Evidence-based medicine Finance minimally invasive robotic surgery

How minimally invasive surgery was spun as the ‘latest and greatest’ for cervical cancer

How minimally invasive surgery was spun as the 'latest and greatest' for cervical cancer

Small incisions made by wands in laparoscopic surgery have been touted as a “breakthrough” for cervical cancer.

To know how minimally invasive surgery for cervical cancer turned widespread earlier than high-quality proof was out there about its outcomes, think about some rah-rah native information protection.

Again in 1995, for instance, The Report of Hackensack, N.J., reported that laparoscopy “made surgery simpler and less painful,” with a physician calling its tiny incisions a “breakthrough” for cervical cancer in contrast with open surgery involving a big minimize.

A 2008 story in the Amarillo (Texas) Globe-Information heralded the virtues of a hospital’s nine-month-old robotic surgery system, deemed a “success” by one doctor who suggested: “Patients should be seeking out this surgery.”

And a 2011 story in Carlisle, Pa.’s The Sentinel gave a lady’s glowing account of robot-assisted hysterectomy, which she stated led to “so little pain” that she needed to maintain reminding herself she simply had surgery.

These have been amongst a minimum of 20 one-sided newspaper tales that turned up in a ProQuest database search.

Such channeling of supplier hype partly explains why many have been surprised by a randomized trial revealed final week that discovered minimally invasive surgery truly leads to extra deaths of cervical cancer sufferers in contrast with conventional surgery.

Michael Gorin, MD, an assistant professor of urology, oncology and radiology at Johns Hopkins College Faculty of Drugs, tweeted:

Forward of strong knowledge, docs and the hospitals that woo them had rushed to undertake laparoscopy and robots, which got here for use for about half of radical hysterectomies for early-stage cervical cancers in the U.S.

We frequently sound an alert about newer-is-better advertising messages which might be promoted to the public with the assist of uncritical information reporting. It’s a very good time to resume our name to be cautiously skeptical whenever you hear gung-ho messages about minimally invasive procedures.

It’s essential to ask: What’s the proof for the security and effectiveness of a given process?

That message is shared by the lead researcher in the randomized trial that in contrast surgical methods for cervical cancer, Pedro Ramirez, MD, a professor of gynecologic oncology and reproductive drugs at Houston’s College of Texas MD Anderson Cancer Middle.

“There has been a tremendous marketing of the minimally invasive approach, including physicians marketing the uniqueness of their practice, saying ‘I’m the only one who does this approach.’ When you set a level of uniqueness about what you do, then automatically patients will think it’s better,” Ramirez stated.

The trial — coated final week by NBC, The Information York Occasions, The Related Press, and others — confirmed three-year general survival was 91.2% for sufferers who had surgery utilizing laparoscopy or robotic know-how, versus 97.1% who had conventional open surgery.

That discovering was bolstered by an observational research that linked minimally invasive surgical procedures to shorter survival.

Researchers stated extra research is required to elucidate why cancer recurred extra typically in the minimally invasive group. Some theorize that these methods may miss some cancerous tissue or inadvertently unfold cancer cells.

Amongst these stunned by the consequence have been researchers themselves, who pointed to the want for extra managed trials in surgery.

“Believe me, there were many times when I questioned myself,” stated Ramirez, who directs minimally invasive surgical analysis and schooling at MD Anderson. “I would say, ‘Well, is this really truly a good idea to pursue this and put so much effort into a study when we already knew the answer?’”

He stated the trial, which started in 2007, was extended as a result of many docs and sufferers didn’t need to take part. “(Doctors) at many centers said, ‘I cannot see myself randomizing my patients to the open surgery because we already know the minimally invasive procedure is better.’ We got a lot of push back.”

Docs relied on observational knowledge

Docs based mostly their beliefs on retrospective observational research that linked much less invasive procedures with much less blood loss, shorter hospital stays, and fewer problems. For knowledge on the limitations of such knowledge, see our toolkit on observational research.

Such potential advantages have figured prominently in advertising, together with the promise of quicker restoration and much less scarring.

Additionally problematic was that till now, there was solely weak observational knowledge to point out whether or not much less invasive methods are as efficient as open surgery in eradicating cancer.

