109X(22)00326-6 [pii]
LID - 10.1016/S2214-109X(22)00326-6 [doi]
AB  - BACKGROUND: Use of medical devices represents a unique opportunity to facilitate 
      scale-up of early infant male circumcision (EIMC) across sub-Saharan Africa. The 
      ShangRing, a circumcision device prequalified by WHO, is approved for use in 
      adults and adolescents and requires topical anaesthesia only. We aimed to 
      investigate the safety and efficacy of the ShangRing versus the Mogen clamp for 
      EIMC in infants across eastern sub-Saharan Africa. METHODS: In this multicentre, 
      non-inferiority, open-label, randomised controlled trial, we enrolled healthy 
      male infants (aged <60 days), with a gestational age of at least 37 weeks and a 
      birthweight of at least 2.5 kg, from 11 community and referral centres in Kenya, 
      Tanzania, and Uganda. Infants were randomly assigned (1:1) by a 
      computer-generated text message service to undergo EIMC by either the ShangRing 
      or the Mogen clamp. The primary endpoint was safety, defined as the number and 
      severity of adverse events (AEs), analysed in the intention-to-treat population 
      (all infants who underwent an EIMC procedure) with a non-inferiority margin of 2% 
      for the difference in moderate and severe AEs. This trial is registered with 
      Clinical. TRIALS: gov, NCT03338699, and is complete. FINDINGS: Between Sept 17, 
      2018, and Dec 20, 2019, a total of 1420 infants were assessed for eligibility, of 
      whom 1378 (97.0%) were enrolled. 689 (50.0%) infants were randomly assigned to 
      undergo EIMC by ShangRing and 689 (50.0%) by Mogen clamp. 43 (6.2%) adverse 
      events were observed in the ShangRing group and 61 (8.9%) in the Mogen clamp 
      group (p=0.078). The most common treatment-related AE was intraoperative pain 
      (Neonatal Infant Pain Scale score >/=5), with 19 (2.8%) events in the ShangRing and 
      23 (3.3%) in the Mogel clamp group. Rates of moderate and severe AEs were similar 
      between both groups (29 [4.2%] in the ShangRing group vs 30 [4.4%] in the Mogen 
      clamp group; difference -0.1%; one-sided 95% CI upper limit of 1.7%; p=0.89). No 
      treatment-related deaths were reported. INTERPRETATION: Use of the ShangRing 
      device for EIMC showed safety, achieved high caregiver satisfaction, and did not 
      differ from the Mogen clamp in other key measures. The ShangRing could be used by 
      health systems and international organisations to further scale up EIMC across 
      sub-Saharan Africa. FUNDING: Bill & Melinda Gates Foundation.
CI  - Copyright (c) 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access 
      article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights 
      reserved.
FAU - Basourakos, Spyridon P
AU  - Basourakos SP
AD  - Department of Urology, Weill Cornell Medicine, New York-Presbyterian Hospital, 
      New York, NY, USA.
FAU - Nang, Quincy G
AU  - Nang QG
AD  - Department of Urology, Weill Cornell Medicine, New York-Presbyterian Hospital, 
      New York, NY, USA.
FAU - Ballman, Karla V
AU  - Ballman KV
AD  - Division of Biostatistics, Department of Population Health Sciences, Weill 
      Cornell Medicine, New York-Presbyterian Hospital, New York, NY, USA.
FAU - Al Awamlh, Omar Al Hussein
AU  - Al Awamlh OAH
AD  - Department of Urology, Weill Cornell Medicine, New York-Presbyterian Hospital, 
      New York, NY, USA.
FAU - Punjani, Nahid
AU  - Punjani N
AD  - Department of Urology, Weill Cornell Medicine, New York-Presbyterian Hospital, 
      New York, NY, USA.
FAU - Ho, Kaylee
AU  - Ho K
AD  - Division of Biostatistics, Department of Population Health Sciences, Weill 
      Cornell Medicine, New York-Presbyterian Hospital, New York, NY, USA.
FAU - Barone, Mark A
AU  - Barone MA
AD  - Center for Biomedical Research, Population Council, New York, NY, USA.
FAU - Awori, Quentin D
AU  - Awori QD
AD  - Population Council, Nairobi, Kenya.
