Weight Loss — Endoscopic Gastric Plication for Weight Loss in Morbidly Obese Patients Prior to Incisional Hernia Repair
Citation(s)
Abu Dayyeh BK, Rajan E, Gostout CJ Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc. 2013 Sep;78(3):530-5. doi: 10.1016/j.gie.2013.04.197. Epub 2013 May 24.
Brethauer SA, Chand B, Schauer PR, Thompson CC Transoral gastric volume reduction as intervention for weight management: 12-month follow-up of TRIM trial. Surg Obes Relat Dis. 2012 May-Jun;8(3):296-303. doi: 10.1016/j.soard.2011.10.016. Epub 2011 Nov 9.
Brethauer SA, Chand B, Schauer PR, Thompson CC Transoral gastric volume reduction for weight management: technique and feasibility in 18 patients. Surg Obes Relat Dis. 2010 Nov-Dec;6(6):689-94. doi: 10.1016/j.soard.2010.07.012. Epub 2010 Aug 6.
Coté GA, Edmundowicz SA Emerging technology: endoluminal treatment of obesity. Gastrointest Endosc. 2009 Nov;70(5):991-9. doi: 10.1016/j.gie.2009.09.016. Review.
Funk LM, Perry KA, Narula VK, Mikami DJ, Melvin WS Current national practice patterns for inpatient management of ventral abdominal wall hernia in the United States. Surg Endosc. 2013 Nov;27(11):4104-12. doi: 10.1007/s00464-013-3075-4. Epub 2013 Jul 17.
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.
