An Approach to the Ethical Evaluation of Innovative Surgical Procedures

Reitsma AM, Moreno JD. Ethical regulations for innovative surgery: the last frontier? J Am Coll Surg 2002;194:792-801.

Spodick DH. Numerators without denominators. There is no FDA for the surgeon. JAMA 1975;232:35-6.

Horton R. Surgical research or comic opera: questions, but few answers. Lancet 1996;347:984-5.

Stirrat GM, Farrow SC, Farndon J, Dwyer N. The challenge of evaluating surgical procedures. Ann R Coll Surg Engl 1992;74:80-4.

Dimick JB, Diener-West M, Lipsett PA. Negative results of randomized clinical trials published in the surgical literature: equivalency or error? Arch Surg 2001;136:796-800.

London AJ, Kadane JB. Placebos that harm: sham surgery controls in clinical trials. Stat Methods Med Res 2002;11:413-27.

Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987;317:141-5.

Fins JJ. Surgical innovation and ethical dilemmas: precautions and proximity. Cleve Clin J Med 2008;75Suppl 6:S7-12.

Reeves B. Health-technology assessment in surgery. Lancet 1999;353 Suppl 1:SI3-5.

Jordan WD Jr, Sampson LK, Iyer S, Anderson PG, Lyle K, Brown RJ, et al. Abdominal aortic aneurysm repair via percutaneous endovascular stenting in the swine model. Am Surg 1998;64:1070-3.

Yoshioka T, Wright KC, Wallace S, Lawrence DD Jr, Gianturco C. Self expanding endovascular graft: an experimental study in dogs. AJR Am J Roentgenol 1988;151:673-6.

Mirich D, Wright KC, Wallace S, Yoshioka T, Lawrence DD Jr, Charnsangavej C, et al. Percutaneously placed endovascular grafts for aortic aneurysms: feasibility study. Radiology 1989;170(3 Pt 2):1033-7.

Chuter TA, Donayre C, Wendt G. Bifurcated stent-grafts for endovascular repair of abdominal aortic aneurysm. Preliminary case reports. Surg Endosc 1994;8:800-2.

Eliason JL, Upchurch GR Jr. Endovascular treatment of aortic aneurysms: state of the art. Curr Treat Options Cardiovasc Med 2009;11:136-45.

May J, White GH, Harris JP. Endoluminal repair of abdominal aortic aneurysms — state of the art. Eur J Radiol 2001;39:16-21.

Greenhalgh RM, Brown LC, Powell JT, Thompson SG, Epstein D, Sculpher MJ. Endovascular versus open repair of abdominal aortic aneurysm. N Engl J Med 2010;362:1863-71.

Schauer PR, Burguera B, Ikramuddin S, Cottam D, Gourash W, Hamad G, et al. Effect of laparoscopic Roux-en Y gastric bypass on type 2 diabetes mellitus. Ann Surg 2003;238:467-84;discussion 84-5.

Wajchenberg B, Cohen R, Schiavon C, et al. Laparoscopic duodenal jejunal bypass in the treatment of type 2 diabetes mellitus in patients with BMI <34. Initial results. Abstract presented at: 68th Annual Scientific Sessions of the American Diabetes Association; June 6-10, 2008; San Francisco, CA. Abstract 1454-P.

Effects of radiotherapy and surgery in early breast cancer. An overview of the randomized trials. Early Breast Cancer Trialists' Collaborative Group. N Engl J Med 1995;333:1444-55.

Neumayer L, Giobbie-Hurder A, Jonasson O, Fitzgibbons R Jr, Dunlop D, Gibbs J, et al. Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med 2004;350:1819-27.

McKneally MF. Ethical problems in surgery: innovation leading to unforeseen complications. World J Surg 1999;23:786-8.