Health News Review

To a man with a new hammer, everything looks like a nail.

To a hospital and/or surgical team with a new robotic surgery system, everything looks like a prime candidate for the robot.

And then there’s this about “off-label” use of the robot for thyroid surgery:

Reuters Health reports:

“Surgery to remove part of the thyroid gland is twice as expensive when it’s done with the help of a robot rather than by a surgeon alone, according to a new study. …

(Dr. James Broome) told Reuters Health that the findings are in line with data on a range of robotic surgery uses.

“None of those procedures have shown any improved outcomes for the patient,” he said. Patients “should be very cautious about whether it actually does anything better for them.”

 

 

 

 

Comments

Greg Pawelski posted on August 24, 2012 at 11:28 am

Tulane University School of Medicine surgeon Dr. Emad Kandil was one of the first in the country to perform the da Vinci endoscopic surgery on the thyroid. The technique safely removes the thyroid without leaving so much as a scratch on the neck. Traditional thyroidectomies can involve a long incision at the base of the neck. Tulane’s press release about this in 2009, says the technique was approved by the FDA during the summer of 2009. So, was it approved by the FDA or not? Is this really done “off-label” or not?

    Gary Schwitzer posted on August 24, 2012 at 12:40 pm

    Greg:

    In the Archives of Surgery paper, the authors note:

    “Surgeons should also be aware that, in October 2011, the Food and Drug Administration revoked approval for the use of the robotic system for thyroidectomy and parathyroidectomy. It is unclear what prompted this withdrawal by the Food and Drug Administration, but further use of the robotic system to conduct thyroidectomy must be considered off-label use of the technology.”

Harold DeMonaco posted on August 29, 2012 at 7:30 pm

The transaxillary approach for thyroidectomy has the distinct cosmetic advantage in that the scar is under the armpit rather than the neck. As usual, the number of cases performed by the surgeon is an important determinant of the risks of the minimally invasive approach. At issue then is the skill of the surgeon and not the approval of the FDA for the device. As appealing as it is, the robot assisted procedure has a theoretical risk of incomplete removal of the thyroid balancing the cosmetic advantage. (see: Journal of the American College of Surgeons. 214(4):558-64; discussion 564-6, 2012 Apr.)

James Broome posted on September 10, 2012 at 2:19 pm

Obviously I have an opinion on this paper, but I think the point it was attempting to make is that the only benefit for this robotic procedure is cosmesis. All other outcomes, in highly skilled hands, are the same. The cost is significantly higher with no adjustment made in the billing of the procedure to account for the difference in cost. Therefore, the system as a whole pays for a cosmetic decision with no therapeutic benefit. “Traditional thyroidectomies can involved a long incision in the neck” — the competent Thyroid Surgeon with the skills tobe doing robotic cases likely completes their surgeries through a small 4 to 6 cm incision for the vast majority of cases. Finally, in regards to the volume/skill of the surgeon, even in the highest volume centers it will be difficult to reach the 40 to 50 patients needed to reach “equivalent” results for the technique. Dr. Kandil has widely utilized this technique, but routine acceptance of this should be questioned.