Addressing the ethical grey zone in surgery: a framework for identification and safe introduction of novel surgical techniques and procedures

ANZ Journal of Surgery - Tập 89 Số 6 - Trang 634-638 - 2019
Kilian G. M. Brown1,2,3, Michael J. Solomon1,2,3,4, Jane Young2,3,4, Michael Seco5,4, Paul G. Bannon5,2,4
1Department of Colorectal Surgery, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
2Institute of Academic Surgery, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
3Surgical Outcomes Research Centre (SOuRCe), Sydney, New South Wales, Australia
4The University of Sydney, Sydney, New South Wales, Australia
5Department of Cardiothoracic Surgery, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia

Tóm tắt

While the introduction of new surgical techniques can radically improve patient care, they may equally expose patients to unforeseen harms associated with untested procedures. The enthusiastic uptake of laparoscopic cholecystectomy in the early 1990s saw a dramatic increase in the rate of common bile duct injuries, and was described by Alfred Cuschieri as ‘the biggest unaudited free‐for‐all in the history of surgery’ due to ‘a lack of effective centralised control’. Whether a new surgical intervention is considered an acceptable ‘minor’ variation of an established procedure, or is sufficiently ‘novel’ to constitute experimentation on human subjects is often unclear. Furthermore, once a new technique is identified as experimental, there is no agreed protocol for safety evaluation in a first‐in‐human setting. In phase I (first‐in‐human) pharmacological trials only small, single arm cohorts of highly selected patients are enrolled in order to establish the safety profile of a new drug. This exposes only a small number of patients to the unknown or unforeseen risks that may be associated with a new agent, in a highly regulated and scientifically rigorous manner. There is no equivalent study design for the introduction of new and experimental surgical procedures. This article proposes a practical stepwise approach to the safe introduction of new surgical procedures that surgeons and surgical departments can adopt. It includes criteria for new surgical techniques which require formal prospective ethical evaluation, and a novel study design for conducting a safety evaluation at the ‘first in human’ stage.

Từ khóa


Tài liệu tham khảo

10.1016/S0002-9610(05)80956-0

Gouma DJ, 1994, Bile duct injury during laparoscopic and conventional cholecystectomy, J. Am. Coll. Surg., 178, 229

10.1007/BF00295923

10.1016/S0002-9610(05)80397-6

10.1016/S0002-9610(99)80104-4

Royal Australiasian College of Surgeons/ASERNIP‐S. General Guidelines for Assessing Approving & Introducing New Surgical Procedures into a Hospital or Health Service. [Cited 8 Feb 2018]. Available from URL:https://www.surgeons.org/media/297973/REA_ASE_3103_P_General_Guidelines_for_Assessing_Approving_Introducing_New_Surgical_Procedures_into_a_Hospital_or_Health_Service.pdf

10.1016/j.jamcollsurg.2008.02.011

10.1007/s00464-014-3587-6

10.1016/S0140-6736(09)61116-8

10.1097/01.sla.0000242706.91771.ce

Belmont1979. The Belmont Report. Office of the Secretary. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979 April.

Mastroianni AC, 2006, Liability, regulation and policy in surgical innovation: the cutting edge of research and therapy, Health Matrix, 16, 351

10.1016/S1072-7515(02)01153-5

10.1258/jrsm.2008.080308

10.1007/s002689900580

Tan VK, 2011, An approach to the ethical evaluation of innovative surgical procedures, Ann. Acad. Med. Singapore, 40, 26, 10.47102/annals-acadmedsg.V40N1p26

10.1093/jnci/djp079

10.1158/1078-0432.CCR-09-1961

10.1016/j.ijrobp.2008.12.075

10.1016/S0360-3016(03)01385-3

10.1016/S1743-9191(13)60003-5

10.1097/SLA.0b013e3181b13ca2

10.1016/j.jtcvs.2011.04.039

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Thông tin xuất bản

ANZ Journal of Surgery

Tập 89 Số 6

634-638

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