Abstract
When physicians and surgeons investigate new drugs or devices, they must adhere to stringent regulatory standards governing human experimentation. Although these standards and regulations are not perfect, they serve to protect the interests of patients and research subjects. By contrast, few standards or regulations exist for innovative procedures, including new surgical techniques. Surgeons apply the term “innovative surgery” to describe practices ranging from minor technical modifications in standard procedures to nonvalidated investigational approaches indistinguishable from human research. By focusing on recent innovations in surgery, including colorectal surgery, this article proposes an ethical model of surgical innovation that protects patients while maintaining professional self-regulation of surgical advances.
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REFERENCES
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont report: ethical principles and guidelines for the protection of human subjects of research. Washington: Dept. of Health, Education, and Welfare, National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978
U.S. Code of Federal Regulations, 45 C.F.R. Part 46 (Nov. 2001)
Messerklinger W. Endoscopy of the nose. Baltimore: Urban & Schwarzenberg, 1978
DW Kennedy SJ Zinreich AE Rosenbaum ME Johns (1985) ArticleTitleFunctional endoscopic sinus surgery: theory and diagnostic evaluation Arch Otolaryngol 111 576–82
Vining EM, Kennedy DW. The transmigration of endoscopic sinus surgery from Europe to the United States. Ear Nose Throat J 1994; 73: 456-458, 460
DG Durr M Desrosiers (2003) ArticleTitleEvidence-based endoscopic sinus surgery J Otolaryngol 32 101–6 Occurrence Handle12866594
JE Lieu JF Piccirillo (2003) ArticleTitleMethodologic assessment of studies on endoscopic sinus surgery Arch Otolaryngol Head Neck Surg 129 1230–5 Occurrence Handle10.1001/archotol.129.11.1230 Occurrence Handle14623756
F Dubois G Berthelot H Levard (1991) ArticleTitleLaparoscopic cholecystectomy: historic perspective and personal experience Surg Laparosc Endosc Percutan Tech 1 52–7 Occurrence Handle1:STN:280:ByuD1c%2FksFI%3D
JB McKernan (1999) ArticleTitleOrigin of laparoscopic cholecystectomy in the USA: personal experience World J Surg 23 332–3 Occurrence Handle1:STN:280:DyaK1M7lsFejtg%3D%3D Occurrence Handle10030855
SM Strasberg PA Ludbrook (2003) ArticleTitleWho oversees innovative practice? Is there a structure that meets the monitoring needs of new techniques? J Am Coll Surg 196 938–48 Occurrence Handle10.1016/S1072-7515(03)00112-1 Occurrence Handle12788432
JS Barkun AN Barkun JS Sampalis et al. (1992) ArticleTitleRandomised controlled trial of laparoscopic versus mini cholecystectomy. The McGill Gallstone Treatment Group Lancet 340 1116–9 Occurrence Handle10.1016/0140-6736(92)93148-G Occurrence Handle1:STN:280:ByyD287ltlQ%3D Occurrence Handle1359210
AJ McMahon IT Russell JN Baxter et al. (1994) ArticleTitleLaparoscopic versus minilaparotomy cholecystectomy: a randomized trial Lancet 343 135–8 Occurrence Handle10.1016/S0140-6736(94)90932-6 Occurrence Handle1:STN:280:ByuC3cvjslw%3D Occurrence Handle7904002
HR Bernard TW Hartman (1993) ArticleTitleComplications after laparoscopic cholecystectomy Am J Surg 165 533–5 Occurrence Handle1:STN:280:ByyB2czlsVY%3D Occurrence Handle8480897
AM Davidoff TN Pappas EA Murray et al. (1992) ArticleTitleMechanisms of major biliary injury during laparoscopic cholecystectomy Ann Surg 215 196–202 Occurrence Handle1:STN:280:By2C1c7itlE%3D Occurrence Handle1531913
