Laparoscopic and other colorectal trials: ethics of the learning curve

Introduction of increasingly complex new surgical procedures presents new challenges in practical and ethical terms. In this edition of the journal, Meagher et al.’s focus is on the large numbers of patients excluded from recent multicentre trials comparing large bowel resection for cancer performed using laparoscopic techniques as opposed to open laparotomy, because the surgeons involved were regarded as still being on their ‘learning curve’. For 5680 patients included in the analysis, they identified 10 605 that had been excluded from it. And this does raise a number of questions. As the authors relate, there is ample evidence of the existence of learning curves with new surgical techniques. It seems a given that the number of cases required for a surgeon to graduate from the curve would vary depending on both the complexity and the novelty of the procedure, and that seems to be the case. From various contexts, estimates from around thirty to several hundred cases have been proposed. Two other features of learning curves seem universal; the curve is longer when the procedure is truly new, both for the surgeon and the institution, and is truncated when learning occurs in an environment when others, both surgeons and institutions, have already reached full proficiency. The exclusions make most sense from a scientific perspective, and they probably contributed to the reliability of the results. From an ethics perspective, the responsibilities of a surgeon who is innovating (and I think that is what has been happening here) are clear. There are three main strands to them. First, there must be a reasonable expectation that the innovation will be an improvement. Second, the patient must be fully informed, regarding both the surgeon’s level of experience with the innovation, and any reasonably foreseeable risks the innovation might entail. The third strand is a requirement for the outcome to be measured, recorded and reported. Formal frameworks exist for the management of new health technologies and services in both public and private hospitals, and they tend to get suitably implemented whenever a proposed innovation is dramatic. For example, a proper Participant Information and Consent Form was required when transcatheter aortic valve implantation was introduced into clinical practice in Central Sydney Area Health Service a decade ago. However, the governance processes tend not to be triggered when the innovation is minor or incremental. In these situations, reliance defers to the individual’s professional responsibility. Meagher et al.’s lament in part relates to the loss of opportunities to learn from the outcomes relating to the surgeons’ learning curves. I agree, recognizing that a clinical trial setting should be ideal for satisfying the ethical requirement for learning curve outcomes. The elephantine concern, unique to surgery for a potentially lethal condition (and perhaps in part a reason for the exclusions), is the prospect of the loss of “an opportunity to cure” because surgeons are on their learning curves. This would be something worth knowing about, and maybe an opportunity to find out has been missed with the exclusion of so many patients. In 1984, Caplan suggested that, because they had benefited greatly from biomedical research, individuals in modern society might have a moral obligation to participate in it. Other bioethicists have since continued in the same vein. However, in contemporary bioethics, it is increasingly inappropriate for any healthcare professional to make paternalistic decisions: patients have the right to choose for themselves. In discussing a laparoscopic approach with their patients with colorectal cancer, surgeons need to raise the prospect that the risk of failure to cure may be somewhat greater with that approach, both in the hands of less experienced surgeons (because we really do not know) and even in experienced hands for rectal cancer (at least for the time being). It is then up to the patient to decide whether to proceed, given the other potential benefits of the approach. With that done, it seems more ethically correct to include such patients in clinical trials rather than exclude them.