A surgeon's obligations when performing new procedures☆☆☆

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Abstract 

A junior member of the vascular surgery faculty has done two robotic abdominal aneurysmectomies. Although he attended a standard 2-day training course conducted by the instrument manufacturer, performed several similar procedures in the animal laboratory, and read all the recent pertinent literature, technical errors resulted in significant morbidity in his first two patients. He proposes to use the technique once again on a hospitalized patient. His troubled chairman has called you for an opinion on whether an ethical question has now arisen. There are no specific credentialling standards for robotic surgery at this institution. Where might we most expect to see an ethical problem in the surgeon's management of the new case?

The most likely ethical oversight is E, in disclosure of the surgeon's experience and outcomes with the robotic procedure. The least relevant answer is B; there is no evidence that patients have been improperly diagnosed or chosen only to expand the surgeon's case series with the new procedure.

Choice A implies skepticism about the adequacy of the brief manufacturer-provided courses typically used to introduce surgeons to new technology. Surgeons and trainers alike usually find that these concentrated sessions provide sufficient hands-on experience with novel instrumentation. This training method has been generally successful and is widely accepted by the profession as effective and ethical. Group acceptance does not always mean adequacy, however, and this is a process that should receive more professional scrutiny than it does. Choice C, concerning experienced operative assistance, is related to item A in the sense that most manufacturers of surgical high technology will send an experienced surgeon to assist, and continue training, in the operating room during a surgeon's first few procedures with a new method. There is no evidence that our surgeon rejected available help.

Choice D, respecting credentialing and IRB authorizations, approaches a more difficult realm. With no specific criteria for the conduct of robotic surgery (or likely many other new procedures) included in the medical center's credentialing process, the usual “full privilege” designation permits the procedure. Centers using this blanket privileging terminology are skirting their oversight responsibility. There is a potential ethical breach here, but it resides with the institution, not the surgeon.

Because this robotic procedure is not part of a structured research protocol, it will not normally be subject to IRB oversight, but a question arises about whether our case does in fact constitute experimentation. Innovation is sanctioned by the profession and society at large, which permits surgeons to make choices based upon clinical judgment. These choices include everyday decisions about prophylactic antibiotics, conduit selection, and which arteries to treat. Innovation becomes experimentation when the outcome cannot be reliably predicted. This is the case when a surgeon uses a complex new technology requiring new surgical skills and knowledge or when a surgeon attempts a procedure he has never done before.

The distinction changes the surgeon's obligations toward his patient regarding informed consent. Valid concerns that new surgical procedures are inadequately monitored have been articulated for many years.²

Innovations may be required unexpectedly to meet intraoperative exigencies, but patients must be informed if they are to become participants in experimentation. Our surgeon has not done enough robotic-assisted aneurysmectomies to develop a statistical outcome profile. His results can therefore not be reliably predicted, the hallmark of experimentation. He should specifically disclose his previous results to each patient whom he proposes to operate upon with this method until he can be confident of expectations. The ethical surgeon will not oversell the potential benefits of a new procedure while omitting what the patient most needs for informed consent—knowledge that the surgeon has very limited experience in the procedure and a high morbidity rate.

The literature confirms that fully experienced surgeons have a learning curve when even slightly different skill sets are needed, increasing the likelihood that early patients will not realize the same quality of results as those treated after more experience has been gained. Until a favorable surgical outcome can be realistically anticipated, the learning period is effectively experimental. For it to be warranted, there must be the prospect of knowledge to be gained and adequate assurance that standards of care are maintained.

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References 

1. Jones JW. Ethics of rapid surgical technological advancement. Ann Thorac Surg. 2000;69:676–677
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2. Spodick DH. Numerators without denominators. There is no FDA for the surgeon. JAMA. 1975;232:35–36
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3. Lytle BW, Cosgrove DM, Loop FD, et al.  Perioperative risk of bilateral internal mammary artery grafting: Analysis of 500 cases from 1971 to 1984. Circulation. 1986;74:11137–11141
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