Anonymous. A prospective analysis of 1518 laparoscopic cholecystectomies. The Southern Surgeons Club. N Engl J Med 1991;324:1073–8
M Jacobs JC Verdeja HS Goldstein (1991) ArticleTitleMinimally invasive colon resection (laparoscopic colectomy) Surg Laparosc Endosc 1 144–50 Occurrence Handle1:STN:280:ByuD1c%2FkslA%3D Occurrence Handle1688289
DL Fowler SA White (1991) ArticleTitleLaparoscopy-assisted sigmoid resection Surg Laparosc Endosc 1 183–8 Occurrence Handle1:STN:280:ByuD1c%2FkvVU%3D Occurrence Handle1669400
JC Weeks H Nelson S Gelber D Sargent G Schroeder (2002) ArticleTitleClinical Outcomes of Surgical Theory (COST) Study Group. Short-term quality-of-life outcomes following laparoscopic-assisted colectomy vs open colectomy for colon cancer: a randomized trial JAMA 287 321–8 Occurrence Handle10.1001/jama.287.3.321 Occurrence Handle11790211
JA Kieran MJ Curet (2004) ArticleTitleLaparoscopic colon resection for colon cancer J Surg Res 117 79–91 Occurrence Handle10.1016/j.jss.2003.11.025 Occurrence Handle15013718
ER Winslow JW Fleshman EH Birnbaum LM Brunt (2002) ArticleTitleWound complications of laparoscopic vs open colectomy Surg Endosc 16 1420–5 Occurrence Handle10.1007/s00464-002-8837-3 Occurrence Handle1:STN:280:DC%2BD38nktlWltw%3D%3D Occurrence Handle12085142
SD Wexner SM Cohen A Ulrich P Reissman (1995) ArticleTitleLaparoscopic colorectal surgery—are we being honest with our patients? Dis Colon Rectum 38 723–7 Occurrence Handle1:STN:280:ByqA3s7gvVU%3D Occurrence Handle7607032
InstitutionalAuthorNameClinical Outcomes of Surgical Therapy Study Group (2004) ArticleTitleA comparison of laparoscopically assisted and open colectomy for colon cancer N Engl J Med 350 2050–9
FD Moore (1988) ArticleTitleThree ethical revolutions: ancient assumptions remodeled under pressure of transplantation Transplant Proc 20 1061–7 Occurrence Handle1:STN:280:BieC2Mbns10%3D Occurrence Handle3279601
PA Singer M Siegler PF Whitington et al. (1989) ArticleTitleEthics of liver transplantation with living donors N Engl J Med 321 620–2 Occurrence Handle1:STN:280:BiaA2cvhvFU%3D Occurrence Handle2668769
CF Broelsch PF Whitington JC Emond et al. (1991) ArticleTitleLiver transplantation in children from living related donors. Surgical techniques and results Ann Surg 214 428–37 Occurrence Handle1:STN:280:By2D287isVA%3D Occurrence Handle1953097
JM Millis DC Cronin LM Brady et al. (2000) ArticleTitlePrimary living-donor liver transplantation at the University of Chicago: technical aspects of the first 104 recipients Ann Surg 232 104–11 Occurrence Handle10.1097/00000658-200007000-00015 Occurrence Handle1:STN:280:DC%2BD3czitVGjsg%3D%3D Occurrence Handle10862202
X Rogiers M Burdelski CE Broelsch (1994) ArticleTitleLiver transplantation from living donors Br J Surg 81 1251–3 Occurrence Handle1:STN:280:ByqD2c7hslw%3D Occurrence Handle7953383
Y Inomata K Tanaka S Uemoto et al. (1999) ArticleTitleLiving donor liver transplantation: an 8-year experience with 379 consecutive cases Transplant Proc 31 381 Occurrence Handle10.1016/S0041-1345(98)01671-6 Occurrence Handle1:STN:280:DyaK1M7ot1Ohsw%3D%3D Occurrence Handle10083152
Cronin DC, Siegler M. Ethics in living donor transplantation. In: Busuttil RW, Klintman GB, eds. Transplantation of the liver. 2nd ed. Philadelphia: W. B. Saunders, 2005
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Marron, J., Siegler, M. Ethical Issues in Innovative Colorectal Surgery. Dis Colon Rectum 48, 1109–1113 (2005). https://doi.org/10.1007/s10350-004-0892-5
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DOI: https://doi.org/10.1007/s10350-004-0892-5