Simplifying the Shang Ring Technique for Circumcision of Men and Boys
1 other identifier
interventional
574
1 country
2
Brief Summary
This is a research study in Kenya that will examine the outcomes of participants aged 10-15 and 16 and older; and provider acceptability of the Shang Ring technique for male circumcision that would simplify use. The study will be in two phases: Phase 1 will explore the no-flip technique that has been used in China but will be used for the first time in Africa. Phase 2 will be a randomized trial comparing use of tropical vs. injectable anesthesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2015
CompletedFirst Posted
Study publicly available on registry
March 17, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedAugust 3, 2016
August 1, 2016
1.2 years
February 5, 2015
August 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase I: Combined rate of moderate and severe adverse events (AEs) as a measure of safety of the no-flip technique for Shang Ring circumcision in males aged 10 years and older
We will evaluate the rate of moderate and severe AEs (combined) following Shang Ring MC using the no-flip technique based on clinical exam findings.
42 days
Phase 2: Pain measured with the visual analogue scale (VAS) experienced during the Shang Ring circumcision procedure with topical (EMLA Cream; lidocaine 2.5% and prilocaine 2.5%) vs. injectable (1% lidocaine) anesthesia.
The outcome metric for the primary outcome will be maximum pain reported to have been experienced by participants during the Shang Ring circumcision, assessed using the visual analogue scale (VAS), reported immediately after completion of the Shang Ring circumcision procedure
42 days
Secondary Outcomes (6)
Phase I: Ease of use of the Shang Ring with the no-flip technique as measured by MC procedure and device removal times and problems encountered during MC and removal procedures
42 days
Phase I: Satisfaction of the no-flip Shang Ring among study participants
42 days
Phase I: Occurrence of spontaneous detachment among those participants wearing the Shang Ring for more than 7 days days after circumcision
42 days
Phase I: Safety of spontaneous detachment as measured by AEs among those participants wearing the Shang Ring for more than 7 days after circumcision
42 days
Phase 2: Safety of topical vs. injectable anesthesia for local anesthesia during Shang Ring circumcision as measured by rates of moderate and severe AEs (combined rates)
42 days
- +1 more secondary outcomes
Study Arms (4)
Phase 1 - 7 Day Removal
ACTIVE COMPARATORShang Ring No Flip Technique: Removal of Shang Ring and assessment of healing 7 days after circumcision with no-flip technique.
Phase 1 - Delayed Removal
ACTIVE COMPARATORShang Ring No Flip Technique: Removal of ring or assessment of spontaneous detachment at more than 7 days to assess occurrence and safety following circumcision with the no-flip technique.
Phase 2 - Topical Anesthesia
ACTIVE COMPARATORComparison of Anesthesia methods for Shang Ring circumcision: Assessment of pain during and after surgery using topical anesthesia.
Phase 2 - Injectable Anesthesia
ACTIVE COMPARATORComparison of Anesthesia methods for Shang Ring circumcision: Assessment of pain during and after surgery when using injectable anesthesia.
Interventions
Comparison of healing times at 7 day and more than 7 days after circumcision.
Comparison of Anesthesia methods for Shang Ring circumcision. Comparison of pain during Shang Ring circumcision when using injectable vs. topical anesthesia.
Comparison of Anesthesia methods for Shang Ring circumcision. Comparison of pain during Shang Ring circumcision when using injectable vs. topical anesthesia.
Eligibility Criteria
You may qualify if:
- Aged 10 years and older;
- Uncircumcised upon clinical examination;
- In good general health;
- Free of genital ulcerations or other visible signs of sexually transmitted infections upon clinical examination;
- Participant and parent or legally acceptable representative (LAR) as applicable must be able to understand study procedures and requirements of study participation;
- Freely consents to participate in the study and signs a written informed consent form if 18 years of age or greater
- Accompanied by the parent/LAR, who freely consents and signs an informed consent form for participation of the child into the study for participants less than 18 years old;
- Assent from participant less than 18 years old who understand study procedure;
- Participant must agree to return to the study site for the full schedule of follow-up visits after his circumcision (or as appropriate the Parent or LAR must agree to bring the participant);
- Participant and parent/LAR as appropriate must agree to provide the study staff with an address, phone number, or other locator information while participating in the research study.
You may not qualify if:
- Has a known allergy or sensitivity to lidocaine or other local anesthesia;
- Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid;
- Has known bleeding/clotting disorder (e.g. hemophilia);
- Has any congenital genitourinary abnormality;
- Has an active genital infection, anatomic abnormality or other condition (e.g. diabetes or sickle cell anemia), which in the opinion of the surgeon, prevents the man from undergoing a circumcision as part of this study; or,
- Is currently participating in another biomedical research study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EngenderHealthlead
- Weill Medical College of Cornell Universitycollaborator
- Bon Sante Consulting Limitedcollaborator
- Kenya National AIDS & STI Control Programmecollaborator
- Kenya Ministry of Healthcollaborator
Study Sites (2)
Homa Bay Level IV County Hospital
Homa Bay, Homa Bay County, Kenya
Vipingo Health Center
Vipingo, Kilifi County, Kenya
Related Publications (2)
Al Hussein Alawamlh O, Awori QD, Barone MA, Kim SJ, Goldstein M, Li PS, Lee RK. No-flip ShangRing circumcision in 10-12 year old boys: Results from randomized clinical trials in Kenya. PLoS One. 2020 May 22;15(5):e0233150. doi: 10.1371/journal.pone.0233150. eCollection 2020.
PMID: 32442198DERIVEDAwori Q, Li PS, Lee RK, Ouma D, Oundo M, Barasa M, Obura N, Mwamkita D, Simba R, Oketch J, Nyangweso N, Maina M, Kiswi N, Kirui M, Chirchir B, Goldstein M, Barone MA. Use of topical versus injectable anaesthesia for ShangRing circumcisions in men and boys in Kenya: Results from a randomized controlled trial. PLoS One. 2019 Aug 14;14(8):e0218066. doi: 10.1371/journal.pone.0218066. eCollection 2019.
PMID: 31412032DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark A Barone, DVM, MS
EngenderHealth
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2015
First Posted
March 17, 2015
Study Start
May 1, 2015
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
August 3, 2016
Record last verified: 2016-08