Abstract
Over the last 20–30 years, the urology operating suite has undergone significant changes with the incorporation of new technologies, instruments, and innovative techniques aiming to decrease the invasiveness of surgical procedures. After the pioneering work of Clayman et al. in early 1990s, laparoscopic surgery spread quickly in the urological field. Since the early 2000s, robot-assisted surgery has also been increasingly adopted and even replaced standard laparoscopy in some instances. Laparoendoscopic single-site surgery (LESS) was developed with the goal to reproduce the same operative steps of laparoscopic surgery through a single incision, maximizing the cosmetic results and potentially causing less pain. More than 1,000 LESS urological procedures have been reported worldwide, encompassing almost the whole spectrum of urological surgery. With appropriate case selection, the safety of this approach appears to be similar to standard laparoscopy.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Clayman RV, Kavoussi LR, Soper NJ, et al. Laparoscopic nephrectomy. N Engl J Med. 1991;324(19):1370–1.
Abbou CC, Hoznek A, Salomon L, et al. Remote laparoscopic radical prostatectomy carried out with a robot. Report of a case. Prog Urol. 2000;10(4):520–3. Article in French.
Su LM. Robot-assisted radical prostatectomy: advances since 2005. Curr Opin Urol. 2010;20:130–5.
Box G, Averch T, Cadeddu J, Urologic NOTES Working Group, et al. Nomenclature of natural orifice translumenal endoscopic surgery (NOTES) and laparoendoscopic single-site surgery (LESS) procedures in urology. J Endourol. 2008;22(11):2575–81.
Kaouk JH, Autorino R, Kim FJ, et al. Laparoendoscopic single-site surgery in urology: worldwide multi-institutional analysis of 1076 cases. Eur Urol. 2011;60(5):998–1005.
Autorino R, Cadeddu JA, Desai MM, et al. Laparoendoscopic single-site and natural orifice transluminal endoscopic surgery in urology: a critical analysis of the literature. Eur Urol. 2011;59(1):26–45.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm#. Accessed on 13 Dec 2013.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm. Accessed on 13 Dec 2013.
Mastroianni AC. Liability, regulation and policy in surgical innovation: the cutting edge of research and therapy. Health Matrix Clevel. 2006;16(2):351–442.
Nat’l comm’n for the protection of human subjects of biomedical & behavioral research, The Belmont Report: ethical principles and guidelines for the protection of human subjects of research. 1979.
National Research Act, Pub. L. No. 93–348, 88 Stat. 342. 1974.
Kirby R, Challacombe B, Dasgupta P, et al. The importance of obtaining truly consensual informed consent. BJU Int. 2012;109(12):1743–4.
Brehaut JC, Carroll K, Elwyn G, et al. Informed consent documents do not encourage good-quality decision making. J Clin Epidemiol. 2012;65(7):708–24.
Enama ME, Hu Z, Gordon I, VRC 306 and 307 Consent Study Teams, et al. Randomization to standard and concise informed consent forms: development of evidence-based consent practices. Contemp Clin Trials. 2012;33(5):895–902.
Frader J, Caniano DA. Research and innovation in surgery. In: McCullough LB et al., editors. Surgical ethics. New York: Oxford University Press; 1998. p. 216. 220–21.
http://www.fda.gov/regulatoryinformation/guidances/ucm126420.htm. Accessed on 13 Dec 2013.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2017 Springer Science+Business Media New York
About this chapter
Cite this chapter
Laydner, H., Brandao, L.F., Kaouk, J.H. (2017). Consent and IRB Requirements. In: Kaouk, J., Stein, R., Haber, GP. (eds) Atlas of Laparoscopic and Robotic Single Site Surgery. Current Clinical Urology. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-3575-8_2
Download citation
DOI: https://doi.org/10.1007/978-1-4939-3575-8_2
Published:
Publisher Name: Humana Press, New York, NY
Print ISBN: 978-1-4939-3573-4
Online ISBN: 978-1-4939-3575-8
eBook Packages: MedicineMedicine (R0)