Friday, December 7, 2012

Is robotic surgery the “laser” of the 21st century?

An OR nurse with 40 years of experience told me that she thinks robotic surgery might go the way of the laser.
Like many good observations, it's simple and I wonder why I didn’t think of it myself. The fact that I didn’t think of it won’t stop me from running with it though.

Laparoscopic surgery was introduced in the United States in 1989. Before then, gynecologists had used laparoscopes to peek into the abdomen for diagnostic purposes and tie some tubes, but removal of organs had not been done much. General surgeons didn’t use laparoscopy at all.

Some intrepid surgeons in Europe started performing laparoscopic cholecystectomies and the technique rapidly spread to the US. The rest is history.

But there is a forgotten chapter of the story. In 1990, surgeons in the US were scrambling to take courses in laparoscopic cholecystectomy. It was hard to find a course that had openings. Many were sponsored by a company that made a YAG laser and the operation was originally called “laparoscopic laser cholecystectomy.”

Most surgeons abandoned the laser fairly quickly because it did not stop bleeding as well as old-fashioned cautery. Its use made the surgery take longer and result in an occasional unusual complication. The latter occurred because, unlike electrocautery which generally only burns the tissue that it touches, the laser beam kept going until it reached some tissue to burn. That something could have been the duodenum, liver or the diaphragm.

Now we have robotic surgery. So far for cholecystectomy at least, single-incision robotic cholecystectomy takes longer, is more difficult to do and may or may not be more painful than the standard 4-port laparoscopic procedure. Although touted as producing a better cosmetic result, proof that the larger umbilical incision is cosmetically better than the extra 5 mm incisions, which are usually not a concern for the average patient, is lacking. Postoperative hernia at the umbilical incision is also more common with robotic single-incision surgery.

Similar to the unusual complications seen with the laser, when robotic surgery goes bad, it really goes bad. So far, robotic cholecystectomy complications are not being reported in the literature but one hears rumors. Certainly, some unusual things have happened with robotic surgery of other organs.
There is a lawsuit based on malfunction of the robot which resulted in what the plaintiff is saying was an unnecessary conversion to open surgery.

A patient’s family successfully sued a surgeon for causing a duodenal injury during a robotic splenectomy. The patient died. It is unclear how that could have happened since the two organs are not really very closed to each other.

A woman in New Hampshire had both ureters severed during a robotic hysterectomy.

Another suit claims that the robot arms are poorly insulated which caused injuries to the intestine and an artery leading to the death of a 24-year-old woman after a hysterectomy.

The frenzy to buy robots continues but some warning signs are in the wind. I hear that a gynecology society is about to publish a position statement which will say that the use of the robot adds time and expense to procedures without impacting outcomes at all.

A big difference between the laser and the robot is cost. If I recall correctly the laser was about $100K while the robot goes for $1.5-2M plus a yearly maintenance contract of $150K plus disposables of up to $2K for every case.

Time will tell if, like the laser, the robot will end up sitting in a corner as an expensive place to hang lead aprons.

References:
Robot malfunction
Splenectomy case
Bilateral ureter injuries
Burns to intestine and artery

57 comments:

Anonymous said...

The robotic MVR/AVRs at my last facility took much longer, had longer recoveries, more post-op complications even though the patients tended to be younger. The minimally invasive robotics were even worse. Sure this is anecdotal and highly reliant on the skill of the surgeon and number of cases performed, but I think it's another reason to more closely examine use of robots in surgery. Just because you have the tools available (or for sale) doesn't mean they mist be utilized.

Anonymous said...

Nobody - and I mean NOBODY, who has seen the most severe complications of Robotic surgery, would ever wish to send a friend, a relation or anybody dear, to a robotic surgeon who is performing his first 100-150 procedures during the "learning curve period"....

RuggerMD said...

What about Robotic heart surgery?
Our surgeons seem very good and patients go home in a couple of days.
Disclaimer: I haven't looked up any papers on it.

Our competitor hospital bought a robot, we bought two.

Anonymous said...

