The Essential Role of Informed Consent in Robot-Assisted Surgery

Laura M. Cascella, MA, CPHRM

Direct-to-consumer marketing of robot-assisted surgery (RAS) has generated patient interest in this technology. Patients may find statements about quicker recovery periods, less pain, smaller scars, and lower infection rates enticing. However, marketing and advertising efforts might paint an incomplete picture of the benefits and risks of RAS. Thus, informed consent plays an essential role in treatment discussions with patients who are considering robotic procedures.

Just like with any type of surgery, informed consent for RAS should involve a process in which the treating surgeon educates the patient about the procedure. The process should include disclosure of standard consent information — e.g., an explanation of the procedure, the healthcare providers who will be involved in the procedure, potential risks and benefits, alternative options, etc. — as well as information specific to RAS. For example, the surgeon should educate the patient about:

• The specific procedure and how it is performed
• The steps in the surgery that will involve the robot
• The potential risks of RAS in relation to equipment failures and malfunctions, such as:
  • System errors
  • Video imaging problems
  • Broken components
  • Electrical arcing, sparking, and charring
  • Unintended instrument movements¹
• The potential risks of RAS in relation to the patient’s specific condition and comorbidities
• The surgeon’s past experience with RAS in general and with the recommended robotic procedure specifically
• Alternative options or techniques for treatment and any information about how those techniques compare to RAS
• What will happen in the event of an emergency or complication (e.g., the surgeon will switch to open surgery or traditional laparoscopy) as well as any related risks

Taking the time to provide patients with these details and answer any questions can help ensure that they have the appropriate information to make informed decisions about their treatment. Following the informed consent process, surgeons should document these discussions in patients’ health records and include copies of any related consent forms.

To learn more about the potential risks of RAS and strategies to address them, see Robot-Assisted Surgery: Patient Safety and Liability Risks.

Endnotes

¹ Alemzadeh, H., Raman, J., Leveson, N., Kalbarczyk, Z., & Iyer, R. K. (2016). Adverse events in robotic surgery: A retrospective study of 14 years of FDA data. PLoS ONE, 11(4): e0151470. doi: https://doi.org/10.1371/journal.pone.0151470

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