FAU - Ouma, Daniel
AU  - Ouma D
AD  - Population Council, Nairobi, Kenya.
FAU - Oketch, Jairus
AU  - Oketch J
AD  - Homa Bay Teaching and Referral Hospital, Nairobi, Kenya.
FAU - Christensen, Alice E
AU  - Christensen AE
AD  - Jhpiego Tanzania, Dar es Salaam, Tanzania.
FAU - Hellar, Augustino
AU  - Hellar A
AD  - Jhpiego Tanzania, Dar es Salaam, Tanzania.
FAU - Makokha, Maende
AU  - Makokha M
AD  - Jhpiego Tanzania, Dar es Salaam, Tanzania.
FAU - Isangu, Alphonce
AU  - Isangu A
AD  - Jhpiego Tanzania, Dar es Salaam, Tanzania.
FAU - Salim, Robert
AU  - Salim R
AD  - Ministry of Health, Tanzania.
FAU - Lija, Jackson
AU  - Lija J
AD  - Ministry of Health, Tanzania.
FAU - Gray, Ronald H
AU  - Gray RH
AD  - Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD, USA.
FAU - Kiboneka, Stephen
AU  - Kiboneka S
AD  - Uganda Virus Research Institute, Entebbe, Uganda.
FAU - Anok, Aggrey
AU  - Anok A
AD  - Uganda Virus Research Institute, Entebbe, Uganda.
FAU - Kigozi, Godfrey
AU  - Kigozi G
AD  - Uganda Virus Research Institute, Entebbe, Uganda.
FAU - Nakabuye, Regina
AU  - Nakabuye R
AD  - Uganda Virus Research Institute, Entebbe, Uganda.
FAU - Ddamulira, Charles
AU  - Ddamulira C
AD  - Uganda Virus Research Institute, Entebbe, Uganda.
FAU - Mulooki, Andrew
AU  - Mulooki A
AD  - Uganda Virus Research Institute, Entebbe, Uganda.
FAU - Odiya, Silas
AU  - Odiya S
AD  - Uganda Virus Research Institute, Entebbe, Uganda.
FAU - Nazziwa, Rose
AU  - Nazziwa R
AD  - Uganda Virus Research Institute, Entebbe, Uganda.
FAU - Goldstein, Marc
AU  - Goldstein M
AD  - Department of Urology, Weill Cornell Medicine, New York-Presbyterian Hospital, 
      New York, NY, USA.
FAU - Li, Philip S
AU  - Li PS
AD  - Department of Urology, Weill Cornell Medicine, New York-Presbyterian Hospital, 
      New York, NY, USA. Electronic address: psli@med.cornell.edu.
FAU - Lee, Richard K
AU  - Lee RK
AD  - Department of Urology, Weill Cornell Medicine, New York-Presbyterian Hospital, 
      New York, NY, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03338699
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Lancet Glob Health
JT  - The Lancet. Global health
JID - 101613665
SB  - IM
CIN - Lancet Glob Health. 2022 Oct;10(10):e1377-e1378. PMID: 36113516
MH  - Adolescent
MH  - Adult
MH  - *Anesthesia
MH  - *Circumcision, Male/adverse effects
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Kenya
MH  - Male
MH  - Pain/etiology
MH  - Uganda
PMC - PMC9638032
COIS- Declaration of interests We declare no competing interests.
EDAT- 2022/09/17 06:00
MHDA- 2022/09/21 06:00
PMCR- 2022/09/13
CRDT- 2022/09/16 19:03
PHST- 2021/07/12 00:00 [received]
PHST- 2022/06/18 00:00 [revised]
PHST- 2022/07/18 00:00 [accepted]
PHST- 2022/09/17 06:00 [pubmed]
PHST- 2022/09/21 06:00 [medline]
PHST- 2022/09/16 19:03 [entrez]
PHST- 2022/09/13 00:00 [pmc-release]
AID - S2214-109X(22)00326-6 [pii]
AID - 10.1016/S2214-109X(22)00326-6 [doi]
PST - ppublish
SO  - Lancet Glob Health. 2022 Oct;10(10):e1514-e1522. doi: 
      10.1016/S2214-109X(22)00326-6.