As one of my very first teachers in Surgery told me once upon a time: "Surgery is not the art of performing surgery, on the contrary - it is the art of avoiding surgery". In other words: It is about careful patient selection, that is treating "responders" and not treating "non-responders". The Robot company and the Robotniks do not understand this concept. They have a number of reasons to be unselective: (a) It leads to higher revenues for the company (b) It gives the Robot-surgeon more "cases" [doctors with a backbone never talk about "cases", they are patients - our brothers and sisters]to train on in a shorter time thus speeding up the "learning". For the hospital-administrators and the people who have taken the economical and political decisions in purchasing the Robot there is also a third incentive: (c) It decreases the total cost of the Robot. Thus totally unmedical, unethical and morally questionable incentives; (a),(b) and (c) now dictate the conditions for Surgical activity. Isn´t that a shame?

artiger said...

I'm glad I practice in a rural hospital, and won't have to worry about purchasing and using a robot.

Skeptical Scalpel said...

Great comments all.

Interesting regarding heart surgery. RuggerMD, see the first anonymous comment. The comment refers to mitral and aortic valve surgery.

Ah,the learning curve. Quite a bit different than learning as a resident with a mentor on the other side of the table.

Regarding the last anonymous comment above, I agree. It is sad.

artiger, don't bet on it. Your administrators have probably discussed buying one already.

Anonymous said...

...and then there is a fourth incentive (d), but for the moment I keep it to myself. Just some clues: Athens and Cyprus....

rnraquel said...

When one of our most respected anesthesiologists, told me never to get robotic surgery, I started wondering about its efficacy.
Then when young, healthy patients started turning up in the ICU after "routine" robotic surgeries, I got really worried.

Skeptical Scalpel said...

Anon, I don't get it. Please tell me what (d) is.

rnraquel, these are the kinds of rumors I was talking about. Give us some details.

artiger said...

Scalpel, our hospital has 27 beds (critical access), and our CEO has better sense. Purchasing a new colonscope is a big deal for us. The mere mention of the word "robot" would bring laughter from all sides.

Believe me, it ain't gonna happen...and that's why I like it here.

Skeptical Scalpel said...

artiger, It sounds like you are in a good place.

Anonymous said...

This is laughable. You are all dinosaurs. I hope you all retire soon for the good of all patients. Keep lying to yourselves.

Anonymous said...

No wasn´t this an interesting posting, quote:

"...This is laughable. You are all dinoaurs. I hope you all retire soon for the good of all patients. Keep lying to yourselves..."

Well, when you have repeatedly encountered the suffering of patients and their families after being maimed by the Robot, then there is no space for laughter. And no there are nu lies on the contrary, we know who are lying, cheating and even worse than that...

Let us introduce the concept "Robotgate" - because when everything is out in the air, many other scandals will seem so pale, paler than your own "surprised" face.

Skeptical Scalpel said...

Well now, I hope we get some follow-up on this.

Laurie Mann said...

It seems like many women who get robotic hysterectomies, recover fine. However, the complications, especially bowel prolapse (which is a pretty horrifying complication for women who've been told they've had an "easy" surgery), seem more common among these women who have robotic hysterectomies due to cautery issues. It made me glad I had the old fashion hysterectomy with old fashion sutures and no real surprises.

Skeptical Scalpel said...

Laurie, thanks for the comment. I believe we will soon start seeing papers documenting the increase in complications with robotic surgery.

Anonymous said...

One way to look at the eficacy of the robot would be to look at the Medical Device Reporting and to see the problems and causes.

Skeptical Scalpel said...

Good idea. I'll try it.

Anonymous said...

That's if they file an MDR. I've heard lots of reasons why "it's not applicable in this case". just sayin

Anonymous said...

