Colon Disease — Computed Tomography vs. Endoscopy Study
Citation(s)
Aryaie AH, Singer JL, Fayezizadeh M, Lash J, Marks JM Efficacy of endoscopic management of leak after foregut surgery with endoscopic covered self-expanding metal stents (SEMS). Surg Endosc. 2017 Feb;31(2):612-617. doi: 10.1007/s00464-016-5005-8. Epub 2016 Jun 17.
Bakker IS, Grossmann I, Henneman D, Havenga K, Wiggers T Risk factors for anastomotic leakage and leak-related mortality after colonic cancer surgery in a nationwide audit. Br J Surg. 2014 Mar;101(4):424-32; discussion 432. doi: 10.1002/bjs.9395.
Blumetti J, Abcarian H Management of low colorectal anastomotic leak: Preserving the anastomosis. World J Gastrointest Surg. 2015 Dec 27;7(12):378-83. doi: 10.4240/wjgs.v7.i12.378.
Shamiyeh A, Szabo K, Ulf Wayand W, Zehetner J Intraoperative endoscopy for the assessment of circular-stapled anastomosis in laparoscopic colon surgery. Surg Laparosc Endosc Percutan Tech. 2012 Feb;22(1):65-7. doi: 10.1097/SLE.0b013e3182401e20.
Computed Tomography With Rectal Contrast and Early Endoscopy for the Detection of Anastomotic Leaks After Left Sided Colorectal Resection. A Single Center, Prospective Trial.
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.