Robot-assisted surgery has grown more than 25% annually, but committee recommendations from the American College of Obstetricians and Gynecologist (ACOG) note there are no high-quality data on cost, patient outcomes, or safety to support its rapid adoption for gynecologic surgery.
Well-designed randomized controlled trials (RCTs) or "comparably rigorous non-randomized prospective trials" are needed to establish the benefits and risks of robot-assisted gynecologic surgery, the Committee on Gynecologic Practice for the Society of Gynecologic Surgeons said in an opinion published in the March issue of Obstetrics & Gynecology. The American Urogynecologic Society also endorses the opinion.
The four existing RCTs comparing robot-assisted surgery for benign gynecologic disease with laparoscopy fail to show any benefit from robotic surgery, the committee notes. There are no data from RCTs testing robot-assisted gynecologic oncology surgery.
The ACOG and Society of Gynecologic Surgeons recommend the creation of a registry for robot-assisted gynecologic procedures and the use of the Manufacturer and User Facility Device Experience Database to report adverse events. Reporting is currently voluntary and unstandardized, masking the true rate of complications.
In addition, the committee recommends robot-assisted cases be selected on the basis of available data and expert opinion. Surgeons should be skilled in both abdominal and laparoscopic approaches for a procedure before turning to robotic approaches, the committee advises.
Institutions should establish surgeon training, competency guidelines, and quality metrics, with ongoing quality assurance to ensure patient safety and appropriate use of the technology, the report advises.
In addition, the committee recommends that informed consent be obtained before embarking on a robotic procedure; the discussion should include the risks and benefits of the technique compared with alternative surgical approaches and other therapeutic options. Surgeons should also describe their experience with the robotic-assisted surgery.
The ACOG and Society of Gynecologic Surgeons recommend credentialing and privileging for robotic procedures with standards that include completion of didactic training in a residency or fellowship from accredited organizations and hands-on training, when possible provided in a laboratory setting with animal subjects or human cadavers. Once training is completed, patient selection should be based on benefit to the patient; "cases should not be selected for the purpose of satisfying a quota." A surgeon's initial cases should be proctored by a surgeon experienced in robotic surgery. Institutions should determine the number of procedures required to demonstrate competence.
Obstet Gynecol. 2015;125:760-767. Full text
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Cite this: ACOG Issues Guidelines for Robot-Assisted Gynecologic Surgery - Medscape - Feb 23, 2015.