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Just Ridiculous
by FeTuS

What an ignorant article....

The robots themselves arent doing the surgery.... the surgeon is. Robotic surgery is an inovative extension of laparocscopy. You gain 360 degree range of motion (lacking in laparoscopy) at the price of losing tactile feedback (present somewhat in laparoscopy). As with any new technology, there will be a learning curve. It is not suprising that long term prostate cancer recurrances were higher in the laparoscopy/robotic group. Over time as experience is gained, this may or may not change.

The author talks about biased studies and quotes this poor article as evidence of robotic inferiority. The level of evidence of this cited article is terrible. It is not randomized. It is not prospective. Robotic and laparoscopy were grouped together. So really it is a retrospective, non- randomized, non-blinded comparison of minimally invasive surgery versus open surgery. It provides little valuable information. No objective scientist would accept this article as anything more than passing interest.

As a surgeon, we generally want anything that will help us treat our patients better. The verdict is still out on robotics. But if I use a robot, that is not "heartless". It is mearly another instrument of healing in my hands.

Re: Just Ridiculous
by Bondsman

I had to laugh when I read your post. Like any group of urologists is going to do a large-scale prospective randomized trial between robotic-assisted prostatectomy and "normal" prostatectomy... I think not. What if the robots were proven to be worse? How many tens of millions worth of hardware would have to be thrown out? Nope, won't ever happen. Not when the people who have ALREADY BOUGHT the robots are the ones who decide whether or not the trial is worth doing

And it's all well and good to try and write this off as a "learning curve" with the procedure - unless YOU are the one who is going to die because of your surgeon's ignorance.

You want to claim that the study's data is incorrect? PROVE it.

Re: Just Ridiculous
by FeTuS

A typical misread of someone's comments.

I did not say the study was inaccurate. I simply stated what type of study it is. At best, this study is level II-2 or level B evidence. My stating this is showing objectivity. When reading literature, you have to evaluate the quality of the study to interpret the results. Its science 101. Do you want to take this study as gospel????? If so, you will have to change your position every few months when another retrospective study has different findings. There are just too many biases in these retrospective studies to find consistent results.

As to the learning curve point, please read the paper. The authors themselves state this probable bias.

Will there ever be a large randomized controlled trial? I agree probably not. It would be expensive and likely take a long time. Thats the down side of surgical studies.

Im not a urologist. I rarely do robotic surgery. i have no agenda in this post. My point is: be objective. The author and Bondsman seem not to be.

Re: Just Ridiculous
by Bondsman

You missed the point.

The point is there is no, and never will be a large scale comparison of RP versus LRP. Therefore, it's silly of you to criticize the medicare data, because this is the best large scale data there will ever be.

Since you sound familiar with studies, you must realize that even a prospective, randomized trial (normally the "gold standard") is WORTHLESS if it has only an hundred or so people in it IF you are interested in picking up a *small difference* in efficacy - say a few percent or so.

Why is this important? It's important because if you have an expensive new piece of hardware you want to sell, you can run several *small* studies and say there's ***no difference*** in survival between it and the procedure you are replacing, knowing full well before you even run the study that will be the case unless there is a very LARGE difference. So the laparoscopic procedure has less side effects and shorter hospital stays. If there was (hypothetically) a 3% WORSE chance of tumor recurrence, but a 10% better side effect profile, wouldn't you rather go with the other procedure that has a better chance of curing you? With cancer, you probably would. And the point is... none of the randomized studies you tout are ever going to show that difference, but a large retrospective study or metaanalysis might.

That is why the medicare study is important.

BTW, I'm not adverse to laparoscopic procedures, the people I know who perform them say the feel they get *better* visualization for some things than with an open procedure. The point is though if for whatever reason they aren't working as well *on a case by case basis*, this needs to be rectified - wouldn't you agree?

Re: Just Ridiculous
by FeTuS

Excellent!

I think we completely agree but were coming at it from different angles. I could not agree more with everything you just said.

My main critique with the actual Slate article is the use of the word "heartless" to describe robotic surgery. A robotic arm vs a laparoscopic tool vs a scalpel are all equally "heartless". It is the humanity of the surgeon and the patient that bring "heart" to the OR.

When RTCs arent possible, the best we can do is be guided by large scale retrospective studies, expert opinion, and old fashion experience... and always remember to first do no harm.

Re: Just Ridiculous
by gzuckier
Bondsman:

I had to laugh when I read your post. Like any group of urologists is going to do a large-scale prospective randomized trial between robotic-assisted prostatectomy and "normal" prostatectomy... I think not. What if the robots were proven to be worse? How many tens of millions worth of hardware would have to be thrown out? Nope, won't ever happen. Not when the people who have ALREADY BOUGHT the robots are the ones who decide whether or not the trial is worth doing

And it's all well and good to try and write this off as a "learning curve" with the procedure - unless YOU are the one who is going to die because of your surgeon's ignorance.

You want to claim that the study's data is incorrect? PROVE it.

don't know about large scale study, but as new laparascopic surgeries get innovated for various procedures, starting with gall bladder surgery and moving up, hospitals certainly do serious comparative studies to see if the rate of negative outcomes is worse for the new surgery than the old. studies which are both statistically and medically sound. i know because that's how i made my living for a couple of years.