Interesting to read these posts. Will tell you that a lot of this is true, but a lot is also biased based on which side of the "Robotic War" you're on. For disclosure, I'm a Gen Surgeon, I have used the robot, and regardless of what you may have heard it has a place. Until you've actually used it, you can't grasp the potential advantage it brings in terms of visualization and fine manipulation of tissue in delicate areas. I've completed several lap choles that would probably resulted in open conversions without the added visualiztion that the robot provided. I've also done a couple of right adrenals with the robot that I probably wouldn't have even attempted with traditional laparoscopy.
That said, I have to agree that there are a number of people pushing their agenda with the robot. The "benefits" of the single incision are crap, plain and simple. I've used 4 5mm ports for my lap choles for over a year, and have seen enough of them over 2 months out to know that anyone who tries to argue better cosmesis from a single incision is just wrong. You can't see over 90% of the trocar sites. Certainly can't justify that potential benefit with the clearly documented higher complication rate that a single incision robotic lap chole has over traditional 4 port. Don't care who is trying to sell me that one, I'm not buying.
As for the comments about the "Robot" causing all of these major complications. Just like with any other instrument, the scalpel may cut but the person who is holding it is making the incision. Same goes with the robot. You can't pin the complications on the robot, it's the person who is operating it. Just as with any medical device, there are going to be failures, but more often than not if the person operating the device really knows what they're doing that technical failure won't be passed on to the patient in any significant manner. I think the biggest reason for problems with the Robot is that there is no real screening process for who is trained. The companies want to train whomever they can so their product gets used. I know wome surgeons who are "roboticly trained" who weren't very good without the robot and guess what? they're not very good with it.

Skeptical Scalpel said...

Very interesting comments and honestly, I can't disagree with most of what you said. I've had others tell me they can do things with the robot that that probably couldn't have done otherwise, but it's hard to say what percentage of cases that really is. Is it worth starting every case with a robotic so you might do 5% of cases differently.

I agree single incision surgery is baloney. I'm not sure how you get the GB out through a 5 mm incision. Maybe you can explain that.

I also agree that just like the stapler didn't make bad surgeons better, the robot won't either.

Anonymous said...

As an engineering student entering medical school next year, this conflict is very intriguing to me.

Ultimately, I view robotic operation as a fantastic tool--from a theoretical standpoint, we can design robots to do things that we will never be able to do with our bare hands and tools.

However, all engineering applications have to be built with a specific purpose--these robots should be built specifically to do things that we don't already do very well. Surgeries that require manipulation of devices inside the human body that would normally require a large incision (device implantation, spinal fusion, etc.) strike me as reasonable candidates for robosurgery development.

It's a concrete engineering law that the number of moving parts a device has increases its failure rate. As a mere student, I don't really have the perspective to say whether the procedures described above are relatively uncomplicated (though the way you're presenting them leads me to believe they are), but there is definitely a problem here.

In other fields that have had robotic revolutions, such as space exploration, we use robots to access areas that humans cannot go--if humans can already accomplish these procedures quickly, safely, and efficiently, then the increased maintenance costs, likelihood of failure, and specialized personnel required by robotics are all drawbacks which are taken on for either minuscule or nonexistent gain

To sum it up, "if it ain't broke, don't fix it."

Skeptical Scalpel said...

Thanks. I had not thought about the engineering side of the issue. I am aware of only the one case of robot malfunction that I mentioned in the blog.

Surgery is definitely complicated. Even cases as relatively simple as cholecystectomy can be quite difficult at times.

Anonymous said...

It has been argued that the Robot has potential advantages and can be used in complicated situations in which one might have problems with traditional lap surgery. The point is that seasoned surgeons who had their huge share of both open and lap surgery might find selected patients in which the robod is of advantage. BUT the bottom line is rather all the newcomers, who only get very short training in the robot and TOTALLY lack in surgical skills in the open (so to say). They are not keen to convert and tend to push matters into catastrophic situations. Once you have your disaster, we the non-Robotniks must come running to save what is left of the innocent patients. Robotics should only be preserved for seasonede surgeons having the broad surgical knowledge. Now that is a problem for the Robotic company, they want to make good money - at any cost. Cutting down the Robotic frenzy with 80-90 %, and saving that machine for specific patients, will not feed the company - right? So the unthoughtful and unclinical marketing must go on. This is our main problem!

Skeptical Scalpel said...

That is an interesting point. In a few years, there won't be any non-robotniks who can still do an open case. Then what?

artiger said...

I've got about 25 years (barring any of my own catastrophic events) of practice left...I could stand to be very popular when an open surgeon is needed. I wonder if big hospitals would send jets to come pick me up on such short notice?

Skeptical Scalpel said...

Artiger, They just might, but be sure it's a jet and not a medevac helicopter. See link http://t.co/CExMGAjm

Anonymous said...

