Hysterectomy — The Use of Dye-less Cystoscopy in Assessing Urinary Tract Integrity During Hysterectomy
Citation(s)
American College of Obstetricians and Gynecologists ACOG Committee Opinion. Number 372. July 2007. The Role of cystourethroscopy in the generalist obstetrician-gynecologist practice. Obstet Gynecol. 2007 Jul;110(1):221-224. doi: 10.1097/01.AOG.0000263916.77694.20.
Chou MT, Wang CJ, Lien RC Prophylactic ureteral catheterization in gynecologic surgery: a 12-year randomized trial in a community hospital. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jun;20(6):689-93. doi: 10.1007/s00192-008-0788-3. Epub 2009 Jan 23.
Frankel J Accuracy of cystoscopy in the diagnosis of ureteral injury in benign gynecologic surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2004 Mar-Apr;15(2):75. doi: 10.1007/s00192-004-1144-x. Epub 2004 Feb 20. No abstract available.
Gilmour DT, Das S, Flowerdew G Rates of urinary tract injury from gynecologic surgery and the role of intraoperative cystoscopy. Obstet Gynecol. 2006 Jun;107(6):1366-72. doi: 10.1097/01.AOG.0000220500.83528.6e.
Teeluckdharry B, Gilmour D, Flowerdew G Urinary Tract Injury at Benign Gynecologic Surgery and the Role of Cystoscopy: A Systematic Review and Meta-analysis. Obstet Gynecol. 2015 Dec;126(6):1161-1169. doi: 10.1097/AOG.0000000000001096.
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.
