Risk Tips for Robotic-Assisted Surgical Procedures

PMP’s article Rise of the Machines: Robotic-Assisted Surgery discusses the increasing prevalence of this type of intervention. Since the first reported robotically assisted laparoscopic radical prostatectomy by Binder J et al in 2000, the technique has revolutionised laparoscopic surgery. However, as with all surgical procedures, there are inherent risks associated with Robotic-Assisted Surgery (RAS).

Risk strategies

At Premium Medical Protection, we are committed to supporting customers to reduce their risk profile and enhance patient safety. If you plan to perform RAS, you and your surgical team may find the following risk tips helpful:

1. Training and competency

It is essential that the surgeon has undergone training in the use of RAS both in technical skills, eg, using the robot, and non-technical skills, such as situational awareness. Once trained, it is important to maintain competence as detailed in GMC guidance Good medical practice, Domain 1 ‘Develop and maintain your professional performance’.

Situational awareness is vital for any surgeon using RAS, as the doctor is situated at a distance from the patient but must still be aware of what is happening by the bedside. This remoteness between surgeon, assistant, and scrub nurse can prove to be challenging.

In the UK, there are currently no formal mandatory guidelines, pathways or curricula for robotic training. Skills are usually acquired through a mixture of observership, mentorship with on the job training and fellowships. However, the Royal College of Surgeons of England (RCSE) and British Association of Urology Surgeons (BAUS) have published guidelines on training. Surgeons may find use of the Interpersonal and Cognitive Assessment for Robotic Surgery (ICARS) behavioural rating system helpful.

2. Team collaboration

In surgical teams, doctors work under time pressure and are highly dependent on other members of the surgical team, eg, anaesthetist, assisting surgeon and nurses. Therefore, a well-functioning team, where communication and speaking up is encouraged, is particularly important in order to achieve good quality treatment and enhance patient safety. To develop and support a competent and effective theatre environment, it is essential that all members of the surgical team receive comprehensive RAS training.

3. Patient selection

Careful pre-operative assessment of the risk a patient presents is critical in preventing perioperative complications. Both the patient’s comorbidities and the complexity of the robotic surgery are important risk factors that should be considered. One of the driving factors in the growth of RAS over the past two decades has been patient demand. However, some patients who are eager to access this technology may not be ideal candidates due to comorbidities or other factors, eg, obesity, diabetes, history of heart surgery, etc.

4. Managing patient expectations

In addition to establishing patient selection criteria, it is also crucial to manage patients’ expectations related to RAS. This may prove challenging for surgeons because the technology is complex, and direct claims about benefits and safety can be difficult to make.

5. Consent

Engage the patient in a thorough informed consent discussion, including a review of the risks, benefits, and alternative treatment options, in accordance with GMC guidance Decision making and consent. This discussion should include:

• The procedure the patient is having and how it is performed.
• The potential risks of robotic surgery in relation to equipment failures and malfunctions, such as:
  • system errors
  • video imaging problems
  • broken components
  • electrical arcing, sparking, and charring
  • unintended instrument movements
• The potential risks of robotic surgery in relation to the patient’s specific condition and comorbidities.
• The surgeon’s past experience with RAS in general and with the specific robotic procedure being recommended.
• 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 (eg, the surgeon will need to revert to open surgery or traditional laparoscopy), as well as any related risks.

Taking the time to provide patients with these details and answering any questions they may have can help ensure they have the appropriate information to make critical decisions about their treatment. Following the informed consent process, surgeons should document these discussions in patients’ medical records and include copies of any related consent forms. In addition, the anaesthetist should also conduct and document an informed consent discussion with the patient.

6. Converting to laparoscopic or open surgery

Establish a contingency plan for converting from a robotic procedure to a laparoscopic or open procedure. Be cognisant of, and plan for, any risks that may occur during such a conversion. The complexities involved in converting from RAS to laparoscopic, or open surgery can increase patient risks.

7. Record keeping

Document in the patient’s medical record any special actions taken before, during, or after the procedure that specifically minimised the risks associated with robotic surgery (eg, patient positioning or special monitoring). Ensure that you keep comprehensive and accurate notes in the patient’s medical records of all consultations/discussions with the patient.

Be open and honest with the patient and/or family – duty of candour

If the patient does unfortunately suffer an adverse event following or during the RAS, the clinicians involved have an ethical responsibility to disclose any unanticipated patient outcomes. It is essential to investigate, explain and apologise to the patient. For further guidance on your ethical obligations, please refer to the GMC’s Openness and honesty when things go wrong: The professional duty of candour. Whilst clinicians may feel uncomfortable and anxious discussing adverse outcomes with patients and/or families, when done properly, disclosure can reduce the negative impact of adverse outcomes and support a culture of transparency and safety.

If you receive a complaint from a patient, or a patient suffers an adverse event, please call the PMP medicolegal helpline as soon as possible. The PMP medicolegal helpline team, provided by Clyde & Co LLP (a law firm), can assist customers in preparing an appropriate response.