...then more disasters is the reply. All of this until Patients and Patien-driven organizations start to come together. The lawsuits you have listed in your article were individual persons running their cases separetely. Then they decided to collect and tried to make a joint case of it (I don´t know the legal term for it - I am not American) but that motion was turned down. Once the amount of maimed and for lifetime disabled persons, start to increase, new attempts will be made for collective efforts to bring down the Dragon.
To Artiger I could say that there is another potentially dangerous situation, and that is when the patients have serious complications postoperatively. Not only immediate intraoperative disasters which demands immediate action. That is when "prestige" and "unprofessional lethargy" is the main way to delay action. They just don´t want to get out of their dreams of High-Tech Success, so the patients suffer a number of days until the situation gets out of hand. They just don´t want to accept that something potentially dangerous has happened and don´t want to perform secondary open surgery early in the deteriorating process!! Open surgery is a big no no in their brainwashed minds. When the final disaster is imminent, then they come screaming for help!! From natural reasons, I cannot get into details, just let us say that I have encountered that kind of situations a number of times! It is a big shame and highly unprofessional.

Skeptical Scalpel said...

Email me the details of some of those cases and I'll sanitize and post them.

artiger said...

Anon, I hear what you're saying. Please keep in mind that my offer of being jetted around was made somewhat in jest. Somewhat.

Anonymous said...

The concept is called "Multidistrict Litigation"
You can google: Case MDL No. 2381 Document 12, where the actual case can be found.
Artiger - I got your point. Actually as "a Company" in California usually brainwashes young surgeons to repeat as ducks in a pond: "This is the future" - I would like to retort THIS is possible in a near future: the fewer seasoned open surgeons there will be, the more they will need us to come and wash their laundry - even rather long distance! You might need at least a chopper, if not a Jet!

Anonymous said...

Some really great and thoughtful comments on the robotic problems, the hype on new technology, the problems with the financial parts, the complications and the administrators taken hostage by their own overoptimistic investment - which now has to pay off (regardless of clinical indications):

http://www.leanblog.org/2010/05/surgical-robots-are-great-unless-youre-not-trained-to-use-them/

Skeptical Scalpel said...

Good comments, all. The link to the Lean blog is worth reading. It brings up the interesting point of "the learning curve." Some surgeons say it takes anywhere from 200-750 cases to become proficient with the robot. Who's volunteering to be cases 1 to 199?

artiger said...

And Scalpel, how much difference is there really between 199 and 201? It's like board certification, just something that says you've jumped through enough hoops to make someone else happy.

Skeptical Scalpel said...

Artiger, yes, even the RRC is talking about going to competency based training instead of say you need 10 colectomies and 30 GBs etc to graduate from residency.

RuggerMD said...

The only real place that a robot for surgery is absolutely needed is probably in the spaceship that will take the astronauts to Mars.
I suspect an open belly in zero gravity makes for one hell of a mess.
However, blood in the belly under insufflation I am told comes together into little balls.
Seriously, it likely would be needed there (unless the astronauts get prophylactic appys and choles-which I hear is a plan now.)

Skeptical Scalpel said...

I guess the robot could be used in space and controlled from earth. Just hope that the datalink doesn't fail during the case or that a problem doesn't arise and conversion to open is not necessary.

Ari said...

My uncle had robotic surgery for lesions and tumors from prostate cancer. We were all anxious about it but the recovery time was minimal and his cancer has been in remission for months. Better training and improved technologies could make this a winner in the future.

Skeptical Scalpel said...

Ari, I am glad your uncle is doing well. However, I hope you understand that he might have fared just as well with surgery that di not involve the use of a robot.

Anonymous said...

And further a comment to Ari: Great to hear that your uncle is doing well, but you should also know that more and more data being accumulated these ten last years point at Watchful Waiting instead of surgery, as a viable option in many patients.A substantial amount of patients who do not require surgery, still are sent to surgery. The huge capital investment in Robot Surgery has to "pay off" - regardless if the indications are sound and solid or not. It should be noted that the "Robotniks" are those who most aggressively try to promote Prostate Cancer Screening, a very unsolide and dull tool for detecting "significant cancer". The Robot investment has to pay off! Note that the U.S. Preventive Services Task Force, just recently has recommended AGAINST prostate cancer screening.
http://www.uspreventiveservicestaskforce.org/prostatecancerscreening.htm
And guess what group is most upset over that....

