Surgical Technique — A Randomized Controlled Trial of Open Surgical vs. Minimally-invasive Voluntary Adult Male Circumcision
Citation(s)
Bailey RC, Egesah O, Rosenberg S Male circumcision for HIV prevention: a prospective study of complications in clinical and traditional settings in Bungoma, Kenya. Bull World Health Organ. 2008 Sep;86(9):669-77.
Bailey RC, Muga R, Poulussen R, Abicht H The acceptability of male circumcision to reduce HIV infections in Nyanza Province, Kenya. AIDS Care. 2002 Feb;14(1):27-40.
Elmore JM, Smith EA, Kirsch AJ Sutureless circumcision using 2-octyl cyanoacrylate (Dermabond): appraisal after 18-month experience. Urology. 2007 Oct;70(4):803-6.
Halperin DT, Fritz K, McFarland W, Woelk G Acceptability of adult male circumcision for sexually transmitted disease and HIV prevention in Zimbabwe. Sex Transm Dis. 2005 Apr;32(4):238-9.
Kim HH, Goldstein M High complication rates challenge the implementation of male circumcision for HIV prevention in Africa. Nat Clin Pract Urol. 2009 Feb;6(2):64-5. doi: 10.1038/ncpuro1279. Epub 2008 Dec 23.
Lagarde E, Dirk T, Puren A, Reathe RT, Bertran A Acceptability of male circumcision as a tool for preventing HIV infection in a highly infected community in South Africa. AIDS. 2003 Jan 3;17(1):89-95.
Lane V, Vajda P, Subramaniam R Paediatric sutureless circumcision: a systematic literature review. Pediatr Surg Int. 2010 Feb;26(2):141-4. doi: 10.1007/s00383-009-2475-y. Epub 2009 Aug 26. Review.
Scott BE, Weiss HA, Viljoen JI The acceptability of male circumcision as an HIV intervention among a rural Zulu population, Kwazulu-Natal, South Africa. AIDS Care. 2005 Apr;17(3):304-13.
World Health Organization Framework for Clinical Evaluation of Devices for Adult Male Circumcision. 2011.
World Health Organization Male circumcision: Global trends and determinants of prevalence, safety and acceptability, 2007
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.