Exploring the Ethical Gray Zone of Adopting New Surgical Techniques: The Case of Retzius-Sparing Radical Prostatectomy

Abstract

Developing, practicing, and implementing novel surgical techniques is imperative for all surgical specialties, but the differences between minor variations, major variations requiring specific informed consent, and human experimentation can sometimes be difficult for surgeons and institutional review boards (IRBs) to establish. Retzius-sparing prostatectomy is a technical modification of conventional prostatectomy, involving substantial changes in surgical steps and anatomic landmarks, with reported improvements in some early outcomes at the cost of a significant learning curve and some uncertainty in long-term oncologic outcomes. Here, we present a review of the ethical considerations of developing new surgical techniques and how they should apply to Retziussparing prostatectomy, the need for special informed consent when a surgeon begins to adopt this approach, and the need for IRB revision when collecting outcomes for publication. Case PresentationDr Scott is a urologist with more than 20 years of experience in robot-assisted laparoscopic prostatectomy (RALP). He recently learned about the Retzius-sparing technique for the treatment of prostate cancer while attending a presentation at a national conference. Some of the published and unpublished data presented suggested that the new technique improves postoperative continence and erectile function. The oncologic results appear not to differ substantially from the standard RALP. After talking to some colleagues who have used this technique, he decided to learn it with the goal of starting to use it at his academic institution. After a hands-on course and several surgeries under the supervision of an experienced surgeon, he believes he is ready to do it on his own. Dr Scott returns to his hospital but is unsure whether he should disclose to his patients that this is the first time he is performing this new procedure in the institution. He feels this could jeopardize patient confidence and the patient-physician relationship. He also does not know whether he should give the patients the option of choosing whether they want to be operated on with the previous technique or simply proceed with the standard informed consent he has been using for his previous RALPs. Finally, he is unsure whether he has an ethical duty to submit a protocol to an IRB to start performing