Anonymous said...

Dark clouds on the horizon?

http://www.consumerinjurylawyers.com/intuitive-surgical-stock-price-expected-to-fall-as-da-vinci-surgery-robot-lawsuits-rise

Skeptical Scalpel said...

Thanks. If you click on the link, you will discover that the CEO of the company that makes the robot sold $50 million of its stock last month. Also, it mentions that a lot of lawsuits against the company have been file filed.

Anonymous said...

The increasing problems for the maiming Robotic gimmick and the company producing it, is also commented upon in Foxbusiness recently:

Quote:

"I have shared favorable views on Intuitive Surgical (ISRG) in the past, but I am cautious on this name now due to slowing prostate removals and concerns regarding growth in other areas. The company has attracted several lawsuits alleging quality issues".


http://www.foxbusiness.com/investing/2013/01/09/medical-device-companies-could-look-healthier-in-2013/

...and the upcoming lawsuits have drawn attention in two recent articles in San Francisco Chronicle:

http://www.sfgate.com/business/prweb/article/Da-Vinci-Surgery-Robot-Lawsuits-Now-Being-4120879.php

Quote:

"Da Vinci Surgery Robot lawsuits are now being investigated by Bernstein Liebhard LLP. Victims of serious injuries that occurred during robotic surgery procedures that utilized the Da Vinci Surgical System may be entitled to compensation"

Further;

http://www.sfgate.com/business/prweb/article/Da-Vinci-Surgery-Robot-Lawsuits-Mount-as-4162171.php

Quote:

"Da Vinci Surgery Robot lawsuits continue to be filed by plaintiffs around the country who allege use of the machine in hysterectomies and other procedures led to serious injuries, including surgical burns and tissue damage, Bernstein Liebhard LLP reports. According to a report issued by Citron Research on December 19, 2012, Intuitive Surgical, the manufacturer of the Da Vinci robot, has been named in nine such claims, including three that involved hysterectomies. Two of the lawsuits detailed by the Citron report are wrongful death claims".

Anonymous said...

Is anyone aware if the American College of Surgeons or any surgical specialty societies have made policy statements regarding the use of the Da Vinci robot?

Skeptical Scalpel said...

The only national organization that I am aware of is the AAGL (formerly the American. Association of Gynecologic Laparoscopists). I hear they are about to issue a position statement saying robotic hysterectomy is not worth the expense.

Anonymous said...

OK....here goes. I was diagnosed with one site (out of 12) in the spring of 2007. Figured I would have PC....dad had it and two male cousins, one on maternal and the other paternal also had PC. One was a renowned surgeon and wanted my dad to have surgery....Dad opted for radiation. LC got him...but I always wondered if the LC was triggered by the radiation. Turns out, my cuz, the MD went for hormone.

My Gleason score was low....the Doc said it would have been PRE-Cancerous 3 months earlier.

I had LOT of time to think and to evaluate. I am a professional with an Engineering degree and have had to make a LOT of decisions about equipment, people, scrap vs repair, etc in my career.
I listened to the MD that did the biopsy. A little younger than me. He said that he would have the DaVinci and finally said which one of their two certified surgeons he would prefer.

The surgery was a piece of cake. I was up..but later on, I had some issues. GASTRO, not DaVinci related. My system would not get regular again....so I had water diarehea....back to the hospital. Once I got my system back in sync, I progressed quickly.

My surgeon was a genius....probably played video games through Med School. My "manhood" responded quickly and my wife told me to slow down because our sex life was normal after 6 weeks. I had the magic pills, but only took them 5 or 6 times per month. I took them to speed healing of the nerve endings.

That has been 5-1/2 years ago. Everything is still in tip-top working order....and I am now almost 68. I gained a little weight and my BP almost required meds. I went on a Wellness Program and improved my diet and exercised. Lost almost 20% of my weight and two pants sizes. Interesting, my libido went into overdrive....picked up a little weight while I got my AFib under control. Then as I started losing weight, it has come back....my WIFE is happy, except when I am really charged up for extened periods of time....she calls me Slick in honor of our former Prez who had quite a sexual appetite.
I have recently seen all the commercials about BAD ROBOT SURGERY. Not EVERY surgery is as successful as mine. However, based on all the horrors of scapel surgery and the complications, the Robotic is the ONLY way to go. I know several men that have had the DaVinci and they all rave about it. Each had different surgeons in different parts of the state and different practices.

