EXPERT ANALYSIS FROM SGS 2015

ORLANDO (FRONTLINE MEDICAL NEWS)The proportion of hysterectomies performed with robotic assistance has been growing steadily in the absence of objective evidence that this approach is superior to alternatives, according to Dr. David Grimes, an ob.gyn. at the University of North Carolina at Chapel Hill.

As part of his keynote lecture at the annual scientific meeting of the Society of Gynecologic Surgeons, Dr. Grimes cautioned surgeons that there are few randomized controlled trials of robotic hysterectomy, and published evidence has not established any use for robotic surgery in gynecology.

“Robotic hysterectomy is an expensive, unproven technology that is associated with a further degradation in the surgical training that our residents now get, and it is replacing the preferred means of hysterectomy, which is vaginal,” said Dr. Grimes.

He pointed to a 2009 committee opinion from the American College of Obstetricians and Gynecologists that cites vaginal hysterectomy as the approach of choice because it is the safest and most cost-effective way to remove a noncancerous uterus (Obstet. Gynecol. 2009;114;1156-8).

Dr. Grimes also cited a recently published joint committee opinion from ACOG and SGS that reviewed data suggesting that robotic hysterectomy has higher costs but no advantage in regard to morbidity, when compared with laparotomy for benign hysterectomies. For gynecologic malignancies, robotic surgery was found less expensive than open hysterectomy across multiple studies because of shorter hospital stays ( Obstet. Gynecol. 2015;125:760-7 ).

Data supporting the benefits of robotic surgery remain sparse, according to Dr. Grimes. He cited a Cochrane Review based on six studies that found there is only “low-quality” evidence on which to conclude that robotic hysterectomy is as safe as conventional laparotomy and only “moderate-quality” evidence that it reduces hospital stays ( Cochrane Database Syst. Rev. 2014 Dec. 10;12:CD011422 ). The authors of the review emphasized that more research is needed.

The United Kingdom’s National Health Service and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists have drawn similar conclusions, according to Dr. Grimes.

But even without clear evidence, the rates of robotic hysterectomy in the United States have been climbing at the same time that rates of vaginal hysterectomy have fallen, said Dr. Grimes, who estimated that approximately 2,500 U.S. hospitals now offer robotic surgery. The growth, he said, is due largely to “aggressive marketing.”

Dr. Grimes proposed that to protect patient safety, the use of robotic surgery should be restricted to formal clinical trial protocols approved by an institutional review board.

“Any use of the robot today off protocol is uncontrolled human experimentation,” he said at the meeting, which is jointly sponsored by the American College of Surgeons.

Dr. Charles R. Rardin, chairman of the SGS Program Committee and director of the robotic surgery program at Women & Infants Hospital of Rhode Island, said “the audience very much appreciated the candor and dedication” expressed by Dr. Grimes for high-quality evidence, but he did not offer a direct endorsement from SGS of the characterization of robotic hysterectomy as experimental.

“SGS has always hosted a vigorous and academic dialogue regarding the pros and cons of robotic surgery,” Dr. Rardin said. “We advocate well-designed research to determine which patients are likely to benefit from robotic surgery. We emphasize that case selection should be based on the best available relevant data as well as expert opinion, and surgical consent should include risks related to the robotic approach.”

Dr. Grimes and Dr. Rardin reported having no relevant financial disclosures.

obnews@frontlinemedcom.com

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