Pedro Ramirez, MD

Advertising took off with little proof

As we’ve written, medical units are sometimes allowed to be marketed with little proof for security and effectiveness.

Minimally invasive surgical procedures jumped dramatically after 2005, when the da Vinci robotic was cleared by the FDA for use in gynecologic surgery.

In 2009 the Society of Gynecologic Oncology predicted widespread implementation of robotic surgery, for which sufferers with uterine and cervical cancer have been declared the “most viable candidates.”

DaVinci’s producer, Intuitive Surgical, funded coaching to allow gynecologic oncologists to make use of its system. In 2010 alone greater than 1,200 surgeons have been taught to make use of it, in response to one report.

Hospitals sink capital into surgical know-how

By 2014, about 1,500 U.S. hospitals had invested in a da Vinci at $1.5 million to $2 million apiece.

All the whereas, purported benefits of minimally invasive surgery have been heralded in advertising supplies, information releases, and some information protection.

Additionally they factored into some sufferers’ medical selections.

A lady interviewed final week by NBC stated she “chose minimally invasive thinking it was the best, latest and greatest and best thing to do.” Her cervical cancer recurred following surgery, the community reported.

Earlier cautions about robotic surgery

This isn’t the first time that robotic surgery hasn’t matched its hype.

We’ve written about ladies who incurred a life-threatening complication referred to as vaginal cuff dehiscence, a separation of a vaginal incision, which has been proven to be extra frequent after robotic hysterectomies.

There have additionally been cautions from skilled societies such as a 2015 opinion from the American School of Obstetricians and Gynecologists and the Society of Gynecologic Surgeons. Noting that “patient fascination with technology, industry pressure, and marketing efforts of hospitals and physicians have fueled the popularity of robot-assisted surgery,” the teams warned reporting of opposed occasions with the system is “voluntary and unstandardized, and the true rate of complications is not known.”

A 2013 assertion from ACOG stated: “Many women today are hearing about the claimed advantages of robotic surgery for hysterectomy, thanks to widespread marketing and advertising. Robotic surgery is not the only or the best minimally invasive approach for hysterectomy. Nor is it the most cost-efficient.”

Two information tales that cautioned about scant proof

To their credit score, two information tales that turned up in the database question additionally mentioned the proof void for minimally invasive procedures.

A 2010 Rochester (N.Y.) Democrat and Chronicle story famous a “scarcity of peer-reviewed studies on whether the surgical outcomes are better” with robotic surgery in contrast with different varieties of surgery.

The Louisville (Ky.) Courier-Journal reported in 2011 that some docs “are skeptical about the rapid spread of the technology,” It quoted urologic oncologist Hyung Kim, MD, of Cedars-Sinai, who stated the progress in robotic surgical procedures “has been fueled in part by marketing, not randomized clinical trials.”

“What’s driving robotic surgery is the perception it allows better operations. But we don’t know if that perception is true or not. We don’t have the empirical evidence,” Kim advised the paper.

Research was primarily funded by philanthropy

Extra proof seems to be on the approach. Ramirez stated his staff expects to publish long-term quality-of-life findings for cervical cancer sufferers which will problem assumptions about the benefits of minimally invasive procedures.

He stated the trial — which value an estimated $1 million — was funded primarily with philanthropic presents “from people who felt that surgical research needed to be supported.” Medtronic, which makes laparoscopic units, coated $125,000 of the value as a part of its general help of surgical analysis at MD Anderson, he stated.

Medtronic didn’t have a task in designing the research, in accordance with the revealed analysis.

Ramirez declared no competing pursuits relating to the trial. He acquired about $36,000 in business funds from 2015 via 2017, principally consulting charges from gadget makers, in line with the Open Funds website.

A name for extra surgery trials

Different randomized trials have proven comparable survival between minimally invasive and open surgery with regards to early-stage uterine, colorectal, and gastric cancer. Ramirez stated this trial’s unfavorable outcome ought to encourage trials of different surgical procedures.

“This should be a wake-up call to say we should put more resources into these trials, not just take the retrospective data and say, ‘Go with this,’” he stated.

Many agree, judging by the overwhelming constructive response to this Twitter ballot by interventional heart specialist C. Michael Gibson, M.S., M.D.

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