Evidence map›Paper›PMID 28715157›Full record

Trial reportJournal of the International AIDS Society2017

Use of the ShangRing circumcision device in boys below 18 years old in Kenya: results from a pilot study.

Quentin D Awori, Richard K Lee, Phillip S Li, Jared N Moguche, Dan Ouma, Betsy Sambai, Marc Goldstein, Mark A Barone

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in Journal of the International AIDS Society, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06273696 (Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06273696 completednot on this mapstarted 2019, after this paper: background citation

Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania

Typeobservational_patient_registrySponsorIntraHealth InternationalRan2019 to 2019Enrolled575ConditionsPenile Infection, Penile Haematoma, Penile Bleeding, DeformityArmsShangRing
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Review
  8. [Clinical effectiveness of disposable circumcision suture in children: a prospective randomized controlled trial].Nan fang yi ke da xue xue bao = Journal of Southern Medical University · 2018
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Quentin D AworiClinical Research Department, EngenderHealth, Nairobi, Kenya.
Richard K LeeCenter for Male Reproductive Medicine and Microsurgery, Department of Urology, Weill Cornell Medical College, New York, NY, USA.
Phillip S LiCenter for Male Reproductive Medicine and Microsurgery, Department of Urology, Weill Cornell Medical College, New York, NY, USA.
Jared N MogucheClinical Research Department, EngenderHealth, Nairobi, Kenya.
Dan OumaClinical Research Department, EngenderHealth, Nairobi, Kenya.
Betsy SambaiBiostatistics Department, Bon Sante Consulting, Nairobi, Kenya.
Marc GoldsteinCenter for Male Reproductive Medicine and Microsurgery, Department of Urology, Weill Cornell Medical College, New York, NY, USA.
Mark A BaroneClinical Research Department, EngenderHealth, New York, NY, USA.

Funding

Grand Challenges Canada 0139-01
6 · The paper itself

Abstract

introductionMale 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.

methodsA 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.

resultsNearly 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.

conclusionsOur 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.

Indexed as

Circumcision, MaleAdolescentBlack PeopleChildChild, PreschoolHIV InfectionsHumansInfantKenyaMalePilot ProjectsSafetyWorld Health Organizationadolescentscircumcision deviceinfantsMale circumcisionShangRing

Identifiers

PMID28715157
PMCPMC5515026

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.