Re: Just Ridiculous
by gzuckier
Bondsman:

You missed the point.

The point is there is no, and never will be a large scale comparison of RP versus LRP. Therefore, it's silly of you to criticize the medicare data, because this is the best large scale data there will ever be.

Since you sound familiar with studies, you must realize that even a prospective, randomized trial (normally the "gold standard") is WORTHLESS if it has only an hundred or so people in it IF you are interested in picking up a *small difference* in efficacy - say a few percent or so.

Why is this important? It's important because if you have an expensive new piece of hardware you want to sell, you can run several *small* studies and say there's ***no difference*** in survival between it and the procedure you are replacing, knowing full well before you even run the study that will be the case unless there is a very LARGE difference. So the laparoscopic procedure has less side effects and shorter hospital stays. If there was (hypothetically) a 3% WORSE chance of tumor recurrence, but a 10% better side effect profile, wouldn't you rather go with the other procedure that has a better chance of curing you? With cancer, you probably would. And the point is... none of the randomized studies you tout are ever going to show that difference, but a large retrospective study or metaanalysis might.

That is why the medicare study is important.

BTW, I'm not adverse to laparoscopic procedures, the people I know who perform them say the feel they get *better* visualization for some things than with an open procedure. The point is though if for whatever reason they aren't working as well *on a case by case basis*, this needs to be rectified - wouldn't you agree?

oh well yeah, long term effects are, of course, the achilles heel of the short term followup study. a zillion years ago when i had my hernia repair (too much information) they were just bringing in the laparascopic repair which was a pretty quick and trivial affair, but my surgeon basically believed that since I was still young and this would have to last 50 years, he would go with the old "tried and true" until further data came in on the longterm reliability of the laparascopic repair, despite it putting me out of commision for a week. can't argue with that, really.

Re: Just Ridiculous
by Bondsman

FeTuS,

You're probably right, if we sat down for a bit more on this, we probably would end up in the same place. I don't know why the guy would think one technique is more "heartless" than another, maybe you need a zinger of some sort to get published in Slate?

Re: Just Ridiculous
by Bondsman

Gzuckier,

You said,

"don't know about large scale study, but as new laparascopic surgeries get innovated for various procedures, starting with gall bladder surgery and moving up, hospitals certainly do serious comparative studies to see if the rate of negative outcomes is worse for the new surgery than the old. studies which are both statistically and medically sound. i know because that's how i made my living for a couple of years."

I have a confession to make. Before posting earlier I ran a quick search on LRP vs. RP and couldn't find anything big - less than 100 people per arm is all I came up with. I figured I'd look like more of a tool than usual if there were a bunch of 5000 person studies sitting around readily available. There still may be, I didn't spend a lot of time looking, but I don't think so.

Also, I agree with your old doc, if some new technique does NOT show a significant increase in survival, why not let someone else's patients take the initial risk? Same thing with new meds, if you can wait a few years before getting on the bandwagon, you have a lot less explaining to do.

Re: Just Ridiculous
by gzuckier
Bondsman:

Gzuckier,

You said,

"don't know about large scale study, but as new laparascopic surgeries get innovated for various procedures, starting with gall bladder surgery and moving up, hospitals certainly do serious comparative studies to see if the rate of negative outcomes is worse for the new surgery than the old. studies which are both statistically and medically sound. i know because that's how i made my living for a couple of years."

I have a confession to make. Before posting earlier I ran a quick search on LRP vs. RP and couldn't find anything big - less than 100 people per arm is all I came up with. I figured I'd look like more of a tool than usual if there were a bunch of 5000 person studies sitting around readily available. There still may be, I didn't spend a lot of time looking, but I don't think so.

Also, I agree with your old doc, if some new technique does NOT show a significant increase in survival, why not let someone else's patients take the initial risk? Same thing with new meds, if you can wait a few years before getting on the bandwagon, you have a lot less explaining to do.

yeah, when i said the hospitals were doing comparative studies, i meant on their normal patient flow (with the additional proviso that the subjects weren't randomly assigned or anything; the doctor decided on whichever method he/she preferred), the study was restricted to looking at the results of whatever last quarter/year's surgeries were. it wasn't intended to be publishable research, just quality control. in fact, the local hospitals pooled their data so we could get some reasonably sized numbers. we actually did find one hospital that was doing pretty badly one year on one of their laparascopic procedures; it turned out they weren't doing as much imaging before the process as everybody else. (that's what i mean by medically valid; the surgeons had input on what variables should be collected, not necessarily for the study itself, but for later interpretation). they seemed surprised firstly to find out that they were doing badly on outcomes, then to find out that they weren't doing the imaging. no resistance or defensiveness, just "thanks for letting us know" and fixing the problem.

on the other hand we found another hospital that had bad outcomes one year and they ended up pulling all the relevant charts and doing a chart review; it turned out that the "victims" were all residents of a local nursing home which was presumably doing inadequate postoperative care, not the hospital's fault. (we've been having periodic nursing home scandals here, like a lot of places).

i guess the bottom line is that there are such large-scale variables which affect short-term outcomes and aren't always things that get included in the study a priori that the subtle effects attributable to the nature of the procedure itself that you really want to study get masked. and as you say, long term effects aren't known at all until large longterm studies get done, so don't be the first on your block to try something.

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