SO, if the surgeon is qualified, then the Robotic is the only game for me. If I had to do it over again, SAME deal....

Skeptical Scalpel said...

Thanks for telling us your story.

I'm not sure how taking "magic pills" speeds healing of nerve endings.

I would say you are most fortunate to have had such a great result. I hope you continue to enjoy good health.

Bad Robot Surgery said...

I've noticed the bad robot surgery commercials playing a lot recently

Skeptical Scalpel said...

I haven't seen those commercials. Where are they running and what do they say?

Anonymous said...

I think there is a ton of misinformation here. I am a board certified general surgeon with 16 yrs experience and use the robot on a regular basis. I have been in the same practice location my whole career. The Da Vinci robot should be viewed as another tool in the surgeon's toolbox. It should not be viewed as something that should always be used, nor should it be viewed as something that should never be used. Anyone who believes either of these two opposite extremes has an agenda.

I use it selectively. I frequently do single site cholecystectomy, and yes patients absolutely do have better cosmetic outcomes. The robot makes this much easier. The 3-D camera alone makes use of the robot worthwhile in difficult dissections. To say otherwise only shows ignorance.

The key with the robot, as with all medical devices, is to make sure you use it appropriately. The robot does not cause injuries. It only does what the surgeon tells it. A bad surgeon will be a bad robotic surgeon.

My prediction is the robot will be around forever. It is silly to think we sit at the apex of technical development in surgery. It will not go away, but it will probably get better. Surgeons who do not learn how to use the robot effectively will one day be as outdated as surgeons 25 yrs ago who refused to learn laparoscopy.

Skeptical Scalpel said...

Anon, thank you for your thoughtful and interesting comments. A lot has happened in the year and a half since I wrote this post.

It sounds like you are being very responsible and careful with the robot. That's good.

Your anecdote about the robot making single-site cholecystectomy easier is not supported by any literature to date. The jury is still out on whether robotic cholecystectomy is an improvement on standard laparoscopic cholecystectomy.

I am not the only one questioning whether the supposed better cosmetic result of the larger single incision which is also more hernia prone is worth it to avoid two or three 5 mm incisions which are nearly invisible 6 months later.

And the average elective lap chole usually does not require 3-D vision and increased cost for the equipment.

Anonymous said...

Please Google "the Citron report on robotic surgery" and every intelligent reader will find that a MAJOR backlash for this overhyped gimmick is in the coming...

Skeptical Scalpel said...

I had seen that report when it was first published. As you may have heard, Intuitive won its first lawsuit. A patient's family in Washington State alleged that a surgeon was not properly trained to do a robotic prostatectomy. See story here http://www.bloomberg.com/news/2013-05-23/intuitive-wins-trial-defeats-negligent-training-claims.html.

Anonymous said...

Memorial Sloan-Kettering closes a randomized prospective trial after interim analysis. No difference between Robotic cystectomy with Ileal conduit versus Open with the same urinary diversion.

http://www.aua2013.org/webcasts/webcasts.cfm?id=PLIIM-6_Laudone

My conclusion (and many with me), the new "technique" failed to show any significant differences.No improved outcomes.It is a paradigm in the medical world: a new method should offer significant improvements before being introduced. If no differences, the standard "old" method should not be abandoned. End of story

Skeptical Scalpel said...

Thanks for the link. I had read about the paper. The robotic proponents have dismissed it as a bad study. They say the MSK urologists were not experienced enough and many other objections.

Anonymous said...

Well "The Robotic Proponents" are one crew of people, and the highly distinguished and renowned Urological Surgeons of MSK a totally different set of people.There are matters in Urological science, in which I differ from the highly respected scholars and Urological surgeons you find at MSK, but that is another issue. MSK has once again gained in esteem and added to their internationally excellent reputation by the described decision to discontinue the trial. World Urology needs more of that kind of high morals and unbiased evaluations. We aren´t monkeys in a circus running around to the grab as many bananas as possible in the shortest time...at least not all of us!

Skeptical Scalpel said...

Anon, thanks for your comments. It is an interesting debate.

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