Although increasingly popular, robotic surgery has been shown to be risky and expensive, so guidelines for its use issued recently by the American Congress of Obstetricians and Gynecologists (ACOG) and the Society of Gynecologic Surgeons (SGS) should be required reading for anyone considering the procedure.
Promoted as a minimally invasive procedure for a wide range of problems involving many different body parts, robotic surgery is performed by a surgeon directing remote-controlled instruments from a console, often working in spaces smaller than human fingers can access. But in addition to causing problems such as burning and bleeding that are complicated by surgeons’ lack of training and conflicts of interest, robotic surgery is more expensive than more traditional surgical procedures, and the outcomes are equivalent.
As the ACOG report said, “Initially developed for battlefield medicine, robot-assisted surgery was approved by the [FDA] 1999 for urologic and cardiac procedures and in 2005 for gynecologic surgery. Today, robot technology is applied widely in gynecology for hysterectomy, sacrocolpopexy [repair of prolapsed, or slipping, pelvic organs], myomectomy [removal of uterine fibroids], adnexal surgery [appendages of the uterus] and malignancy staging [determining how far cancer has progressed].”
Robot-assisted surgery, said ACOG, is performed at more than 2,000 academic and community hospital sites in the U.S., and its use is growing annually by more than 25% annually. It’s no coincidence, as we’ve written, that use of surgical robotic equipment has grown in tandem with hospitals’ purchase of it – it’s a profit center, and it’s heavily marketed by the hospitals that own it and the industry that sells it.
Too often, we’ve noted, patient safety has fallen through these growth cracks, and now at least some professional medical organizations are addressing it. As the ACOG report stated, “Hospitals and physicians actively advertise and promote robotic surgery programs, often with unsubstantiated claims of improved outcomes and patient safety. The purpose of this Committee Opinion, developed by the [Congress] and SGS, is to provide background information on robot-assisted surgery for gynecologic conditions, review the literature on this topic and offer practice recommendations.”
Solid scientific data about robot-assisted surgery is sorely missing, and ACOG/SGS wants to improve that situation, too – after all, you can’t (or shouldn’t) set policy if you don’t have an evidence-based foundation for it. Although the recommendations are an example of how fact chases desire, at least they’re better late than never.
Specifically, ACOG/SGS recommend:
- Well-designed randomized controlled trials (RCTs) or comparably rigorous nonrandomized prospective trials to determine which patients are likely to benefit from robot-assisted surgery and to establish the potential risks.
- Robot-assisted cases should be selected based on the available data and expert opinion. As with any surgical procedure, repetition drives competency. In addition to the training necessary for any new technology, ongoing quality assurance is essential to ensure appropriate use of the technology and patient safety.
- Adoption of new surgical techniques should be driven by what is best for the patient, as determined by evidence-based medicine rather than external pressures.
- Adequate informed consent should be obtained from patients before surgery. For robotic procedures, this includes a discussion of the indications for surgery and risks and benefits associated with the robotic technique compared with alternative approaches and other therapeutic options.
- Surgeons should describe their experience with robotic-assisted surgery or any new technology when counseling patients regarding these procedures.
- Surgeons should be skilled at abdominal and laparoscopic approaches for a specific procedure before undertaking robotic approaches.
- Surgeon training, competency guidelines and standards to measure them should be developed at the institutional level.