Simplifying the Shang Ring Technique for Circumcision of Men and Boys

Launched by ENGENDERHEALTH · Mar 10, 2015

Keywords

ClinConnect Summary

The study, to be conducted in two phases, will examine procedural and clinical outcomes, as well as participant and provider acceptability, of adaptations of the Shang Ring technique for male circumcision that would simplify its use and increase its acceptability.

* Phase I will be non-comparative for exploration of the no-flip technique for Shang Ring circumcision (i.e. all participants will be circumcised using the no-flip Shang Ring technique). Historical data from standard Shang Ring circumcisions conducted in Africa (Kenya, Uganda and Zambia) will be used as the comparison group. Men ...

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.

Trial Officials