RALP vs. open surgery: “similar functional outcomes at 12 weeks”

Back in July we reported the initial publication on line of the results of a randomized Phase III trial by Yaxley et al. that compared the initial outcomes of open radical retropubic prostatectomy to robot-assisted laparoscopic prostatectomy (RALP). This paper has now been published by The Lancet along with two sets of editorial commentary.

To quote the relevant editorial in The Lancet:

John Yaxley and colleagues report the early outcomes of the first randomised trial comparing these two techniques and find no difference in quality of life outcomes at 12 weeks. The final results are awaited with interest. The authors of the Article, and the patients randomised, should be congratulated on a huge achievement in undertaking this long awaited trial. A randomised comparison was thought, by many, to be impossible due to “inherent biases both from a patient and clinician perspective” as Erik Mayer and Ara Darzi explain in their accompanying Comment.

However, let’s also note the title of that editorial, which is “Robotic surgery evaluation: 10 years too late”.

For the interested reader, here are all of the relevant links to:

Unfortunately, only The Lancet‘s editorial is available in full to non-subscribers to the journal.

We should be very clear up front that 12 weeks is certainly not long enough to be able to tell whether either open surgery or RALP is “better” in terms of long-term outcomes. RALP is known to be better in that it is associated with less blood loss during the procedure, a shorter post-surgical recovery time, and (at least for some patients) a lower need for medication to address post-surgical pain. However, it is planned to follow all these patients for another 2 years. At that point in time, we will be a good deal wiser than we were prior to the initiation of this trial.

What is very clear from this paper, however, yet again, is our failure (as a medical culture) to make quite sure, and in a timely fashion, that every new technology actually provides the benefits that the developers and marketers of that technology are telling us that it offers. It may well be that we have now made this mistake twice in the past 20 years in the management of prostate cancer alone — and with enormous cost implications: first, through the near-to universal adoption of RALP and then with the construction of many proton beam radiation centers. In neither case was there any clinical data available to demonstrate unequivocally that the new technology actually provided the benefits touted by its advocates.

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